Category: Medicine

Image credit: koolsabuy | stock.adobe.com Two-year data from the Phase III Pagoda and Pavilion studies demonstrate that Genentech’s Susvimo (ranibizumab) injection 100 mg/mL produced sustained efficacy in patients with diabetic macular edema (DME) and diabetic retinopathy (DR), respectively. The FDA accepted a supplemental Biologics License Application (sBLA) for Susvimo based on one-year results showing non-inferior […]

Image Credit: Adobe Stock Images/VisualGeneration.com Systech, a provider of digital identification and traceability solutionsfor the pharma industry, was selected by Praxis Packaging Solutions to provide a track-and-trace platform for supply chain transparency.1 This partnership grants Praxis customers access to aggregation and product tracing services that are able to meet global compliance requirements, such as the […]

PC: ixlayer recently released the results of a new survey that unveiled insights into provider attitudes toward at-home diagnostic testing in healthcare. Could you describe the process that went into designing the survey itself? Walsh: What ixdoes does is serve as a technology platform that builds direct-to-patient experiences that facilitate remote testing and connection to […]

Some could make the argument that the 340B drug discount program1 is broken and bears little resemblance to what its creators envisioned in 1992. It was designed to ensure that safety-net healthcare providers, called covered entities (CEs), could continue to access low-cost drugs for their patients from drug manufacturers. The program mandates that manufacturers provide […]

Image Credit: CordenPharma CordenPharma, a full-service contract development manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, drug products and packaging services, will invest approximately $984 million (€900 million) over the next three years in order to enhance its peptide technology platform.1 These initiatives feature two major expansion plans in the United States and Europe that […]

Image Credit: Business Wire, Catalent Catalent, a contract development and manufacturing organization (CDMO), has completed expansion of its clinical supply plant in Schorndorf, Germany.1 The Schorndorf site—which offers clinical supply services, such as packaging, storage and distribution— is considered the CDMO’s flagship European facility and has been in operation since 1996. The development project grows […]

Upperton Pharma Solutions’ large processing room. Image Credit: Upperton Pharma Solutions At its 50,000 square-foot development and current good manufacturing practice (cGMP) facility in Nottingham, UK, Upperton Pharma Solutions, a contract development and manufacturing organization (CDMO), has completed a Medicines and Healthcare products Regulatory Agency (MHRA) inspection.1 The inspection follows the completion of the construction, commissioning, […]

Image Credit: Adobe Stock Images/Shutter2U.com INCOG BioPharma Services, a contract development and manufacturing organization (CDMO) whose focus is on sterile injectable biopharmaceuticals, is furthering its manufacturing services with the construction of a second 100,000 square-foot building on its campus in Fishers, IN.1 The project—scheduled to break ground in August—is expected to enhance the CDMO’s commercial-scale […]

Image Credit: Adobe Stock Images/DouceFleur.com As some may be aware, rheumatoid arthritis (RA) is an inflammatory joint disease that can result in not only permanent joint destruction, but overall physical and mental impairment.1 As a way to combat RA, methotrexate has been prescribed for safety and efficacy purposes, but more than 50% of patients have […]

Femasys Founder Discusses Femaseed Technology Designed to Support Infertility In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, offers a description of how Femaseed works to support women who struggle with infertility. Patients with Type 1 Diabetes Have Higher Risk of Epilepsy A new meta-analysis has showed that people […]

Can Data and AI Deliver Whole-Person Health? Executives in the life sciences and medical device industries see promise in artificial intelligence (AI) and medical technologies, but must also navigate the changing healthcare ecosystem, varied stakeholder needs, and the impact of AI on market access and commercialization strategies. Study Connects Multivitamin Use With Mortality Risk Daily […]

What is the Secret Sauce to Convert Academic Ideas to Valued Offerings That Prospective Buyers Crave? A Harvard Business School Healthcare Alumni Association Q&A with Penn Center for Innovation’s Michael D. Moisel, MS, MBA. Michael D. Poisel, MS, MBA, is responsible for managing Penn Center for Innovation (PCI) Ventures (PCIV), assisting the principal investigators with […]

The Weight-Loss Gold Rush: Legal and Regulatory Implications Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers […]

Image Credit: Adobe Stock Images/VictoriaKey.com Merck has now officially acquired Eyebiotech Limited (EyeBio), a clinical-stage ophthalmology biotech company.1 As a result of owning all of EyeBio’s outstanding shares, the deal is valued as high as $3 billion; this includes a cash payment of $1.3 billion, along with the possibility for an additional $1.7 billion in […]

New laws aimed at safeguarding personal information are reshaping how companies interact with consumers and healthcare professionals (HCPs). In this article, we’ll explore the challenges and opportunities presented by this new era of consumer privacy, providing a roadmap for navigating compliance complexities while connecting consumers to vital healthcare information. Overview of consumer privacy legislation and […]

Image Credit: Adobe Stock Images/Kirill Gorlov Rentschler Biopharma SE, a contract development and manufacturing organization, announced that its new advanced production line in Milford, Massachusetts in now fully operational. According to the company, the product line represents the largest investment in its 150-year existence. Known as the Rentschler Biopharma Manufacturing Center, the facility reportedly doubles […]

PC: How do drug shortages directly impact patients? Ax: I think about the patient as on a continuum. At the low end of the spectrum, you have patients who can’t get the drug at all, and at the high end of the spectrum, you have patients that can get the drugs and be on therapy. […]

The fundamental goal of patient support programs—whether it’s a hub, patient assistance program (PAP), or adherence support services—is to expedite patient access to therapy. However, the reality of that goal sometimes falls short of expectations due to linear and rigid pathways, which can cause significant medication access delays. On average, some outdated patient support models […]

PC: According to the American Society of Health-Pharmacists (ASHP), ongoing and active drug shortages are the highest they’ve been since the association began tracking this in 2001. Could you elaborate on why that is, along with sharing your thoughts on the current landscape of shortages in general? Ax: Well today, there are, by latest count, […]

Image Credit: Adobe Stock Images/DARIKA.com In a world where the cost of healthcare is top of mind for many, it may come as no surprise that high drug prices increase the chance of medication nonadherence. Drug prices in the United States are two to three times higher compared to other nations, and these numbers are […]

Image Credit: Adobe Stock Images/inimalGraphic.com MedPharm, Ltd. and Tergus Pharma, have decided to combine their efforts. Together, they are forming a topical and transepithelial contract development and manufacturing organization (CDMO) that will function under the MedPharm name.1 The end result is a CDMO that offers end-to contract services—including early phase research, formulation development, and in […]

Although the calendar might indicate that Q3 2024 is officially underway, the International Air Transport Association (IATA) just released data for May 2024—as this in-depth analysis takes time to process—which point to global air cargo market demand maintaining its yearly growth in demand.1 Total demand, measured in cargo tonne-kilometers (CTKs), climbed by 14.7% compared to […]

SGS North America—a company consisting of a network of contract service laboratories that offers pharma development, biologics testing and characterization, quality control testing, and biosafety—is implementing new capacity and capabilities in order to further boost its biologics testing services for the American biopharma market.1 The new project will be centered around SGS’ Lincolnshire Center of Excellence, […]

With CEO Turnover Rising to Record Levels, How Can Incoming, Existing Executives Build a Sustainable Role? A Q&A with Russell Reynolds’ Global Lead of CEO & Executive Transition Practice, Ty Wiggins, PhD. FDA Approves New Drug Application for Tepylute to Treat Breast, Ovarian Cancer Tepylute is a ready-to-dilute, injectable formula that reduces preparation time and […]

AI’s Promise in Delivering on Patient-Centricity How pharmaceutical companies can utilize AI at key stages of the treatment journey to enhance patient-centric engagement by increasing empathy and humanity in patient interactions. What’s Complicating Good Data Practices and Data Integrity? As the data management landscape continues to shift and change with AI and technological advancements all […]

Industry Leaders React to FDA’s Newly Announced Diversity Action Plan Guidance Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA’s Diversity Action Plan guidance. How Integrating Research Into Private Pharmacy […]

