Category: Medicine

Image Credit: Adobe Stock Images/Neirfy.com In 2021, there were an estimated 537 million people living with diabetes, 90% of whom were living in low- and middle-income countries.1 As a result, it may come as no surprise that this is causing a financial burden on nations’ healthcare systems; in fact, health expenditures surrounding diabetes have actually […]

Many would agree that our inclination toward picking a career is often inspired by some form of epiphany—a realization that a said role is “meant to be.” This is true perhaps even more so in the healthcare sector, where an experience has either directly impacted a person individually, or affected a friend or loved one. […]

Image Credit: Adobe Stock Images/NatalyaLys.com The June 2022 Supreme Court decision surrounding Dobbs v Jackson’s Women’s Health Organization overturned women’s right to have an abortion in the United States, with 14 states enacting total/near-total bans and two additional states enacting six-week bans. Given that this ruling completely altered the legislative landscape, in a cross-sectional, US-wide […]

In this third installment of my “Who Moved My Prescription?” I provide the baseline framework to help manufacturers and pharmacies understand what is broken with retail pharmacy and what to do about it. Just two months ago, we had several key indicators of the state-of-the-state of retail pharmacy and why it is struggling to support […]

PC: Which therapeutics settings, or technology/platform areas, are you seeing the most M&A and partnering activity at the moment? Tritschler: There are several therapeutic areas and technology platforms where we’ve seen a very strong focus in 2023 and the first few months of this year. In terms of TA, oncology is still, by far, ahead […]

The pharmaceutical industry is rapidly approaching a breaking point with its current pharmacy benefit manager (PBM) model. Drug list prices keep rising, and so do required and negotiated rebates. The result is a significant gross-to-net bubble, which reportedly reached $256 billion in 2022.1 Patients continue paying more for drugs, while pharma manufacturers receive low or […]

Fighting for patient affordability doesn’t necessarily require a scapegoat.

Image Credit: Adobe Stock Images/LemauStudio.com Affordable care organizations (ACOs) consist of physicians, hospitals, and other healthcare providers who voluntarily provide care to Medicare patients.1 These ACOs are intended to provide coordinated care, while avoiding not only the duplication of services, but medical mistakes as well. Originally proposed in 2006 and ultimately incorporated into the Affordable […]

In this exclusive PC Podcast interview, Brandon Newman, Xevant’s CEO and founder, explores: The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system The role that pharmacy benefit managers (PBMs) and other intermediaries’ play when it comes to determining drug costs, and how […]

Image Credit: Adobe Stock Images/Diy13.com At its Vaccines Day event, Moderna revealed various clinical and program updates concerning its mRNA pipeline. The company’s vaccine portfolio features 28 vaccines that combat latent, respiratory, and other pathogens.1 When it comes to virus-causing infections, all of these are currently undergoing clinical trials. A latent virus often does not […]

Antibody drug conjugates and cell and gene therapies offer significant therapeutic promise, but their production costs can be sky high. Beyond AI and ML, what other digital tools or innovative manufacturing strategies do you see holding the most promise for reducing costs and increasing accessibility of these treatments? I think the reason in both of […]

As drug discovery and clinical development pipelines accelerate, traditional manufacturing methods are struggling to keep pace. How can biopharma companies leverage cutting-edge digital tools like AI and ML to optimize manufacturing processes and ensure efficient production of novel therapies? Let’s be clear on this, one of the reasons that the industry is challenged as this […]

Image Credit: Adobe Stock Images/ShubbyStudio.com In the United States, one of several public health obstacles is the underuse of care for mental health and substance use disorder (MH/SUD). Unfortunately, some of those experiencing MH/SUD find themselves delaying care due to either a shortage of clinicians or the stigma surrounding mental health. Out-of-pocket (OOP) expenses due […]

Image Credit: Adobe Stock Images/WinNondakowit.com Amazon Pharmacy—riding the momentum of the news that Eli Lilly’s weight loss drug Zepbound can now be ordered via its platform—has debuted its same-day delivery service for prescription medications in both New York City and greater Los Angeles, joining the likes of Austin, Indianapolis, Miami, Phoenix, and Seattle.1,2 Meanwhile, those […]

Image Credit: Adobe Stock Images/Chinnapong.com Diabetes—which impacts how the body uses blood sugar—can cause a variety of different problems, including blindness, cardiovascular disease (CVD), and end-stage kidney disease (ESKD).1 Aside from early detection, preventing these complications often requires controlling CVD risk factors, such as dyslipidemia, hypertension, and hyperglycemia. Tackling these challenges is no simple task, […]

PC: Could you describe the goal of the NAHN? Nava: We actully have two missions. The first one is to increase the diversity of the nursing workforce by creating more pipelines for Hispanic individuals to be interested in a career path in nursing. The second one is to really advocate for the healthcare needs of […]

PC: You recently moderated a presentation on “The State of Patient Access and Affordability.” What was discussed during the session? Niles: Today, the PAN Foundation launched the findings of its annual State of Patient Access report. This will be a flagship advocacy initiative that we launched year over year. The purpose behind this report was […]

PC: How has the Inflation Reduction Act benefited your advocacy efforts? Hoffman: I like to refer to it as the innovation reduction act as opposed to the Inflation Reduction Act. I think there were some unintended consequences in the IRA that are going to have significant detrimental impact on patient populations. The negotiations component of […]

PC: You’ll be a part of the “Ask Me Anything Session with Leading Charitable Foundations” session. Without giving too much away, can you tell us what the session will cover? Green: We will really be talking about where patient assistance organizations stand as of today, also talking a little bit about the trends and how […]

PAP 2024 session, “Collaborating for Patient Assistance Excellence—Insights from Patients, Manufacturers, and Pharmacy Fulfillment Providers.” March 21, 2024. PAP 2024, Philadelphia, Pa. Image Credit: Nicholas Saraceno. Day 3 of Patient Assistance & Access Programs (PAP) was led off by a discussion on “Collaborating for Patient Assistance Excellence—Insights from Patients, Manufacturers, and Pharmacy Fulfillment Providers,” featuring […]

PC: Could you describe PAN Foundation’s main objective? How does the non-profit assist with patients’ out-of-pocket costs? Niles: The PAN Foundation is a national patient advocacy organization and charitable foundation. We are now celebrating our 20th anniversary and at the core of our mission is serving as a very important safety net for people who […]

Image Credit: Adobe Stock Images/Kv_San.com Lonza, a contract development and manufacturing organization (CDMO), will be purchasing Genentech’s large-scale biologics manufacturing site in Vacaville, CA from Roche for a whopping $1.2 billion. The acquisition is expected to close during the second half of 2024, and will be in addition to the $557 million Lonza plans to […]

Check out our conference coverage of Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East UCB’s Women of Childbearing Age Program In this Applied Clinical Trials video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the program’s creation and their most successful strategies for encouraging the […]

PAP 2024 session, “Finding the Silvering Lining—Hear, See, and Feel the Influence of Patient Assistance.” March 21, 2024. PAP 2024, Philadelphia, Pa. Image Credit: Nicholas Saraceno. The final day of Patient Assistance & Access Programs (PAP) spotlighted an individual by the name of Michael Riotto, who has quite an inspirational story which he shared during […]