What Needs to be Done to Cover GLP-1? In this part of his Pharmaceutical Executive video interview, Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, and what needs to be done […]

Image Credit: Adobe Stock Images/JuanGartner.com Obesity is considered a chronic relapsing disease described by adiposopathy, pathogenic changes that can impact multiple systems of the body.1 There is an existing association linking obesity with overall mortality, cardiovascular mortality, and a shorter life expectancy,2 which draws greater attention to how valuable the of implementation of applicable interventions would […]

Image Credit: Adobe Stock Images/JuanGartner.com Obesity is considered a chronic relapsing disease described by adiposopathy, pathogenic changes that can impact multiple systems of the body.1 There is an existing association linking obesity with overall mortality, cardiovascular mortality, and a shorter life expectancy,2 which draws greater attention to how valuable the of implementation of applicable interventions would […]

FDA Approves Lilly’s Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease Kisunla is the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, company says. Semaglutide Associated With Optic Neuropathy That Can Lead to Blindness, Mass Eye and Ear Researchers Report The active ingredient in Ozempic and Wegovy is linked to […]

Image Credit: UPS Healthcare In order for biologics and specialty pharmaceuticals to reach their full potential, it is imperative that the cold-chain logistics process allows products to arrive at the desired temperature and also on time. The importance of this process is brought to light with the fact that 80% of pharmaceutical products in Europe […]

Image Credit: Adobe Stock Images/RadomirJovanovic.com Genezen, a gene therapy contract development and manufacturing organization (CDMO), will be acquiring uniQure’s commercial gene therapy operations in Lexington, MA, which adds a manufacturing plant and a team of employees into the mix.1 Per the deal, Genezen would enter into strategic supply agreements for both uniQure’s clinical portfolio and CSL’s […]

Image Credit: Adobe Stock Images/Gefo.com Based on the presented evidence—including clinical studies showing that it has “equivalent efficacy and comparable safety” as its reference medicine—the FDA has approved Sandoz’s branded biosimilar, Pyzchiva (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection; 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion for subcutaneous injection; […]

Image Credit: Adobe Stock Images/PinkEyes.com Aurigene Pharmaceutical Services Limited, a contract research, development, and manufacturing services organization (CRDMO), will be offering discovery services to Edity Therapeutics Limited in the field of cell therapy.1 According to Edity—a company with various product candidates in the autoimmune disorders, gene therapy, oncology, and regenerative medicine spaces—it has designed a […]

Image Credit: Adobe Stock Images/Png-Jpeg-Vector.com Currently, respiratory syncytial virus (RSV) infection is the leading cause of hospitalization of young children as a result of respiratory complications of apnea, bronchiolitis, and pneumonia.1 Prior to the COVID-19 pandemic, more than two million children 5 years of age or younger in the United States needed medical care for RSV […]

Image Credit: Adobe Stock Images/LoveEmployee.com Veranova, a manufacturer and developer of specialist and complex active pharmaceutical ingredients (APIs) for the pharmaceutical and biotech sectors, has begun to expand its antibody-drug conjugate (ADC) and highly potent compound development and manufacturing capabilities at its Devens, MA facility.1 The FDA-approved site that has over a decade of experience […]

Cellares’ Cell Shuttle. Image Credit: Cellares Cellares, an integrated development and manufacturing organization (IDMO) that focuses on clinical and industrial-scale cell therapy manufacturing, recently revealed that Kite, a Gilead company, will be assessing its automated manufacturing platform, the Cell Shuttle.1 During this “proof-of-concept” evaluation, the data that is gathered will help Kite in determining the […]

Improving the Efficacy of Genetic Medicines Shawn Davis, CEO of Liberate Bio, shares some insights into the world of drug discovery, development, and delivery, as well as process optimization. Experts Discuss Serious Adverse Events for GLP-1 Medications Potential concerns surrounding GLP-include pancreatitis, pancreatic cancer, colorectal cancer, suicide and other phycological effects, and thyroid cancer. Welcome […]

How Pharma Marketers Can Thrive in a Cookie-Less Era David Minkin, President & GM at epocrates, offers his insights into the importance of trust, first-party data, and strategic partnerships in ensuring successful marketing campaigns. Why Consumers are Switching Providers and Payers Loren McCaghy, director of consulting, health and consumer engagement and product insight at Accenture, […]

Pharmacy Deserts & Underserved/Rural Communities In this part of his Pharmaceutical Executive video interview, Michael Abrams, Managing Partner, Numerof & Associates, speaks about the specific challenges that pharmacy deserts becoming a national issue presents for rural and underserved areas. Plus a discussion of which alternative solutions can help ensure continued access to medications for all. […]

Pharmacy Closure Contributors & Long-Term Consequences In this part of his Pharmaceutical Executive video interview, Michael Abrams, Managing Partner, Numerof & Associates, identifies the main factors contributing to closures of pharmacies big and small and some potential long-term consequences for public health if they continue. Public Health Matters: Generative AI and the Future of Pharmacy […]

Image Credit: Adobe Stock Images/PimanKhrutmuang.com In 2001, the Institute of Medicine released a report, Crossing the Quality Chasm, which noted that “timely access to care” was one of the six areas that define quality healthcare.1 Within the United States, history has shown that there is known association between access to cancer care and improved health […]

Image Credit: Novo Nordisk As noted in a recent Pharma Pulse,1 Novo Nordisk plans invest $4.1 billion toward the construction of a second fill-finish manufacturing plant in Clayton, NC, which will expand the company’s efforts in to creating injectable treatments for individuals with obesity and other chronic diseases.2 The 56-acre project is expected to add […]

Image Credit: Adobe Stock Images/VILevi.com The purpose of Medicaid’s 340B Drug Pricing Program is to grant the participating safety-net hospitals and clinics with incentives—in the form of discounts—from pharma companies on certain outpatient drugs, while billing insurers general reimbursement rates. In other words, says the Health Resources & Services Administration, the goal is to “stretch […]

Adobe Stock Images/Preyanuch.com Independent Pharmacy Cooperative (IPC), a group purchasing organization consisting of community pharmacies, has reached a new supply agreement1 with McKesson, a drug wholesaler that’s considered a part of the industry’s “Big Three.” The deal had been about a year in the making, and IPC noted that it helps to empower its member […]

Image Credit: Adobe Stock Images/Grinny.com Hypertension—also known as high blood pressure—is a health issue that impacts close to half of the population in the United States. Given its magnitude, many patients are aware of the daily follow-up appointments with the clinical care team that are needed in order to not only properly regulate medications, but […]

Image Credit: Adobe Stock Images/Ayesha.com Charles River Laboratories International, Inc., a contract development and manufacturing organization (CDMO), and the Gates Institute at the University of Colorado Anschutz Medical Campus have reached a lentiviral vector manufacturing agreement.1 Per the deal, Gates Institute will utilize Charles River’s cell and gene therapy (CGT) expertise—especially in the manufacturing space—to develop good manufacturing practice (GMP)-grade lentiviral […]

Image Credit: Adobe Stock Images/RyanKing999.com ANI Pharmaceuticals, Inc., a biopharma company in the branded and generic prescription sector, and Alimera Sciences, Inc., who operates in the retinal health space, has purchased Alimera for approximately $381 million.1 Per the deal, this equates to $5.50 per share in cash at closing, while also including one non-tradable contingent […]

Image Credit: ProBio Inc. ProBio Inc, a contract development and manufacturing organization (CDMO) that is also known as GenScript ProBio, will be growing its plasmid DNA (pDNA) and viral vector manufacturing services by opening a new 128,000 square-foot plant in Hopewell, NJ.1 This new facility will operate as the hub for all North American operations, which […]

PC: How are changing reimbursement models impacting patient access to therapies in the space? As you know, even if a drug were to make it to market, questions remain as to whether it will be covered by insurance or even added to a national preferred formulary, making it difficult for patients from an affordability perspective. […]