Check out our conference coverage of Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East Pharmatizing AI Using the 3 Rs to guide AI transformation in Pharma. Should copay accumulators be banned? An increasing number of patients are receiving copay assistance from drug manufacturers and others to help cover the cost of […]

Hubs East 2024 session, “Leveraging Digital Hubs to Improve Retail & Specialty Lite Access, Affordability, and Adherence.” March 20, 2024. Hubs East 2024, Philadelphia, Pa. Image Credit: Nicholas Saraceno. At Hubs and Specialty Models East here in Philadelphia, the event has preached the ease and convenience of digital hubs, which are intended to simplify medication […]

PC: What steps can young innovator companies take to better differentiate their value proposition and attract interest from potential buyers? Tritschler: The early-stage companies are phenomenal in one area—they have a great understanding of the clinical value of their asset. The key problem is not the clinical side of things, but more the commercial and […]

PAP 2024 session, “The State of Patient Access and Affordability.” March 19, 2024. PAP 2024, Philadelphia, Pa. Image Credit: Nicholas Saraceno. Patient Assistance & Access Programs (PAP) featured a session regarding “The State of Patient Access and Affordability,”1 moderated by Amy Niles, chief mission officer at the PAN Foundation, a nonprofit dedicated to helping patients […]

AI’s Impact on CEO/Founder Sustainability In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs. 4 Practical Strategies Healthcare Leaders Can Implement Now to Repel Cyber Attacks Cyberattacks disproportionately affect healthcare organizations. In 2023, the average data breach cost […]

Image Credit: Adobe Stock Images/labden Optinose announced that the FDA has approved Xhance as the first medication for adults with chronic rhinosinusitis without nasal polyps. According to the company, the FDA based the approval on positive data from the ReOpen clinical trial, which evaluated Xhance in this patient population. The treatment utilizes Optinose’s exhalation delivery […]

PC: What’s your feeling on the recent uptick in biopharma M&A and biotech IPO activity as far as influencing and stabilizing prospects for the rest of the year? Tritschler: Many players show interest in M&A and licensing deals. There are large amounts of capital on the sideline ready to be invested. Looking at the numbers, […]

New Technologies Enhancing Transparency Between Patients and Researchers In this Applied Clinical Trials video interview, Julia Lakeland, Chief Product Officer, uMotif, discusses the development of new technologies helping to foster trust and informed decision-making throughout the clinical trial process. Pharmacy Focus: Limited Series: Celebrity Endorsements in Ozempic This podcast episode discussed the impact of celebrity […]

Image Credit: Adobe Stock Images/LeoWolfert.com LSPedia, a provider of software-as-a-service (SaaS) traceability solutions for the pharmaceutical industry, has been granted a national group purchasing agreement with healthcare improvement company Premier, Inc., which means that it will now be providing the company’s network of approximately 4,350 US hospitals and health systems, and more than 300,000 other providers […]

Image Credit: Adobe Stock Images/M+Isolation+Photo.com According to commentary published in the Canadian Medical Association Journal,1 an estimated 33%–40% of patients in Canada have reported experiencing some sort of financial distress following a cancer diagnosis, whether it involves having to drain their savings, concerning themselves over mortgage payments, and going back to work earlier than actually […]

Benefits and Limitations of Strategies Used to Improve Clinical Development Productivity In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings from IQVIA’s Global Trends in R&D 2024 report including the potential benefits and limitations of novel trial designs and decentralized methodologies. Elranatamab Maintains or […]

Image credit: Bernice | stock.adobe.com Global supply chain issues are not exclusive to the pharmaceutical industry. However, this is an industry in which the detrimental effect of supply chain disruptions has not only caused severe chain reactions, but has highlighted the glaring vulnerabilities of the United States when it comes to meeting demand for plant-based […]

Fran Gregory, PharmD, MBA. Vice President of Emerging Therapies at Cardinal Health. More than eight years after the first biosimilar was approved for use in the United States, the market is experiencing a historic breakthrough. Last year, nine biosimilars for Humira (adalimumab) made their highly anticipated debut in the United States. A tenth, Simlandi from […]

Image Credit: Adobe Stock Images/Olivier Le Moal Mirum Pharmaceuticals announced that the FDA has approved Livmarli (maralixibat) for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). Additionally, the company has submitted a supplemental New Drug Application (sNDA) to start a higher concentration formulation of the treatment for label expansion to […]

Image Credit: Adobe Stock Images/DiegoMaravilla.com In order to meet customer demand, advanco, a pharmaceutical track-and-trace solutions provider, is opening an office in Singapore to assist the Asia Pacific (APAC) region, joining the locations in Brussels, Belgium; Cologne, Germany; Istanbul, Turkey; London, UK; San Francisco, CA; Princeton, NJ; Singapore, and Sofia, Bulgaria.1 This decision comes at […]

Robert P. Mauch, PharmD, PhD, Cencora Steven H. Collis will retire as president and CEO of Cencora, shifting to the role of executive chair of the company’s board of directors, effective Oct. 1, 2024. Following that date, Robert P. Mauch, PharmD, PhD, Cencora’s current COO, will succeed Collis as president and CEO. He’ll also be […]

Putting Menopause Medication on the Main Stage In this Pharmaceutical Executive video interview, Jill Jaroch, Senior Director, Women’s Health & Urology Marketing at Astellas, discusses the decision to continue VEOZAH’s presence during the big game, the inspiration and message behind the commercial, and if Taylor Swift played a factor in their decision making Navigating the […]

Groovy Singh, CEO, Bright Green Corporation Pharmaceutical Commerce: Could you tell me about Bright Green Corporation? Groovy Singh: Bright Green was first incorporated in April of 2019, and first made a name for itself by becoming the largest publicly traded company to obtain Drug Enforcement Administration (DEA) Schedule I approval to grow, manufacture, and distribute […]

Diversity in Clinical Trials: The Need to Take Action Gadi Saarony, CEO of Advarra examines the current state of diversity in clinical research. He discusses the need for industry to take more action in making trials more diverse, what regulatory bodies need to do to increase awareness, and how researchers can best reach diverse populations. […]

Image Credit: Adobe Stock Images/KristinaBlokhin.com Incyte has revealed new results from a conducted Phase II study that measured the safety and efficacy of its twice-daily, branded ruxolitinib cream 1.5% (Opzelura) in adult patients that are experiencing Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS). HS is a chronic inflammatory skin condition that can result in […]

Yunu Co-Founders Discuss Improving Efficiency and Accuracy in Clinical Trials Jeff Sorenson and Gael Kuhn, Co-founders, Yunu, talk about ways their company has improved efficiency and accuracy in clinical trials for clients such as NCI designated cancer centers. Guiding Women Within Health Care and the Significance of Self-Development, Improvement The vice president and chief pharmacy […]