Image Credit: Adobe Stock Images/iDoPixBox.com When it comes to the treatment of unresectable locally advanced stage III non–small cell lung cancer (NSCLC), the standard of care process features definitive chemoradiotherapy, followed by maintenance immunotherapy with durvalumab. In these instances, the obstacle is durvalumab’s cost of use in health systems, along with access, health system approvals, […]

DIA 2024: Gareth Dabbs of IQVIA Discusses Challenges With Clinical Technology In an interview with editor Andy Studna at DIA 2024, Dabbs, vice president, global product strategy, IQVIA highlights challenges with tech overload and how stakeholders can choose which solution(s) are best for their studies. Exploring the Connection Between Orange Peels, Gut Metabolism, and Heart […]

Image Credit: Adobe Stock Images/Nina.com Ascidian Therapeutics, a biotech company, has entered a research collaboration and licensing agreement with Roche for the discovery and development of RNA exon-editing therapeutics that target neurological diseases.1 Ascidian—whose efforts revolve around rewriting RNA—has an RNA exon editing platform that is intended to further the benefits of RNA medicine by […]

The Potential of CAR T Therapies: Q&A with Ying Huang Legend Biotech revealed data collected from the CARTITUDE-2 Cohort D study at ASCO 2024 in Chicago in late May and early June of this year. The study is testing the ability of Carvykti to treat patients with relapsed/refractory multiple myeloma. The company’s CEO, Ying Huang, […]

What the Leaders of the Most Effective Teams Know Findings from hundreds of interviews of exceptional pharma leaders around the world. Global Mortality and Disability from Type 1 Diabetes Have Decreased Global mortality fell 13 times faster in countries with a high sociodemographic index compared with countries with a low-middle sociodemographic index. Improve Site Experience […]

In this exclusive PC Podcast interview, Mark Bouck, chairman and CEO of PharmAlliance, a pharmaceutical and life sciences services platform, dives into: How PharmAlliance’s acquisition of Complete Health Economics Outcomes Research Solutions (CHEORS) helps expand global reach The platform’s biggest goal to when it comes to CHEORS and market access services How CHEORS helps navigate […]

Image Credit: Adobe Stock Images/MPStudio.com Abzena, a contract development and manufacturing organization (CDMO) for complex biologics and bioconjugates, and Argonaut Manufacturing Services, Inc., a current good manufacturing practice (cGMP) CDMO that operates in the diagnostics and biopharmaceutical and diagnostics sectors, have decided to partner up to design a fully integrated drug substance and drug product […]

Image Credit: Adobe Stock Images/iKatod.com As part of the company’s commercial plan, Bora Pharmaceuticals Co., Ltd., a contract development and manufacturing organization (CDMO), will be acquiring Emergent BioSolutions’ 87,000 square-foot sterile manufacturing facility in Baltimore-Camden, MD.1 The current site’s staff will also have the option to join the Bora team if they elect to do […]

Image Credit: Adobe Stock Images/IFoto.com Racial inequalities—and their impact on health outcomes—can be influenced by treatment differences due to a change in clinical practices according to location, implicit bias, limited access to care, social determinants of health, and systemic and historical racism. Over the years, there has been a larger light being shined on how […]

PC: In terms of the approval pipeline, what is coming down the pike? Gregory: As far as biosimilars go in the pipeline, we’re pretty far into it. They’re not new anymore, but I feel like there’s still this big boom happening right now with the adalimumab biosimilars. I previously mentioned adalimumab was very much influenced […]

PC: You had previously penned a byline for Pharma Commerce in which you described how the biosimilars market has experienced massive growth, but regulatory and adoption challenges remain. Could you elaborate further on that? Gregory: Things are moving very quickly in the biosimilars world as they always have been. I think biosimilars are doing very […]

Image Credit: Adobe Stock Images/TylerOlson.com No one would deny that there were various consequences due to the COVID-19 pandemic, including the fact that continuity of care in the cancer space was negatively affected. Many might remember that due to the rapid spread of the SARS-CoV-2 virus, alongside the rise in US death due to the […]

The Healthcare System is Changing—So How Should We Respond? What pharma needs to do to keep up with the rise in value-based care. How Stepped Palliative Care Can Improve Quality of Life for Lung Cancer Patients In a randomized clinical trial, the effectiveness of a stepped-care model for delivering palliative care to patients with advanced […]

Ensuring Responsible and Ethical Use of AI Technology In this part of his Pharmaceutical Executive video interview, Brice Challamel, Vice President, AI Products & Platforms, Moderna, discusses how Moderna is ensuring responsible and ethical use of AI technology within its operations. Coverage for GLP-1 Drugs for Obesity is in Flux | AHIP 2024 Coverage for […]

Weight Loss Drug Shortage Prompts Multiple Companies to Launch Shortage Tracking Platforms Hypermedica and Ro announced platforms to help patients find access to affordable weight loss medications. Building Trust with Patients to Overcome Misinformation | AHIP 2024 Geeta Nayyar, M.D., a rheumatologist and author, discusses how misinformation and disinformation is eroding the trust between doctors […]

PC: You recently penned your first byline, which has appeared in the June issue of Pharma Commerce. What does it discuss? Powers: What I’m doing here in the first write up is really contemplating digital platforms and dynamic pricing models, and what they’ve accomplished in other sectors. And really having an objective look about what it […]

Wacker Biotech, a therapeutic protein contract manufacturer, recently opened up an mRNA competence center at its biotech site in Halle (Saale), Germany.1 The new facility—which broke ground in 20222 and was funded for $107 million—has the capability to handle large-scale manufacturing of active ingredients based on messenger ribonucleic acid (mRNA), including mRNA vaccines to combat […]

Image Credit: UPS Healthcare UPS Healthcare has decided to further grow its European hub facility in Roermond, Netherlands by 235,299 square feet, and will be using that additional space for in-demand freezer farms, which serve as a collection of ultra-low cold storage units that preserve biological samples for long periods, a necessity for a bulk […]

Image Credit: Adobe Stock Images/Pornfa.com In a recent webinar1 hosted by Systech, a provider of digital identification and traceability solutions, and IDC, a market intelligence firm, the speakers were brought together in an effort to address the challenges presented by the pharmaceutical supply chain. Titled “Solving the pharmaceutical supply chain challenges,” moderator Sreedhar Patnala, Systech’s […]

Image Credit: Berkeley Investments Discovery Life Sciences, a provider of biospecimen solutions and laboratory services, is opening a new 53,000 square-foot office and laboratory site in Malden, MA.1 This specific facility marks the company’s seventh facility in the United States—its third in the Greater Boston area—alongside its Woburn and Quincy locations. The Malden plant is intended to directly benefit the pharma and biotech […]

Image Credit: Adobe Stock Images/GraphicRoyalty.com Estrogen receptor–positive (ER+) breast cancer—which is when cancer cells with receptors attach to estrogen—make up more than 70% of all breast cancer diagnoses. Receptors must be found in more than 10% of cancers in order to be considered ER.+ To combat this, the use of endocrine therapy, along with the […]

The creation of the electronic common technical document (eCTD) revolutionized the pharmaceutical regulatory submission process. It enabled the phasing out of paper-based processes, bringing much needed speed, reliability, and efficiency to global regulatory submissions. As the standard format for submitting regulatory applications, supplements, and amendments, eCTD is accepted by health authorities around the world, such […]

A digital rendering of the south facade of Kyowa Kirin’s manufacturing facility. Image Credit: Kyowa Kirin Kyowa Kirin, Inc., a global specialty pharmaceutical company and affiliate of Kyowa Kirin Co., Ltd, will be financially committing up to $530 million for the construction of a new, state-of-the-art manufacturing facility in Sanford, NC.1 With construction expected to begin in the […]

Image Credit: Adobe Stock Images/Wladimir1804.com When it comes to the older adult demographic, there is an association between social service investments—such as income support, nutrition assistance, and housing support—and a decrease in medical care costs and improvements in health. As noted by the authors of a study published in JAMA Network Open,1 medical investments have […]