Image Credit: Almac Group In order to meet demand for commercial manufacturing, packaging, and peptide production services, the Almac Group, a contract development and manufacturing organization (CDMO), has completed the construction of two new purpose-built facilities at its headquarters in Craigavon, Northern Ireland. The expansion project—a multi-million-dollar endeavor—features significant growth for two of the company’s […]

The Biggest Challenges Facing Broader Adoption of Novel Cell and Gene Therapies In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses the biggest challenges facing the broader adoption of novel cell and gene therapies from IQVIA’s Global Trends in R&D 2024 report. Addressing CAR T […]

Image Credit: Adobe Stock Images/JimGlab.com The US Senate’s homeland security committee has decided to proceed with the approval process for a bill that is intended to serve as a national security measure involving WuXi AppTec, a provider of R&D- and manufacturing-enabling services in the pharma, biotech and medical device industries, and BGI, a genomics company, according […]

What emerging scientific advancements do you foresee having the biggest impact on the future direction of the biotechnology industry? We can’t have a conversation about advancements without mentioning AI and machine learning. This really has the potential to speed up many elements of the drug discovery, development, and manufacturing of medicines. However, I think there […]

Image Credit: Adobe Stock Images/Volgariver.com Many would agree that when it comes to healthcare in the United States, high out-of-pocket costs are a significant challenge to achieving optimal outcomes in patients. Associated with these costs is medical debt and issues paying medical bills. In fact, a study estimated that approximately 17.8% of people had medical […]

What specific strategies can new biotech companies adopt beyond outsourcing to navigate the current funding slowdown while securing the capital crucial for their success? There are so many different ways of doing this. And there’s nothing particularly new about it, because I think I spent 20 years in clinical development, and we were talking about […]

AstraZeneca’s Speke site. Image Credit: Gov. UK AstraZeneca is planning to invest $831 million (£650 million) in the UK life sciences sector. The large investment will be distributed among various efforts within the space. The Big Phama company plans to financially commit $575 million (£450 million) toward its manufacturing plant in Speke, Liverpool for not […]

Image Credit: © Андрей Трубицын | AdobeStock_345374024 Four-Steps to Accelerate Study Start-up Cycles Identifying KPIs, benchmarks, key data points, and an actionable plan are all keys to accelerating study start-up cycles. Air Pollution Linked to Childhood Asthma by Early, Middle Childhood Early life air pollution was associated with increased incidence of childhood asthma by early […]

With the increasing focus on supply chains, how do you see the balance between onshoring and outsourcing evolving in the future of the biotech industry? I guess there’s been a tendency, over recent years to do more onshoring, because of COVID, I think, you know, partly because of supply chain challenges. But also, there have […]

Image Credit: Adobe Stock Images/AkuAku.com In an effort to further progress neurodegenerative disease research, Alamar Biosciences, a precision proteomics company, and ALZpath, a diagnostic solutions provider for the Alzheimer’s disease space, have signed a strategic supply agreement.1 The partnership is centered around the ALZpath pTau217 (phosphorylated tau at position 217) antibody, which the parties describe as […]

Image Credit: Adobe Stock Images/MargJohnsonVA.com The Centers for Disease Control and Prevention (CDC) has reported1,2 that the tetanus and diphtheria (Td) vaccine is currently experiencing limited supply, as a result of one of the major manufacturers of the jab, MassBiologics, deciding to discontinue production of TdVax, which is distributed by Grifols. Up until this point, […]

Image Credit: Adobe Stock Images/Nespix.com The Prange Group, who invests in rising pharma companies, and its affiliate Adragos Pharma, a European contract development and manufacturing organization (CDMO), has officially acquired Fresenius Kabi’s sterile pharmaceutical manufacturing unit Halden, Norway. Although details surrounding the deal were not revealed, this purchase helps grow both parties’ global presence and […]

Image Credit: Adobe Stock Images/DeemerwhaStudio.com Despite ongoing challenges, the current US health insurance sector is being classified as stable and thriving, according to AM Best’s annual market segment report.1 The company notes that the momentum gained from the “overall favorable” performance in 2022 extended into the first three quarters of 2023. Although the rise in […]

PC: Recently, you hosted a webinar on the implications of the Inflation Reduction Act. Can you touch upon the main points of the presentation? Ford: It wasn’t as much of a focus as much as what the latest is on the IRA, but more starting to help a lot of our manufacturer partners understand how […]

PC: How do you believe the IRA will evolve over the next five to 10 years? Ford: There’s a lot of different thoughts out there in terms of where we see IRA going. Do we see several tweets? o we see major changes and overhauls to the law itself? Or do we see it even […]

In this exclusive PC Podcast interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares: A general overview of how the 3PL process works, using his 20-plus of pharma supply chain experience as added insight The factors that manufacturers should consider when selecting a 3PL, along with the array of services that a quality 3PL […]

Image Credit: Adobe Stock Images/LeoWolfert.com Systech, a Markem-Imaje solutions brand that offers brand protection via packaging serialization, has released a rework offering for managing exceptions in the pharma supply chain.1 The solution is expected to help with exception management capabilities, starting from the product line all the way through the supply chain in order to […]

Drug Supply Chain Security Act (DSCSA) compliance requirements took effect on November 27, 2023. The clock is now ticking on a one-year stabilization period (November 2023-November 2024) during which trading partners must work to achieve fully interoperable, electronic tracing of drug products at the package level and verification of saleable returns. With its aims to […]

Image Credit: Adobe Stock Images/Woravut.com Many would agree that the COVID-19 pandemic revolutionized the future of healthcare, which, although being a heavy proclamation, is supported by a mountain of evidence. Healthcare has gone digital, as seen by the use of telehealth and patient portals, which allows individuals to access their health data at any time, […]

Image Credit: Adobe Stock Images/Pixel-Shot.com Amneal Pharmaceuticals, Inc. has entered into an exclusive licensing agreement with Zambon Biotech SA, a chemical pharmaceutical company, for IPX203 in the European Union, United Kingdom, and Switzerland. IPX203 is an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules that treats Parkinson’s disease (PD); the manufacturer is seeking regulatory approval of […]

Image Credit: Adobe Stock Images/MyPhotoBuddy.com Over the past few years, wildfires in the United States have grown in prominence—especially on the West Coast in California, and more recently, along the northeastern Texas panhandle and western Oklahoma. These wildfires can break out naturally, but climate change has been a contributing factor to frequency, duration, and intensity […]

Image Credit: Adobe Stock Images/MonkeyBusiness.com When it comes to what employers are looking for on behalf of their employees, medical benefits, including in oncology, are at the top of the list. A “state of the market” report for 20241 authored by Carrum Health and PwC notes that by 2030, national incidence of cancer in people […]

MDVIP’s “Patient Frustration Index.” Image Credit: MDVIP According to a new survey from MDVIP, 61% of Americans are feeling that the US healthcare system is a hassle, while 53% report feeling it’s trending in an impersonal direction by treating patients more like a number rather than a human being. The nationwide study—which was conducted by Ipsos—used […]

Image credit: TuMeggy | stock.adobe.com. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives […]