Pharmaceutical Commerce – June 2024 Issue (PDF) ‘Maturity’ Matters: Fortifying Two Key Cogs of Pharma Supply Chain Dynamic Pricing: What Pharma Needs? Combining RWE and AI to Bend the Adherence Curve Justifying Price Fairness How Serious Are You About Patient Centricity? Medicine for the Planet: Building a Sustainable Legacy in Pharma Supply Chains The Need […]

Mark Cuban Talks Drug Pricing Now more than two years into launching his alternative and transparent drug payment model, the longtime entrepreneur, in an interview with Pharm Exec, discusses the prescription drug cost landscape and shares his recipe for true disruption to the pharma pricing machine. Cost Remains Significant Barrier to Respiratory Care for Patients […]

PC: Could you describe some common pain points in the space that the industry has been experiencing? Cheng: I will build off of what I just mentioned. If you think about patient access, if you think about the regulatory requirements, if you think about market access as it relates to pricing and reimbursement, one of […]

Image Credit: Adobe Stock Images/Iryna.com If the COVID-19 pandemic could be boiled down to one lesson, it is the fact that vaccines played an effective role in limiting the spread of infectious disease. Sure, supply chain issues that impact manufacturing and distribution efforts can occur—alongside length regulatory approval processes—but no process is flawless. Interestingly enough, […]

Rising cost pressures demand more efficient operations. Micro-launches are creating shorter go-to-market runways. The continued rise of specialty drugs with small patient populations puts increased pressure on companies’ promotional efforts. In this landscape, there are many ideas for how to improve commercial focus and effectiveness. However, maximizing the impact of commercial efforts starts with putting […]

Global price comparisons for prescription drugs continue to draw the attention of politicians, medical groups, and patient organizations. WHO and lower-income countries advocate for income-based pricing to address their low levels of affordability. However, higher-income countries systematically use lower prices around the world to lower their prices through international price referencing. Is the US subsidizing […]

It’s widely understood that poor adherence to prescribed medication regimens has far-reaching clinical and cost implications for all healthcare stakeholders. For example, patients who never start or don’t stay on prescribed treatments fail to control their symptoms and often experience disease progression and increased morbidity and mortality. Insurance companies end up paying for expensive medical […]

Image Credit: Adobe Stock Images/JK_kyota.com Inizio Engage, a strategic, commercial, and creative engagement partner that specializes in healthcare, is launching a new global experiential agency, Emota, thereby combining Ashfield Event Experiences (AEE) and WRG.1 The resulting agency is expected to provide a full portfolio of services and capabilities that serve the healthcare industry and global […]

As the benchmark of a successful business, sustainability and being environmentally focused is more than a symbol of advancement and efficiency; it is an absolute necessity for a world facing growing ecological concerns. Modern organizations must remain cognizant of their inefficiencies and their peripheral effects on our planet. To bring sustainability to the forefront, environmental, […]

Image credit: Cagkan | stock.adobe.com The 340B Drug Pricing Program continued to evolve in 2023, and further changes may be forthcoming as a result of ongoing lawsuits and regulatory action. For years, the program has become increasingly controversial, due to a lack of consensus between covered entities1 and pharmaceutical manufacturers over the permissible scope of […]

Image Credit: Bionova Scientific Bionova Scientific, a biologics contract development and manufacturing organization (CDMO) that was acquired by Asahi Kasei Medical,is dipping its toes into plasmid DNA (pDNA) production.1 This endeavor will be centered around a new development and manufacturing facility in The Woodlands, TX, which is close to Houston. Once the plant becomes operational […]

Image Credit: Adobe Stock Images/MonkeyBusiness.com The umbrella term Alzheimer’s disease and related dementias (ADRD) is intended to include Alzheimer’s disease (AD) along with other forms of dementia, vascular contributions to cognitive impairment and dementia frontotemporal degeneration, mixed etiology dementias, and Lewy body dementia. In 2021, it was estimated that more than six million Americans aged […]

Cisterna di Latina, Italy. Image Credit: Adobe Stock Images/ValerioMei.com Stevanato Group, a provider of drug containment and delivery solutions, has officially introduced its Cisterna di Latina plant in Italy.1 The site is located a few miles from the Group’s plant in Latina, and covers an area of 700,000 square feet with about 200 people on […]

PC: Cencora’s ThinkLive Cell and Gene Therapy Summit was an inaugural biopharma event dedicated to exploring the future of cell and gene therapies (CGTs). Could you expound on the goal of this event, and what excites you the most about it? Cheng: At Cencora, we really believe in cell and gene therapy. There’s so much […]

Image Credit: Thermo Fisher Scientific Thermo Fisher Scientific, a contract development and manufacturing organization (CDMO), has opened a new clinical and commercial ultra-cold facility in the EU,1 which not only grows its European clinical trial network, but helps speed up advanced therapy development. The new current good manufacturing practice (cGMP) facility in Bleiswijk, Netherlands offers both […]

Finding Hope with Clinical Trials Nick Slack, CEO and chairman for START Center for Cancer Research, discusses the complications that patients have getting enrolled in clinical trials. Proposed FDA Rule Could Limit Pharmacy Compounding On March 20, 2024, the FDA proposed a new rule that would create criteria for certain drug products or categories that […]

Image Credit: Adobe Stock Images/LeoWolfert.com FourKites, a real-time supply chain visibility provider, will become a collaborator in the Scheduling Standards Consortium (SSC); the company is considered the first participating real-time visibility platform.1 The SSC is intended to “simplify the integration of systems across the fragmented ecosystem between shippers, carriers, and intermediaries, and create a more efficient appointment scheduling […]

FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Financial Burden of Private Healthcare […]

AI in Clinical Trials: A Long, But Promising Road Ahead Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more. Gen Z’s Passion for Skincare Falls Short on […]

As healthcare is moving toward the shared goal of improving patient care more economically, stakeholders across the spectrum are increasingly aligned with the principles of value-based care. This paradigm shift is particularly evident in biopharma, which plays a pivotal role in the American healthcare system’s transformation. As we navigate this transition, the complexity of healthcare […]

Image Credit: Sterling Pharma Solutions Website Sterling Pharma Solutions, a contract development and manufacturing organization (CDMO), is financially committing $3 million toward its Germantown, WI plant, in order to grow its integrated antibody-drug conjugate (ADC) development and manufacturing services.1 This expansion project opens up the door for the recruitment of more scientists, alongside the hiring of a full-time industrial […]

Today’s global marketplace demands robust measures for maintaining both product integrity and adherence to strict regulatory frameworks. Serialization technology is at the forefront of these efforts. This evolving technology—through its sophisticated mechanisms—is enhancing the safety and reliability of products throughout their journey from production to consumer. Below, we’ll explore how advancements in serialization technology are […]

The momentum continues for global air cargo demand—April 2024 data gathered by the International Air Transport Association (IATA) suggests that there has been “strong annual growth” in demand, as the industry continues through Q2.1 Total demand, which is measured in cargo tonne-kilometers (CTKs), increased by 11.1% compared to April 2023 levels (11.6% for international operations). […]

Watch the video and learn more: Critical collaboration points between air freight stakeholders to ensure 100% logistics control. Working with supply partners to use reusable containers vs. single-use packaging. Balancing sustainability and performance when designing thermal packaging solutions for the air freight sector.