Image Credit: Adobe Stock Images/Pixel-Shot.com In the United States, hypertension—also known as high blood pressure—affects nearly half of adults, accounting for approximately 121.5 people (47.5% of the total population). This has resulted in a burden on the healthcare system, with healthcare costs ranging from $131-$198 billion.1 If not properly treated with either medication or lifestyle […]

Image Credit: Adobe Stock Images/Drazen.com Medicare Advantage (MA) plans are often known for creating financial incentives, as the US Centers for Medicare & Medicaid Services (CMS) pays MA plans a monthly, upfront rate that is expected to cover most of the healthcare expenses for plan enrollees, while the remaining amount is kept by the plans […]

Image credit: M.studio | stock.adobe.com Following its approval by the FDA last week as the first drug indicated to treat multiple food allergies in patients as young as 1 year of age, data published in the New England Journal of Medicine (NEJM) demonstrated the ability of Novartis’ and Genentech’s Xolair (omalizumab) to significantly reduce severe reactions to several […]

Image Credit: Adobe Stock Images/Dr_Microbe.com In the United States, atherosclerotic cardiovascular disease (ASCVD) continues to be the leading cause of death, with a high level of low-density lipoprotein cholesterol (LDL-C)—or “bad” cholesterol—contributing to this, especially in patients who have genetic lipid disorders.1 In patients with arteriosclerosis, the blood vessels that transport oxygen and nutrients from […]

© vectorfusionart – stock.adobe.com Pharma Pulse rounds up insights every weekday morning from across health care. Here is the February 23, 2024 edition: Is M&A back in 2024? From PharmExec’s interview with Arthur Wong, managing director of S&P Global Ratings, on the state of the M&A market: “Last year, pharma companies basically stopped M&A, so […]

Image credit: peterschreiber.media | stock.adobe.com The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) submitted by Regeneron Pharmaceuticals and Sanofi for Dupixent (dupilumab) as add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation.1 Data presented at the 2023 American Thoracic Society International Conference and […]

Image Credit: Adobe Stock Images/Chesky.com Fortrea, a contract research organization (CRO), has opened its newly expanded 40,000 square-foot, non-commercial specialty pharmacy, FortreaRx, in Lake Mary, Fla., which is expected to provide various forms of patient access solutions—along with ambient and cold-chain distribution services—across the United States. The specialty pharmacy is licensed in all 50 states and […]

Image Credit: Adobe Stock Images/AndrzejTokarski.com In the United States, healthcare organizations are pushing to vertically integrate various components of the supply chain for efficiency purposes. One prime example of this is between physicians and pharmacy services when it comes to self-administered drugs, as noted by a cross-sectional study published in JAMA Network Open.1 Physician organizations, […]

Image credit: tashatuvango | stock.adobe.com The World Health Organization (WHO) has granted SK bioscience with prequalification (PQ) certification for its typhoid conjugate vaccine (TCV), SKYTyphoid (NBP618). The vaccine—developed through a collaboration between SK bioscience and the International Vaccine Institute (IVI) with support from the Bill & Melinda Gates Foundation—marks the fourth WHO PQ granted to SK […]

Image Credit: Adobe Stock Images/DavidUndderriese.com The healthcare industry often relies on the success of biomedical advances, which peaked exponentially during the COVID-19 pandemic. Now that the public health emergency has been declared as officially over (as of April 2023 in the United States), developments are leveling off and there is plenty of opportunity for innovations […]

Image credit: Tada Images | stock.adobe.com Immune-Onc Therapeutics’ novel therapy IO-202 has been granted orphan drug designation by the FDA to treat patients with chronic myelomonocytic leukemia (CMML).1 The first-in-class, humanized IgG1 antibody is currently being analyzed in a Phase I trial (NCT04372433) both as a monotherapy and in combination with Vidaza (azacitidine) with or without […]

Image Credit: Adobe Stock Images/AfricaStudio.media.com Empagliflozin is a medication indicated for glucose control in patients with type 2 diabetes, but now, a study published in the Journal of the American Heart Association1 explores the drug’s efficiency in not only avoiding hospitalizations caused by heart failure (HF), but in extending and improving quality of life for […]

Image credit: ibreakstock | stock.adobe.com. The FDA has granted Priority Review to Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies. The bispecific antibody was developed to bridge B-cell maturation antigen on multiple myeloma cells that have […]

Arshad M. Khanani, MD, MA, FASRS. Image Credit: Opthea Limited Opthea Limited, a clinical-stage biopharma company that creates novel therapies for the treatment of retinal diseases, including wet age-related macular degeneration (AMD), has appointed Arshad M. Khanani, MD, MA, FASRS, as its chief medical advisor. He currently serves as a managing partner, director of clinical research, […]

Image Credit: Adobe Stock Images/PeterSchreiber.media.com Almirall S.A., a dermatology-focused pharmaceutical company, has entered into an exclusive license agreement with Novo Nordisk for rights to NN-8828. an IL-21 blocking monoclonal antibody. Per the deal, Almirall will now have global rights to both develop and commercialize NN-8828 in the immune inflammatory dermatological diseases sector, along with other […]

Image credit: appledesign | stock.adobe.com. The FDA has approved AstraZeneca’s Tagrisso (osimertinib) for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.1,2 Tagrisso was previously approved as a monotherapy […]

Image credit: adragan | stock.adobe.com. Prescription drug pricing has become a major concern in the United States, with patients and their employer-sponsored health plans facing exorbitant costs even after factoring in rebates. In this article, we delve into the intricacies of the pharmaceutical industry, shedding light on issues related to transparency, consumer behavior, and potential […]

Image Credit: Adobe Stock Images/NewAfrica.com Earlier this week, Masimo announced the FDA clearance of the MightySat Fingertip Pulse Oximeter, representing the first FDA-cleared fingertip pulse oximeter for over-the-counter (OTC) sale directly to consumers without a prescription. According to the company, the new device is equipped with Masimo SET pulse oximetry technology, known for accuracy and […]

Image Credit: DHL Supply Chain DHL Supply Chain, a logistics company that operates within Deutsche Post DHL Group, has made a $200 million investment toward growing its life sciences and healthcare offerings.1 This decision features the construction of new, state-of-the-art warehouse facilities in Pennsylvania and North Carolina, expanding their footprint to over 13 million square feet. […]

Image credit: photon_photo | stock.adobe.com. Researchers are beginning to realize the potential of artificial intelligence to predict the safety and efficacy of drugs across different indications and disease states. In a recent study published by Amsterdam University Medical Center, investigators found that a multimodal machine learning approach accelerated the time in which they could determine […]

Image credit: iDoPixBox | stock.adobe.com. EMD Serono, Merck KGaA’s biopharmaceutical business, scored a traditional approval for Tepmetko (tepotinib) to treat adults with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.1 The oral MET inhibitor was developed to inhibit oncogenic MET receptor signaling that is caused by alterations to the MET gene, including METex14 […]

Image credit: bit24 | stock.adobe.com. Food allergy. Allergic food on wooden background. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy.1 Xolair […]

There is one certainty about health care supply chain in 2024: smart executives will challenge the status quo and think differently about strategy. Fraught with a perfect storm of challenges in recent years—including the highest number of drug shortages in nearly a decade—success going forward will be defined by a laser-focused approach to overcoming logistical […]