Image Credit: Kuehne+Nagel Kuehne+Nagel has opened a new 363,000 square-foot facility in El Paso, TX.1 The plant, which is scheduled to open on Aug. 5, 2024 while also bringing 145 jobs to the area, consists of four warehouses from across the border that are essentially consolidated into one. Nearshoring—the concept of relocating business operations to […]

Image Credit: Adobe Stock Images/Crystal light CG Oncology announced positive final results from its Phase II CORE-001 clinical trial of cretostimogene grenadenorepvec (an oncolytic immunotherapy) in combination with pembrolizumab for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS). Results indicated that at one year, the complete response (CR) rate was […]

A Fun and Insightful Exploration of Behavioral Science Sharing an entertaining dive into the origins, milestones, and future of behavioral economics—where lessons can be applied to clinical practice. A Conversation Veteran Healthcare Lobbyist Paul Kelly | DC Roundtable A limited pharmacy benefit manager (PBM) reform bill may be used as a “pay for” to offset […]

Using an Omnichannel Approach for a Successful Product Launch Inizio’s chief operations officer discusses how pharmaceutical companies are tailoring their product launch strategies to meet the diverse needs of stakeholders. Optimizing Pharmaceutical Innovation Through AI: A Pathway to Expedited Drug Discovery and Development Clinical trials are using AI to handle large and complex volumes of […]

Image Credit: Adobe Stock Images/NewAfrica.com Resource Label Group, LLC, a provider of label and packaging solutions including pressure sensitive labels, pharmaceutical packaging, and radio frequency identification/near-field communication (RFID/NFC) technology, has acquired Beyer Graphics, a specialty pharmaceutical and healthcare packaging business.1 The company’s high-tech plant focuses on providing packaging solutions, including such as custom folding boxes […]

US Pharma and Biotech Summit 2024: The Impact of the Presidential Election Experts discuss how the upcoming election is impacting the pharma industry, and how either party’s victory could change the landscape in the following years. Study Results Find Mood and Sleep Disorders Negatively Impact Asthma Control Despite the finding, the authors suggest further research […]

Mapping Baseline ChatGPT Usage to Support Drug Development Despite limitations to its widespread use within healthcare, there is great potential for ChatGPT’s application in drug development. Multilingual Medicine: A Pharmacist’s Impact on Inclusive Health Care Patricia Gutierrez, PharmD, BCACP, CDE, aims to combat the challenges in culturally competent care with knowledge and love for her […]

US Pharma and Biotech Summit 2024: Bringing the Skillset of Generation Alpha to the Pharma Industry In an interview with Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses new skills that members of generation Alpha will bring to the pharma industry and potential struggles that they may face. Unraveling […]

Leveraging Pre-Approval Information Exchange to Accelerate Product Success, Patient Access Alvana Maliqi, Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. New Biosimilars Continue to be Approved But Uptake Varies by Class A recent IQVIA report found that uptake of […]

MilliporeSigma, a contract development and manufacturing organization that functions as the United States and Canada life science business of Merck KGaA, will be acquiring Mirus Bio for $600 million.1,2,3 Mirus Bio specializes in the development and commercialization of transfection reagents, including TransIT-VirusGEN. When it comes to the production of viral vector-based gene therapies, transfection reagents are heavily […]

Image Credit: Adobe Stock Images/NateeMeepian.com Orna Therapeutics, a biotechnology company that strives to design new classes of fully engineered circular RNA therapeutics (oRNA), has acquired ReNAgade Therapeutics.1 The company’s goal is to a “unlock the potential of RNA therapeutics,” specifically pertaining to delivery that demonstrated to multiple extra-hepatic cells in non-human primate (NHP) models over […]

Aerial view of Discovery Park. Image Credit: Asymchem After Pfizer has previously announced that the facilities would be closing as part of a realignment program, Asymchem Laboratories (Tianjin) Co., Ltd., a contract development and manufacturing organization (CDMO), will now be operating the former Pfizer UK small molecule active pharmaceutical ingredient (API) pilot plant, along with […]

Image Credit: Adobe Stock Images/ColorCrafts.com Biogen Inc. and Human Immunology Biosciences (HI-Bio), a clinical-stage biotech company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), have entered into a definitive agreement under which Biogen will be purchasing HI-Bio for $1.15 billion upfront and up to $650 million in possible milestone payments. As of now, […]

Image Credit: Adobe Stock Images/LeighPrather.com Alongside Cleveland Clinic, TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, will be advancing numerous multivalent universal influenza vaccines into preclinical testing.1 These vaccines reportedly protect against seasonal and pandemic viruses; the choice to send these candidates through into preclinical testing was based on the completion of formulation testing with stability […]

Image Credit: Tower Cold Chain Tower Cold Chain, who was recently interviewed by Pharmaceutical Commerce at LogiPharma Europe,1 has published its first Sustainability Report,2 which outines the company’s pledge to following environmental, social and governance (ESG) principles. The report also lays out the environmental benefits that come with using its passive temperature-controlled containers for the […]

Image Credit: Adobe Stock Images/Funtap.com Astellas Pharma has signed a memorandum of understanding (MoU) with YASKAWA Electric Corporation, signifying early talks to design a cell therapy ecosystem with the use of pharmaceutical and robotics technology.1 Although this particular memorandum is legally non-binding and technically not required to be followed, both parties expect that it will […]

PC: Last week, the FTC voted to ban noncompete agreements that stop employees from working for competitors. How do you think this will affect the pharmaceutical industry in both the short and long term? Lanton: I think it’ll impact smaller businesses that rely on one manager or have smaller operations teams. I think it will […]

Image Credit: Adobe Stock Images/Lial88.com In an $850 million deal, Johnson & Johnson will be acquiring Proteologix, Inc., a privately-held biotech company that specializes in bispecific antibodies for immune-mediated diseases.1 There is also the opportunity for an additional milestone payment. The Proteologix portfolio features PX130, a bispecific antibody targeting IL-13 plus IL-22, which is in […]

Image Credit: Adobe Stock Images/Huenstructurebio.com AstraZeneca will be constructing a $1.5 billion manufacturing facility1 in Singapore for antibody drug conjugates (ADCs)—treatments that provide cancer-killing agents directly to cancer cells through via targeted antibody—which will further boost its current ADC portfolio. Design and construction are expected to begin by the end of this year, with full […]

Post LogiPharma, the editors of Pharmaceutical Commerce examine the trends and highlights that came out of the conference, specifically surrounding the cold chain solutions segment. This digital supplement offers an overview of this niche sector’s value to the industry, and through exclusive video interviews with key opinion leaders and session coverage, provides perspectives from subject […]

Healthcare Marketing Strategies for Reaching Diverse Audiences Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much […]

Leveraging Lessons from Commercialization and Distribution of Rare Products for Cell and Gene Therapy In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses ways that cell and gene therapy developers can follow examples from the commercialization and distribution of orphan drugs. Talkspace Expands Tele-Mental Health to Medicare […]

US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA In an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development. Learning Telehealth Platforms Shows Benefit for Pharmacy Students […]

In this exclusive PC Podcast interview, Chip Davis, president and CEO of the Healthcare Distribution Alliance (HDA), a national organization that represents primary pharmaceutical distributors, discusses: The benefits of the Distribution Management Conference, and the value it provides for the industry A three-year check-in since his last chat with Pharmaceutical Commerce, including a look at […]

Funding pharma and biotech innovation, Financial Times US Pharma and Biotech Summit 2024 It’s no secret that the funding of ground-breaking developments does not come cheap, but where in fact do these aforementioned funds come from? The Financial Times’ US Pharma and Biotech Summit 2024 in New York City carried on with a leaders’ panel centered around […]

Image Credit: UPS Healthcare UPS Healthcare has opened a healthcare logistics facility in Dublin, Ireland, the company confirmed via email. The $13.1 million (€12 million) financial commitment covers over 64,500 square feet and has created 30 new jobs thus far. The plant offers freight forwarding and logistics, small package, and freight forwarding services, which are […]

Image Credit: PharmaLogic PharmaLogic Holdings Corp., a contract development and manufacturing organization (CDMO) and provider of radiopharmacy solutions, has unveiled its radiopharmaceutical production and research facility in the Bronx, NY.1 Purchased in 2022, the facility has been renovated with brand-new equipment, an indicator of the CDMO’s serious interest in long-term radiopharmaceutical investment. “We’re proud to […]

Image Credit: Adobe Stock Images/Rarrarorro.com Sanofi is investing over $1 billion toward the creation of new bioproduction capacity at its sites in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime), and Lyon Gerland (Rhône), all located in France. The new financial commitment is expected to create more than 500 jobs while boosting France’s ability to control the […]