Image Credit: Adobe Stock Images/Nobeastsofierce.com Rapid cell proliferation or spreading is a staple of cancer, especially when it is combined with therapeutic sensitivity that can result in DNA replication stress (RS). This issue with tumors lies in their ability to become resistant to medications known as RS-inducing (RSi) agents, also known as chemotherapy. In a […]

Image credit: pixelrobot | stock.adobe.com. The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) have launched an examination into the practices of group purchasing organizations (GPOs) and drug wholesalers—middlemen that the agencies stated may be contributing to ongoing shortages of generic drugs. Both agencies are seeking public comment and information on […]

Image credit: peterschreiber.media | stock.adobe.com. Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) has been granted Priority Review status by the FDA for patients aged 12 years and older with solid tumors that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic, and for whom surgical resection will likely cause […]

Image credit: Matthieu | stock.adobe.com. The FDA has approved Ipsen’s Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (mPDAC). The FDA initially approved an Onivyde treatment combination for mPDAC in 2015 in combination with fluorouracil and leucovorin for patients who experienced […]

Image Credit: Adobe Stock Images/Rost9.com Given the severity of terminal and chronic diseases, the regulatory agencies that are responsible for verifying that novel biotherapeutics are as safe and effective as possible often find themselves under pressure to provide quick public access to these products, noted the authors of an analysis published in Cytotherapy.1 Some could […]

Image credit: diy13 | stock.adobe.com Roche has halted its worldwide license and collaboration agreement with Repare Therapeutics Inc. to develop and commercialize camonsertib (RP-3500). The rights to camonsertib, an oral small molecule Ataxia-Telangiectasia and Rad3-related (ATR) protein kinase inhibitor, now revert back to Repare, who plan to continue development of the agent across tumor types.1 “Camonsertib […]

Image Credit: Adobe Stock Images/Neirfy.com Over the past 20 years, type 2 diabetes—a disease in which the pancreas has trouble creating insulin and converting it to energy—has increased in prevalence from 10% to 13%. As a result, issues related to both acute and chronic diabetes are also on the rise, which often signifies a rise […]

Image credit: Destina | stock.adobe.com. The FDA has granted Fast Track designation to GSK’s novel antisense oligonucleotide (ASO) bepirovirsen to treat chronic hepatitis B (CHB).1 The drug was designed to specifically recognize the RNA used by hepatitis B virus (HBV) to replicate in infected liver cells. Bepirovirsen, a triple action investigational ASO, has been found […]

From April 16-18, the 24th edition of LogiPharma Europe takes place at the Centre de Congrès de Lyon in France. It represents the seventh time I’ve put together the conference agenda—a year-round process that brings together 250 speakers from across the pharmaceutical industry to share their knowledge and insight with 1,500 delegates. Just as it […]

Image credit: Juan Gärtner | stock.adobe.com Samsung Biologics, a contract development and manufacturing organization (CDMO), and LegoChem Biosciences, a biotech company, announced a partnership focused on furthering the development and manufacturing of antibody-drug conjugates (ADCs), specifically targeting the treatment of solid tumors. Per the agreement, Samsung Biologics will provide antibody development and drug substance manufacturing […]

Image Credit: Adobe Stock Images/Jezper.com The generic drug market is expected to show significant growth in the coming years. At least, that’s according to a new study conducted by Technavio, a leading global technology research and advisory company.1 In a press release, the research company detailed the estimated growth, stating that it believes the market […]

Image Credit: Adobe Stock Images/Synthex.com When pharmaceutical companies release new drugs into the market, they can choose to provide patient support programs as a way to facilitate access, boost medication adherence, and overall patient outcomes. This can take shape in the form of training that can be tailored to a specific drug, as well as […]

Image Credit: Adobe Stock Images/DiegoMaravilla.com Resource Label Group, LLC (RLG), a provider of label and packaging solutions including pressure sensitive labels, pharmaceutical packaging, and radio frequency identification/near-field communication (RFID/NFC) technology, is creating a specialty pharmaceutical and healthcare packaging division known as RLG Healthcare.1 RLG Healthcare prioritization will be offering packaging solutions in the form of […]

Image Credit: Adobe Stock Images/Zerbor.com All-cause dementia is growing in prominence across the globe, being estimated to impact 57 million people worldwide, which is predicted to balloon to 157 million by the year 2050. In the United Kingdom alone, Alzheimer’s disease (AD) accounts for approximately 50%-75% of all dementia cases, making it the top cause […]

Cardiac muscle fibers in the myocardium. Image Credit: Adobe Stock Images/JosLuis.com The FDA has accepted the filing of BridgeBio Pharma, Inc.’s new drug application (NDA) for acoramidis, an investigational drug used for the treatment of ATTR-CM.1 Also known as transthyretin amyloid cardiomyopathy, the disease is caused by misfolded transthyretin (TTR) protein getting deposited into the […]

Image Credit: AstraZeneca AstraZeneca will be financially committing $300 million toward a state-of-the-art facility in Rockville, MD, a plant that will be responsible for creating cell therapy platforms in the United States for cancer trials, along with future commercial supply.1 The company is building off the momentum of previous deals made in the cell therapy […]

Pharmaceutical Commerce – February 2024 Issue (PDF) New Year, New Aspirations Access Insights and Information Abound A Look at the Medicare ‘Extra Help’ Program Who Moved My Prescription? Part II The Path for Prescription Drug Sales Peeking Behind the Curtain: The Current State of Pharma 3PLs and Future Outlook A Pharma Pricing and Agreements Primer […]

Image credit: Dr_Microbe | stock.adobe.com The FDA has granted Fast Track designation to an application from BioNTech SE and Duality Biologics Co., for BNT325/DB-1305, a next-generation antibody-drug conjugate (ADC) for patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.1 BNT325/DB-1305 targets trophoblast cell-surface antigen 2 (TROP2), […]

Mesothelial cells in body fluid sample. Image credit: toeytoey | stock.adobe.com The FDA has granted Fast Track Designation to Ultimovacs ASA’s novel cancer vaccine UV1, which is under evaluation in combination with the checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo) to improve overall survival (OS) in patients with unresectable malignant pleural mesothelioma (MPM), including in […]

Image Credit: Adobe Stock Images/SiberianArt.com Merck Animal Health, also known as MSD Animal Health outside of the United States and Canada, has purchased Elanco Animal Health’s aqua business for $1.3 billion in cash. The deal—expected to close by mid-year 2024—features a portfolio of medicines and vaccines, supplements, and nutritionals intended for aquatic species; the acquisition […]

Third-party logistics (3PL) providers are often called upon by pharmaceutical manufacturers to help address the challenges surrounding the movement and distribution of medicines; their importance in helping to simplify the pharma supply chain does not go unnoticed. Pharmaceutical Commerce set out to examine the most relevant trends affecting pharma 3PLs heading into 2024, and explores […]

Image credit: MdBabul | stock.adobe.com The FDA has granted Priority Review status to Adaptimmune Therapeutics’ biologics license application (BLA) for afamitresgene autoleucel (afami-cel) in the treatment of advanced synovial sarcoma. The BLA for the novel engineered T-cell therapy was assigned a Prescription Drug User Fee Act target action date of August 4, 2024.1 “The FDA’s […]

Image credit: Taljat | stock.adobe.com Novartis is terminating its agreement with Allarity Therapeutics, Inc. for the exclusive global rights to develop and commercialize the cancer drug dovitinib due to a material breach by Allarity to keep up with its payments, according to an SEC filing.1 Under the prior name of Oncology Venture, Allarity reached an agreement in […]

Image credit: Peter Hansen | stock.adobe.com Sanofi and manufacturing partner AstraZeneca have announced a new reservation program to address the shortages of the respiratory syncytial virus (RSV) vaccine Beyfortus (nirsevimab-alip) that plagued the 2023–2024 RSV season.1 Beyfortus is a monoclonal antibody that protects against RSV-associated lower respiratory tract disease in newborns and infants under 8 months of […]

Image Credit: Adobe Stock Images/SteveCukrov.com Bringing a potential new drug to market is no simple feat, and it requires years of both research and clinical trials to ensure its safety and efficacy. In regard to the latter, late-stage clinical development often requires that research be conducted and funded by large, multinational pharma companies. However, there […]

Evaluate, a consulting and data intelligence provider for the life sciences sector, releases a variety of reports through the course of a year, and 2023 was no different. In fact, in its annual “World Preview 2023: Pharma’s Age of Uncertainty” report,1 the firm cites that prescription drug sales on a global scale are anticipated to […]

Image Credit: Adobe Stock Images/Shakzu.com In order to reduce the risk of contracting HIV, healthcare providers (HCPs) often prescribe oral HIV pre-exposure prophylaxis (PrEP); however, challenges persist in the areas of adherence, persistence, and uptake, which negatively impact overall PrEP use among at-risk populations. The Centers for Disease Control and Prevention (CDC) estimates that there […]

Image credit: Dr_Microbe | stock.adobe.com Takeda and Protagonist Therapeutics have entered a global license and collaboration agreement to develop and commercialize rusfertide, a potential first-in-class treatment for polycythemia vera (PV), a rare blood disorder. Under terms of the agreement, Protagonist will receive an upfront payment of $300 million, with potential for additional payments based on […]

Image credit: Artur | stock.adobe.com Biogen Inc. has announced it will discontinue the development and commercialization of its controversial Alzheimer disease (AD) treatment Aduhelm (aducanumab-avwa).1 The monoclonal antibody was granted accelerated approval by the FDA in June 2021 as a first-of-its kind therapy for AD, a disease that had not seen a significant approval since 2003.2 The […]

Image credit: pikovit | stock.adobe.com Astellas Pharma announced the submission of a Supplemental New Drug Application (sNDA) in the United States and Japan for the combination of Padcev (enfortumab vedotin) plus Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, this would be […]

Image Credit: Adobe Stock Images/MaxZolotukhin.com One major component of Pharmaceutical Commerce’s coverage revolves around drug pricing in the pharma industry. With drug prices in the United States reportedly being higher than any other nation, it opens the floodgates up to affordability issues that can hinder patients’ access to medication. A study published in The New […]

Image credit: wladimir1804 | stock.adobe.com The FDA has granted Priority Review to a pair of supplemental Biologics License Applications (sBLA) filed by Bristol Myers Squibb to expand the indications of the chimeric antigen receptor (CAR) T-cell therapy Breyanzi (lisocabtagene maraleucel) to include adults with relapsed or refractory (R/R) follicular lymphoma (FL) and R/R mantle cell lymphoma […]

Image Credit: Adobe Stock Images/KimberlyBoyles.com In the United States, the opioid epidemic has been an ongoing crisis taking place over the past two-plus decades that continues to present a significant challenge. As reports have indicated, in 2021, there were a record-setting number of fatal overdoses, more than any previous year. As a result, these data […]

Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 […]

Image credit: Mike Mareen | stock.adobe.com The pharmaceutical industry is characterized by a multitude of products with varying complexities and properties, each designed to improve human health and well-being. However, amidst this diversity, there has been a need for a standardized approach to identifying and documenting medicinal products across the globe. This imperative has led […]

Thom Stambaugh, RPh, President, Specialty and Chief Clinical Officer, Altruix In the past decade, the opioid crisis in the United States has received a lot of attention, inspiring documentaries, books, and pop songs. Increased awareness, along with better tools such as naloxone, more community resources, and a reduced stigma surrounding mental health, show progress in […]

Spikes and valleys in M&A and dealmaking activity have been fairly routine and expected occurrences over the years in the biopharmaceutical sector. Just when they’ll strike, however, and the trajectories triggered as a result, are becoming less easy to pin down these days. That’s due in large part to a wildly evolving and complex operating […]

Image credit: Rasi | stock.adobe.com Glucagon-like peptide-1 (GLP-1) receptor agonists may help lower the risk of developing cirrhosis and liver cancer in patients with type 2 diabetes and chronic liver disease, a new study indicates. The study, conducted by Karolinska Institutet in Sweden and published in the journal Gut, builds on prior research that indicate GLP-1 agonists, […]

Image Credit: Adobe Stock Images/Siphosethu F/peopleimages.com It may come as no surprise that older adults who have multiple chronic conditions (MCC) are major users of healthcare, but perhaps what is more shocking is the fact that this said healthcare could have no specific benefit and could do more harm than good. Using input provided by […]

Image credit: Natalia | stock.adobe.com According to an article published by Reuters, three US residents experienced hypoglycemia last year after using what was believed to be a counterfeit version of Ozempic (semaglutide), Novo Nordisk’s GLP-1 receptor agonist. Additionally, the report stated that one person experienced hypoglycemia as a result of injecting a compounded version of […]

Image credit: Yurii Kibalnik | stock.adobe.com The FDA has approved an expanded indication for Regeneron Pharmaceuticals’ and Sanofi’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in patients aged 1 to 11 years weighing at least 33 lbs. The regulatory action makes Dupixent the first and only FDA-approved medication for EoE specifically in this patient population. The FDA approved […]

Image credit: pongmoji | stock.adobe.com Johnson & Johnson has announced positive results from the Phase IIIb VISIBLE clinical trial for Tremfya (guselkumab) in the treatment of scalp psoriasis. According to the results, the treatment produced major improvements not only in scalp psoriasis clearance, but also to scalp itch reduction and patient-reported health-related quality of life […]

In this exclusive PC Podcast interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into: The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars How he would interpret this “Stabilization […]

Image credit: Tada Images | stock.adobe.com Bristol Myers Squibb (BMS) has completed its acquisition of Mirati Therapeutics, Inc., which is now a wholly owned subsidiary of the company.1 The definitive merger agreement was reached in October 2023, with BMS acquiring Mirati for $58 per share in cash, for a total equity value of $4.8 billion.2 […]