PC: Nowadays, why is there not only a growing importance, but an increasing use of real-time monitoring and digital tools that can mitigate supply chain risks and enable timely deliveries? Porter: We were really excited to launch real time location monitoring last year for all for all customers and all shipments using our multi-use packaging […]

Patient Treatment & Travel: The Need for Stepped-Up Support Drug manufacturers have a long-standing history of providing hub support to help patients navigate the path to product access, effectively utilize their insurance coverage, and understand what other support may be available. But for certain types of therapies, more is needed. The Impact of Medicare Advantage […]

Image Credit: Adobe Stock Images/Hardvicore.com Sharp, a provider of commercial pharmaceutical packaging and clinical trial supply services, will be expanding its Macungie, PA plant in order to boost its production capacity for sterile injectables secondary packaging.1 The Macungie expansion project is expected to provide greater capacity for secondary packaging activities, including autoinjector/pen assembly and labeling; vial […]

Image Credit: Adobe Stock Images/Carl.com Biosimilars—biologic drugs that are biologically similar to their reference products—are often hailed for their potential to offset the high cost of this drug class. They are marketed at purchase prices that are 10% to 40% lower than the cost of the originator, once the originator’s patent expires of course.1 The […]

PC: What technology in the sustainability space are players in the industry adopting? O’Brien: I think we need to do a lot more. When I look at what is here at LogiPharma, and when we look at what’s available on the market, the big focus continues to be the container providers. We see all the […]

Image Credit: Adobe Stock Images/Orkidia.com In an effort to continue expanding on its vaccine development portfolio, Sanofi will be entering into a co-exclusive licensing deal with Novavax.1 Per the agreement, Sanofi will own a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine across the globe (except where Novavax has existing partnership agreements, including […]

Image Credit: Adobe Stock Images/BillionPhotos.com Done., a provider of hybrid care solutions for attention deficit hyperactivity disorder (ADHD) along with other chronic psychiatric conditions, is boosting its pharmacy network to now involve partnerships with more than 30 pharmacies.1 The various collaborations will help better confirm that medication is accessible for all. Such partnerships aim to […]

PC: What specific trends have you noticed the show? O’Brien: There’s a lot of tech developments. It’s probably the first year where I’ve noticed a lot of the innovation is coming from the tech space around digital technology control and visibility. There’s been some cool and innovative tech ideas coming from companies where they’re looking […]

Image Credit: Adobe Stock Images/Mahira.com PCI Pharma Services, a contract development and manufacturing organization (CDMO) and biopharma global outsourcing services provider that currently operates 30 sites across seven countries, has started installing new equipment for what will soon be a 50,000 square-foot, sterile fill-finish facility on its Bedford, NH campus. The installation project features a […]

Image Credit: Adobe Stock Images/NoeySmiley.com Due to the COVID-19 pandemic, the healthcare market had to adjust accordingly to accommodate the shift in use of health services and medications, along with therapeutics and vaccines. Now, with the United States officially ending the public health emergency on May 11, 2023, new trends have come to light for […]

Image Credit: Adobe Stock Images/DeemerwhaStudio.com Veeva, a provider of customer relationship-management (CRM) software to the life sciences industry, updated its customers on the unusual transition it is undergoing as an enterprise software provider. Because it wanted to leave its platform technology originally licensed from Salesforce.com, it announced at last year’s event that it would undertake […]

Image Credit: Adobe Stock Images/JozefMicic.com Myonex, a clinical trial supply company,has now finalized the purchase of Creapharm’s pharmaceutical services business.1 The deal is expected to be beneficial for both pharma and biotech companies in the clinical and commercial stages; this also includes companies in the advanced therapies sector. Moving forward, Creapharm’s clinical packaging and distribution services, commercial […]

Geodis, a transport and logistics company, is continuing to increase its temperature-controlled pharmaceutical shipment capabilities in Europe by being awarded the International Air Transport Association (IATA)’s Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) certification for its Copenhagen location. Including this award, Geodis now has a total of 28 CEIV Pharma certified […]

As a pharmacist, I am privileged to work every day on behalf of clinicians in acute care settings such as hospitals by ensuring medication solutions we provide streamline patient care while easing the demands on doctors, nurses, and other caregivers. One important tool is radio frequency identification (RFID), which can enable hospitals to improve medication […]

Hey Pharma–Do You Know What Your Customers Really Want? Running a healthcare practice is hard, filled with critical daily activities that aren’t covered in medical school. Patients need help with their insurance companies, staff needs help following up with patients—and everyone needs help navigating electronic health records. These pain points offer a prime opportunity for […]

Image Credit: Adobe Stock Images/Ahmad.com Teva Pharmaceuticals and Alvotech, a biotech company that specializes in the development and manufacture of biosimilars, have reached a US strategic partnership agreement.1 Per the deal, Alvotech is set to produce its high-concentration, interchangeable biosimilar to Humira—also known as adalimumab—for Quallent Pharmaceuticals, a private label pharma distributor. In other words, […]

Image Credit: Adobe Stock Images/Catalin.com Xyphos Biosciences, Inc., a wholly owned subsidiary of Astellas Pharma, and Poseida Therapeutics, Inc, a clinical-stage biopharmaceutical company, have inked a research collaboration and license agreement that entails the development of novel convertibleCAR (convertible chimeric antigen receptor) programs.1 This will involve a combination of both parties’ cell therapy platforms. Poseida’s goal is […]

Image Credit: Adobe Stock Images/Kentoh.com Kenco, a provider of third-party logistics (3PL)—which happens to be a major area of coverage for Pharma Commerce—has partnered with QPharma, a cloud-based software company, to add pharmaceutical sample fulfillment to the 3PL’s life sciences division.1 Being heavily involved with commercial pharmaceutical fulfillment, the addition of this sample distribution capability […]

Image Credit: Adobe Stock Images/FormatOriginal.com One of the main purposes of the Inflation Reduction Act (IRA)—which passed in August 2022—is to lower prescription drug prices for Medicare enrollees and taxpayers. However, manufacturers are also incentivized to invest in post-approval activities for both oncology and cardiovascular drugs. In fact, the Medicare Drug Pricing Negotiation Program (DPNP) […]

According to the International Air Transport Association (IATA), March 2024 data for global air freight markets are continuing to present an upward trend, as demonstrated by favorable yearly growth in demand. Total demand, which is measured in cargo tonne-kilometers (CTKs), increased by 10.3% compared to last March’s levels (11.4% for international operations). This represents the […]

The Sygnature Discovery team participating in the “Freezer Challenge.” Image Credit: Sygnature Discovery Sygnature Discovery, a drug discovery contract research organization (CRO), has earned a Bronze rating from EcoVadis, a sustainability ratings platform that assesses companies across multiple industries on environmental, social, and ethical performance criteria.1 In this specific instance, the CRO was acknowledged for […]

Merck KGaA, a science and technology company, will be financially committing more than $322 million (€300 million) into a brand-new, 18,000 square-foot research center at its global headquarters in Darmstadt, Germany. Known as the “Advanced Research Center,” the company’s life science business branch plans on exploring solutions surrounding mRNA applications and manufacturing antibodies, along with […]

Image Credit: Adobe Stock Images/SebastianKaulitzki.com ONO Pharmaceutical Co., Ltd and Deciphera Pharmaceuticals, Inc., a pharma manufacturer focused on cancer medication, has reached a definitive merger agreement. Per the deal, ONO will be purchasing all of Deciphera’s common stock for $25.60 per share in cash via tender offer; this will be proceeded by a merger of […]

Image Credit: Berry Global Group, Inc. In an effort to surge its pharmaceutical production capabilities by as much as 30% across its European facilities, Berry Global Group, Inc., a contract development and manufacturing organization (CDMO) and provider of packaging solutions, is investing in a surplus of assets and manufacturing services. With locations in Offranville, France; […]

Cell & gene therapies—often referred to as CGTs—are continuing to serve as gamechangers within our industry, due to their ability to treat complex diseases. Pharmaceutical Commerce sat down with Wilfredo Marin, senior product application scientist at Thermo Fisher Scientific, to discuss the ultra-low temperature (ULT) storage requirements surrounding CGTs, along with the flexibility for customization. Pharmaceutical Commerce: Could […]

In an effort to further improve patient outcomes while also offering additional value to both payers and partners, Walgreens is launching Walgreens Specialty Pharmacy, a holistic service that aims to expand access to care for patients who have complex, chronic conditions.1 As a result, AllianceRx Walgreens Pharmacy will now become fully integrated, becoming part of […]

Image Credit: Adobe Stock Images/DiomedesDeJesus.com Drug shortages can occur for a plethora of reasons, such as under-reimbursement, quality concerns (i.e., contamination), or natural disasters, but the fact of the matter is that they are becoming more commonplace. These shortages have often been to tied to increased spending, medication errors, missed dosages, and even death.1 As […]

Image Credit: Adobe Stock Images/StoatPhoto.com Riding the momentum of its digital platform LillyDirect that will sell certain drugs directly to consumers with a prescription for conditions such as diabetes, obesity, and migraine,1 Eli Lilly and Company has acquired a Pleasant Prairie, WI manufacturing facility from Nexus Pharmaceuticals, a sterile manufacturer in the pharma sector.2 The […]

Image Credit: Adobe Stock Images/MonsterZtudio.com Kühne Holding AG, the holding company of third-party logistics provider Kuehne+Nagel, has agreed to purchase Aenova Group, a pharma contract development and manufacturing organization (CDMO), from BC Partners, an international investment firm. Although financial terms of the deal were not disclosed, BC Partners’ advised funds are expected to reinvest alongside Kühne […]

Image Credit: Adobe Stock Images/M.Dörr & M.Frommherz The FDA has issued a Complete Response Letter (CRL) in response to Abeona Therapeutics’ Biologics License Application (BLA) for pz-cel (prademagene zamikeracel), a treatment for recessive dystrophic epidermolysis bullosa (RDEB). According to the letter, the agency expressed a need for additional Chemistry Manufacturing and Controls (CMC) information for […]

Covering State Level Legislation and Regulations Impacting Patient Services, Access, and Affordability In this Pharmaceutical Executive video interview, Jon Hamrick, Partner, Curatio Scientia Advisors and Jon Rawlson, President & Founder, Armory Hill Advocates, discuss what’s stopping companies from investing in covering state level legislation and regulations impacting patient services, access, and affordability. Migraine Treatment Comes […]

PC: Supply chain visibility and sustainability are certainly main trends at the show, but what other themes come to mind? Robinson: First, the visibility and sustainability are intrinsically linked. The more visibility that the producers are able to have on their end to end supply chains, the more they’re able to control them, drive efficiencies, […]

Image Credit: Adobe Stock Images/Adin The FDA has approved ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln) for use in combination with Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. According to the company, the approval was based on results from a single-arm, multicenter trial, […]

Image Credit: Adobe Stock Images/Dr_Microbe Expanse ICE announced that its ICE Aspiration System has received 510(k) clearance from the FDA. According to the company, the system treats venous thromboembolism (VTE), which affects nearly one million patients annually in the United States, with 33% experiencing long-term complications. The ICE Aspiration System works by combining proficiencies of […]

Image credit: Coloures-Pic | stock.adobe.com Case management impacts all aspects of a patient’s healthcare journey, from understanding care options and finding the right physician to having a clear picture of the financial costs. But today, case management is more about tracking a patient from one point of service to another rather than having a comprehensive […]

LogiPharma Europe 2024 session, “How can you implement scalable networks to overcome the challenges of complex supply chains for personalized therapies?” April 17, 2024. LogiPharma Europe 2024, Lyon, France. Image Credit: Nicholas Saraceno Cell and gene therapies (CGTs) are becoming more of a focus for Pharmaceutical Commerce, especially given the fact that many of them […]

LogiPharma Europe 2024 session, “How can Diversity, Equity, and Inclusion (DE&I) initiatives within the life sciences supply chain effectively address systemic biases, drive performance and effectively improve innovation, ethical standards, and global healthcare access?” April 18, 2024. LogiPharma Europe 2024, Lyon, France. Image Credit: Nicholas Saraceno Many could make the argument that diversity, equity, and […]

Image Credit: Adobe Stock Images/valiantsin The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, […]

PC: How are changing customer needs and global trends reshaping cold chain logistics? Adamsson: I think there’s several parts of that, especially with terms of global trends. I think we live in a very uncertain world with geopolitical or environmental uncertainty, which means that we as a supply chain industry need to adapt. We need […]

PC: How can data and digital tools help improve visibility and risk management when it comes to cold chain shipping? Adamsson: I think data is the key for the industry moving forward from several dimensions. It’s not only about risk, but about sustainability and cost control. We have to be holistic when it comes to […]

Check out our coverage from LogiPharma Europe 2024 The Real Cost of State Drug Importation Programs? Patient Safety Importing drugs from Canada may increase the risk of US citizens being exposed to unsafe medicines. Talking About the Generations:The health and healthcare of boomers, Gen Xers, millennials and Gen Zers. Part 4, Gen Z. Generation Z […]

Image Credit: Adobe Stock Images/Worldillustrator Genentech announced promising one-year results from the Phase III OCARINA II study, which evaluated Ocrevus (ocrelizumab) in the treatment of patients with both relapsing and primary progressive multiple sclerosis (RMS or PPMS). According to the results, a twice-yearly injection of Ocrevus produced near-complete suppression of clinical relapses and major reductions […]

Check out our coverage from LogiPharma Europe 2024 An Ethical Outlook for Obesity Drugs In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses what to expect from the obesity space in the next five years. It’s Not Just Congress. There’s Plenty of State-Level Action on PBMs, Drug Costs and Prices | AMCP […]

Image Credit: Adobe Stock Images/Stock Pix Novartis revealed promising data from an analysis of its Phase III APPLAUSE-IgAN trial evaluating Fabhalta (iptacopan) in patients with IgA nephropathy (IgAN). According to the study results, patients treated with Fabhalta demonstrated a 38.3% reduction in proteinuria after 9 months when compared to a placebo. The findings were shared […]

LogiPharma Europe 2024 session, “How can you transform digital capabilities in your temperature- controlled supply chain to improve visibility, quality and reactivity?”” April 16, 2024. LogiPharma Europe 2024, Lyon, France. Image Credit: Nicholas Saraceno One of several focuses at this year’s LogiPharma Europe—cold chain—was on full display at a panel discussion titled “How can you […]

Image Credit:Adobe Stock Images/horizor BioHarvest Sciences announced that it has expanded its operations through the signing of a long-term lease for a new 80,000 square foot facility in Yavne, Israel. Additionally, the company purchased equipment for 12 good manufacturing practice (GMP) clean rooms. In total, the lease is expected to cost $5.5 million for a […]

Rare Disease Summit Recap Greater Than One’s Chief Strategy Officer, Andrew Bast, came away from the 2024 Rare Disease Summit in Philadelphia, PA, held this year on March 18th-21st, feeling empowered and inspired. Miranda Schmalfuhs recently connected with him for a Q&A on his experience and what takeaways he found most fascinating and profound. Diabetes […]

Image Credit: Adobe Stock Images/Dr_Microbe NICO Corporation announced that results from the ENRICH trial testing minimally invasive parafascicular surgery (MIPS) technology for intracerebral hemorrhage (ICH) show the procedure is safer than current methods of medical management. The results, published by the New England Journal of Medicine, indicated that early MIPS interventions using the company’s BrainPat […]

The Role of Human Oversight With Artificial Intelligence in Clinical Research Stephen Pyke, chief clinical data and digital officer, Parexel, highlights the importance of human oversight when using artificial intelligence to aid in decision making. Talking About the Generations: The Health and Healthcare of Boomers, Gen Xers, millennials and Gen Zers. Part 2, Gen Xers […]