Image Credit: Adobe Stock Images/Fotomek.com Simply put, generic drugs are encountered daily at one’s local pharmacy, and are known to have the active ingredients as original drugs; the only difference is the lack of a brand name. The FDA has, in fact, confirmed this, being that agency requires that generics must be identical in terms […]

Image credit: catalin | stock.adobe.com Last week, NK CellTech Co., Ltd announced that the FDA officially granted clearance for its clinical trial for NK010, a non-genetically modified natural killer (NK) cell therapy. According to NK CellTech Co, the therapy is the first non-genetically modified NK cell derived from allogeneic peripheral blood cell (PBMC) developed by […]

Image credit: AIGen | stock.adobe.com CARsgen Therapeutics Holdings Limited, an organization working with chimeric antigen receptor (CAR) T-cell therapies for the treatment of hematologic malignancies and solid tumors, provided an update on its study of satri-cel (satricabtagene autoleucel, CT041) at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The data includes […]

Fran Gregory, VP of Emerging Therapies, Cardinal Health What are some of the recent trends in the cell and gene therapy space? This is an area that is evolving rapidly, a lot of things we’re starting to see coming out in this space, really starting out with the first car-T cell therapies in 2017. This […]

Image credit: suyujung | stock.adobe.com In the first year of our “Prescription for Better Access” podcast, our guests have represented on-the-ground stakeholders who have shed light on the stark paradox that underpins the drug access dialogue: in an era of unprecedented scientific breakthroughs, affordability and access are concurrently deteriorating. In episode 4, health economist Dr. […]

Image credit: Design Cells | stock.adobe.com Phase III trial data for Novartis’ Lutathera (INN: lutetium [177Lu] oxodotreotide/USAN: lutetium Lu 177 dotatate) show first-line therapy with the drug plus long-acting release (LAR) octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive (SSTR+) well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) […]

Nicholas Saraceno: What may be the potential driving force behind recent moves by PBMs like CVS and Express Scripts to overhaul their drug pricing structures? Roth: There’s a lot of speculation on the real drivers behind what these plans really mean. We’ll unpack them in two main ways. One is the rise of the cash […]

Image Credit: Adobe Stock Images/ValeriLuzina.com There has been a long-standing debate as to what the profit motives for the US healthcare system are. Is it greed or is it purely for the love of helping patients, with no strings attached? A recent study published by The New England Journal of Medicine (NEJM) explores the role […]

Image credit: Matthieu | stock.adobe.com The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients with metastatic urothelial carcinoma with […]

Image credit: Vitalii Vodolazskyi | stock.adobe.com Utility Therapeutics, a UK-based biotechnology company, announced that the FDA has granted priority review to its new drug application (NDA) for pivmecillinam, a European-approved treatment of uncomplicated urinary tract infections (UTIs).1 According to Medscape, UTIs occur far more frequently in women, with 20% having at least one in their […]

Nicholas Saraceno: Do you believe the news of Eli Lilly’s digital platform will cause a shift in manufacturers bypassing middlemen to offer DTC sales of Rx drugs via telehealth options? Roth: We talked about it across our entire company on our regular weekly meeting. We view this as more systematic of a number of different […]

Image Credit: Adobe Stock Images/9dreamstudio.com The US pharmaceutical supply chain is an extensive one, with drug wholesalers, manufacturers, distributors, and dispensing pharmacies comprising only a few of its various links. As noted by a commentary published in JAMA Health Forum,1 in 2013, Congress passed the Drug Supply Chain Security Act (DSCSA) as a component of […]

Image credit: Chinnapong | stock.adobe.com The FDA has approved Takeda’s HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). HyQvia, the only subcutaneous immune globulin infusion that can be administered once monthly, […]

Image Credit: Adobe Stock Images/Vasyl.com The use of artificial intelligence (AI) is transforming care for breast cancer, which has the highest incidence rate and the second-highest mortality among all cancers. As such, early detection is a vital first step in breast cancer management, as routine screening tests increase the probability of successful treatment. A report […]

Image credit: chaphot | stock.adobe.com Arcutis Biotherapeutics recently shared significant findings from a pair of clinical trials showing the efficacy of Zoryve (roflumilast) for the treatment of dermatologic conditions at the 2024 Winter Clinical Dermatology Conference in Hawaii. According to the results of one trial, patients administered Zoryve topical foam, 0.3%, for seborrheic dermatitis who […]

According to data released by the International Air Transport Association (IATA) for November 2023, air freight numbers point to the strongest year-on-year growth in about two years. This is not only attributed to weakness in November 2022, but also a fourth straight month of rising air cargo demand. Global demand for air cargo, measured in […]

Image Credit: Adobe Stock Images/Alexej According to a new report by Roots Analysis, the global pharmaceutical contract manufacturing market is anticipated to be worth $140 billion at the start of the next decade. Additionally, it is expected to grow at a rate of 6.5% during the forecast period of 2022-2030. Due to the challenges and […]

Image Credit: Adobe Stock Images/Catalin.com ixlayer, a B2B patient experience platform that offers end-to-end patient diagnostic testing, has become a member of the Innovators’ Network at the American Heart Association Center for Health Technology & Innovation. The Innovators’ Network is a healthcare technology consortium that brings entrepreneurs, providers, researchers, and payers together. Members have access to […]

Image credit: AIGen | stock.adobe.com The FDA has granted clearance to Neuralace Medical’s Axon Therapy, which is a noninvasive treatment for chronic pain related to nerve damage caused by diabetes, known as painful diabetic neuropathy (PDN).1 Axon Therapy utilizes a pioneering approach of magnetic peripheral nerve stimulation (mPNS) to deliver a quick, painless, and non-invasive […]

Image credit: Dr_Microbe | stock.adobe.com The US Department of Defense (DoD) has awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all branches of the US military with BioThrax (Anthrax Vaccine Adsorbed) for use as pre-exposure prophylaxis (PrEP) for anthrax.1 The deal with the DoD, led by the Joint Program Executive Office for Chemical, […]

Image credit: tadamichi | stock.adobe.com Given the importance of reimbursement to any pharmaceutical brand, comprehensive reporting and analytics must be available for any brand to meet the two goals of reimbursement-directed marketing: Gain or maintain reimbursement positions that enable achievement of brand’s objectives. Maximize sales – given achieved reimbursement positions (e.g., pull through). This article […]

Image Credit: Adobe Stock Images/9dreamstudio.com Glucagon-like peptide 1 receptor agonists (GLP-1s) have been a staple of the pharmaceutical industry for several decades now—with the first FDA approval of exendin-4 dating back to 20051—so one might not be surprised that many employers have been covering these types of drugs (for the treatment of diabetes) for quite […]

Image credit: blueringmedia | stock.adobe.com The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate (ADC) RC88 to treat patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.1 Patients diagnosed with aggressive late-stage ovarian cancer experience high expression of mesothelin and have limited treatment options for the […]

Image credit: THITIPORN | stock.adobe.com The FDA has accepted Lantheus Holdings, Inc’s abbreviated new drug application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), which is a generic formulation of lutetium Lu 177 dotatate (Lutathera). The treatment is indicated for adults with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.1 Following the […]

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid […]