Image Credit: Adobe Stock Images/XaMaps.com Ascend Advanced Therapies, a gene therapy development partner, has purchased Beacon Therapeutics’ contract, manufacturing, and controls team—along with the company’s site located in Alachua, FL—a town considered to be a “biotech hub” in the state.1 The acquisition introduces a good manufacturing practice (GMP) plant into the fold, along with process and analytical development […]

What Digital Technologies are Being Used to Enhance Clinical Trial Enrollment and Diversity? Systematic review of research articles sought to identify and characterize different technologies being used in clinical studies. 7% of Patients with Cancer Participate in Treatment Research New study finds trial enrollment was highest at NCI-designated cancer centers. Researchers said more needs to […]

Image credit: Africa Studio | stock.adobe.com High inflation and a volatile market have caused a perfect storm for the pharmaceutical industry. How companies respond will make all the difference in not only surviving but thriving in the face of macroeconomic headwinds. Weathering the storm will involve strategies that differ depending on whether you are a small, mid-sized, or large pharma company. The […]

Generative AI-Enabled/Augmented Clinical Trials: The Road Ahead The current clinical development model is shifting toward a generative AI-augmented proactive approach supported by real-world data for real time evidence. Talking About the Generations: The Health and Healthcare of Boomers, Gen Xers, Millennials and Gen Zers. Part 1, The Boomers Tne Boomers (1946–1964): Active but aging Kenvue […]

Image Credit: Adobe Stock Images/Jarun011.com There are more than two million people in the United States who have a chronic hepatitis C virus (HCV) infection, which was also associated with a 400% increase in new HCV infections from 2004 to 2014, a statistic partially attributed to the opioid epidemic. On top of that, in 2019, […]

In this exclusive PC Podcast interview, Allen Jacques, a life sciences industry thought leader at Kinaxis, dives into: What he sees as limitations of current government efforts when it comes to boosting domestic production of essential medicines, and why they aren’t sufficient How and why drug shortages occur The challenges that generic drug manufacturers are […]

Image Credit: Adobe Stock Images/Catalin.com History has shown that the FDA generally approves new drugs to the marketplace that are reportedly “shown to be safe and effective” only if the benefits are greater than the risks.1 Examples date back to the 1980s during the HIV epidemic. At a time when finding a treatment was imperative, […]

Expanding Access to Fight the Obesity Epidemic In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses how access to these weight loss drugs can help the obesity epidemic. Psychedelic Medicine Could Fill Care Gap in Psychiatric Care However, psychedelic medicine has a variety of barriers, including historical perception, access challenges, legal obstacles, […]

Maersk has officially welcomed its brand new 100,000 square-foot warehouse in Wattala, Sri Lanka.1 Vikash Agarwal, managing director, Maersk South Asia; Biju Ravi, head of Maersk Sri Lanka; and Dr Parakrama Dissanayake, deputy chairman & managing director, Aitken Spence PLC, among others, were present for the occasion. According to company officials, the new plant affirms […]

Danial Arkwell, PhD, head of Global Key Accounts, Pharma at Envirotainer. There are approximately 8000 rare diseases in the world and many of these are chronic, life-threatening conditions.1 To fight these elusive illnesses, the medical community focuses on developing specialised medications known as orphan drugs. Originating from the United States Orphan Drug Act (ODA) in […]

Tower’s parcel-sized KTEvolution in the 27 and 56-liter sizes. Image Credit: Tower Cold Chain With the help of ELPRO—a provider of temperature monitoring solutions for the pharmaceutical and life science industries—Tower Cold Chain has launched a new, live tracking feature.1 According to the company, this new partnership is expected to further improve Tower’s advanced passive temperature-controlled […]

The State of AI in Clinical Development In part 1 of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, gives a broad overview of the use of artificial intelligence in clinical development and how regulatory bodies are viewing it. Patient Preferences Play Essential Part in Contraceptive […]

Image Credit: Adobe Stock Images/Aree.com DeSpir Logistics, a third-party logistics provider (3PL) for time-sensitive mission-critical cargo and a “Fast 50 Company,”1 has completed the Healthcare Distribution Alliance (HDA) Good Distribution Practices (GDP) Accreditation Program, making it the first organization to do so.2,3 The program is designed to offer links in the pharma supply chain with the opportunity […]

A Decade of Data Under the Belt In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space. Navigating the Landscape of Cannabis Use in Oncology Despite being a Schedule I drug, cannabis is increasingly […]

In the Wake of the Great Resignation, Can Employees Realistically Expect Any Good Jobs for 2024? A Q&A with Dr. Zeynep Ton, professor at the MIT Sloan School of Management. CMS Finalizes 2025 Rates for Medicare Advantage and Part D Plans Market shares have fallen for CVS, UnitedHealth Group and more following the announcement. How […]

Barriers Impacting Patient Enrollment in Lung Cancer Trials Systematic review of available literature aimed to identify the most prominent barriers affecting enrollment in oncology drug trials. Is 2024 the Year for Psychedelic Medicine? MDMA-assisted therapy and psilocybin currently lead the way with potential approvals by the FDA. Patient With Transplanted Pig Kidney Leaves Hospital for […]

PC: You recently penned your latest byline for the April issue of Pharma Commerce. Without giving too much away, what does it discuss? Schoonveld: The congressional hearings led by Bernie Sanders were a reason to pick up the topic of drug pricing again, which continues to be a big issue in the US. So I […]

Image Credit: Adobe Stock Images/ID_Anuphon.com Logistics4Pharma, a pharmaceutical cold chain packaging, storage, warehousing, and logistics provider that will be exhibiting at this month’s LogiPharma Europe, is growing its services offering at its Kelsterbach, Germany plant by welcoming dry shippers into the fold.1 Dry shippers—also known as cryoshippers—are thermal containers with an inlay that absorbs liquid […]

Image Credit: Adobe Stock Images/ShermanCahal.com McKesson Corporation—one of the drug wholesaling world’s “Big Three”—is launching Project Oasis, which is a new initiative whose goal is to further health equity for at-risk populations that live in underserved communities.1 Project Oasis works to find and draw attention to pharmacy deserts, specifically in urban areas where residents may […]

Image Credit: Adobe Stock Images/ShermanCahal.com McKesson Corporation—one of the drug wholesaling world’s “Big Three”—is launching Project Oasis, which is a new initiative whose goal is to further health equity for at-risk populations that live in underserved communities.1 Project Oasis works to find and draw attention to pharmacy deserts, specifically in urban areas where residents may […]

Not long ago, big data was the big buzz across pharma. It continues to be, though now it’s animating the latest innovation: artificial intelligence (AI). AI is in the news every day via expanded drug discovery, post-market surveillance, earlier and innovative diagnoses, and, well, every part of healthcare, including market access. The large language model […]

As noted by the International Air Transport Association (IATA), February 2024 data suggests that air cargo markets showing are continuing to ride momentum, as demonstrated by the yearly rise in demand. Global air cargo demand, which measured in cargo tonne-kilometers (CTKs), saw an uptick of 11.9%, compared to last February’s numbers (12.4% for international operations). This […]

Pharmaceutical Commerce – April 2024 Issue (PDF) Cold Chain, PBMs, and More Looking Ahead to LogiPharma Europe An ‘Access’ Double-Take: Fresh Views on PAPs and Patient Hubs The Pharma Cold Chain: More Visible, More Sustainable—and Colder The Power of Patient Adherence Tools to Improve the Patient Journey Tackling Patient-Related Challenges Along the Pharma Supply Chain […]

Addressing the needs of the life sciences industry for reliable, cost-effective cold chain solutions remains fertile ground for developing new technologies. Even after a decade or so of advances in insulation, refrigeration techniques, and packaging innovation, new challenges are arising: chief among these are better visibility (via data generation and transmission) of real-time actions in […]

Healthcare journeys vary widely from patient to patient, impacted by unique factors such as age, gender, severity of symptoms, access to specialists, insurance coverage, and more. Amid these complexities, adherence to prescribed therapies emerges as a linchpin for achieving positive health outcomes. However, the healthcare industry continually grapples with persistently low adherence rates, posing a […]