The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given […]

At the 42nd annual JP Morgan Healthcare Conference, Moderna said new product launches later this year will return the company to sales growth in 2025. Sales of Moderna’s COVID-19 vaccine dropped from $18.4 billion in 2022 to $6.7 billion in 2023, which was ultimately above projections, the company announced in a business update presented at […]

Review article explores the latest developments surrounding expression and purification strategies. With infection viruses—such as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and influenza—increasing in prominence, it has brought to light the importance of continuing to find effective and quick options to biomanufacture recombinant vaccine antigens at large scale. In fact, a review article published by Frontiers […]

Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer. Merck’s robust oncology and hematology pipeline continues to advance with the launch of pivotal Phase III trials for four novel candidates for hematologic malignancies and solid […]

In the midst of being approved for commercial manufacturing of Pluvict, the 70,000 square-foot site was built specifically to accommodate RLT production. Novartis has received approval from the FDA for commercial manufacturing of Pluvict (lutetium vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis. The 70,000-square foot site, the company’s second […]

Electronic health record messaging network found to improve communication and lead to better medication adherence. According to the Joint Commission, miscommunication and teamwork failures among healthcare professionals (HCPs) are significant causes of sentinel events;1 in fact, they cost US hospitals an estimated $12 billion in 2010.2 To counteract these charges, information technology can be used to […]

Cretostimogene grenadenorepvec is a novel, intravesically delivered oncolytic immunotherapy under evaluation for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the […]

How pharma companies can be successful in financial forecasting, including why these forecasts should be powered by a patient-based approach. In order for pharmaceutical companies to grow in a competitive marketplace, they need to be able to look ahead, anticipating the trends and developments that will shape their business strategy going forward. Some may say […]

Study examines the parallels between doctorate students and the US population. One concern that has been consistently raised in the healthcare professional community is whether or not the race, ethnicity, and sex diversity of students in US health professions programs is an accurate representation of the age-adjusted population. In fact, it was determined that it […]

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers. AstraZeneca had a busy holiday season as it reached a definitive agreement to acquire Gracell Biotechnologies Inc. in a deal that could potentially reach up to $1.2 billion. The acquisition of Gracell, a […]

The latest move expands the company’s storage capacity and cold chain capabilities. Cencora’s World Courier, a specialty logistics provider, intends on opening transport stations in three new markets in the United States, growing its presence and capacity to provide services to the specialty pharmaceutical market.1 The transport stations will be located in Denver, Indianapolis and […]

Bayer executive talks Enable Holistic Hub and Provider Services panel. In an interview with Pharma Commerce editor Nicholas Saraceno, Spencer Miller, Director, Market Access, Trade and Payer, Bayer, previews the Enable Holistic Hub and Provider Services session. Pharma Commerce: Based on your panel discussion, what is the importance of patient and provider access and support […]

The seminar examines where members of the pharma supply chain stand in terms of preparation, being that the act has officially been enacted. One of yesterday’s Trade & Channel Strategies presentations on the “Supply Chain and Distribution Operations” track featured a traceability theme in the form of “The State of DSCSA and Serialization” presentation. Hosted […]

MAPS Public Benefit Corporation was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission of the psychedelic treatment for post-traumatic stress disorder. MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the FDA in what would represent the first approved psychedelic […]

Pfizer said that the addition of Seagen to its current operations could add more than $10 billion in risk-adjusted revenues by 2030. Pfizer Inc. has cleared all regulatory hurdles to complete its $43 billion acquisition of Seagen Inc., which is expected to be completed this week, the company announced in a press release. The waiting […]

The conference hosts a diversity, equity, and inclusion (DE&I) Summit featuring personal insights and experiences. Day 3 of the Trade & Channel Strategies conference in Philadelphia continued its momentum with a DE&I Summit featuring Danielle Helm, area business leader within Novartis’ oncology department, whose career in the pharma and biotech space spans 24 years. Helm […]

Pharma Commerce: What are the keys to successfully navigating what you describe as “the coming perfect storm” in healthcare? Trombetta: The coming perfect storm is broken into three parts. First, there’s the transition of healthcare delivery from volume based care to value based care. Volume based care is based on the healthcare provider, whether it’s […]

Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends. The most-viewed articles in the manufacturing and packaging space add plenty of value, due to their ability to intersect other areas in the pharma space, whether it be regulatory developments or product commercialization. Below are the top 3 manufacturing and packaging […]

Eflornithine (Iwilfin) is indicated to lower the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who showed at least a partial response to previous multi-agent and multimodality treatment that included an anti-GD2 immunotherapy. The FDA has approved eflornithine (Iwilfin) to lower the risk of relapse in adult and pediatric patients with high-risk […]

Over the past year, Pharma Commerce’s digital coverage featured a variety of subject matters, ranging from how to calculate 340B prices, to the future of pharmacy. Pharma Commerce continuously aims to attend as many conferences in the space as time would allow for—this year, that included (but was not limited to) PAP, LogiPharma Europe and […]

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers. The top 3 pieces related to the supply chain—a Pharma Commerce staple—included the key questions and considerations for drug manufacturers pursuing an effective alternative distribution model, how embracing collaboration is key to the battle against RSV, and why companies’ […]

Partner for Archbow Consulting discusses the conference, the IRA, and specifics of PAP business rules In an interview with Pharma Commerce editor Nicholas Saraceno, Douglas Bock, Partner, Archbow Consulting, discusses his breakout session and other key factors of the Trade & Channel Strategies conference. Pharma Commerce: Which trends at Trade & Channel Strategies have caught […]

Items in this sector ranged touched on topics such as pharma shipping, container technology, and sustainability. At Pharma Commerce, cold chain transportation and storage has and continues to be a major area of coverage. Being that it is such a niche category, there is a bit of overlap between topics within the space—focus points include […]

MoU aims to align the pharmaceutical and cold chain sectors by boosting operations. Pharma.Aero—a link that provides the safe transportation of medicine, cures, and vaccines from manufacturing plants to patients—has entered into a memorandum of understanding (MoU) with the Cool Chain Association (CCA), an industry association that specializes in temperature-controlled logistics. The MoU—which is intended […]

This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance. With 10 episodes having gone live this year, The Pharmaceutical Podcast featured interviews with thought leaders from various sectors within the pharma industry, including Drug Supply Chain and Security Act (DSCSA) compliance, maintaining data privacy, and the benefits of drug safety platforms. […]

Cloud-based service to address verification of saleable returns under the latest DSCSA regulations. In the midst of the latest Drug Supply Chain Security Act (DSCSA) regulations, ACG Inspection, a track-and-trace solutions provider for the pharma industry, has launched its new cloud-based verification router service (VRS). The new system, which is part of ACG’s Inspections Life […]

Moderna previously filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 years and older. The results of a pivotal Phase III trial show favorable clinical safety and efficacy data for Moderna’s investigational respiratory syncytial virus (RSV) vaccine mRNA-1345. In findings published […]

If the FDA approves garadacimab, it would be the first approved hereditary angioedema therapy that targets activated FXIIa. The FDA has accepted a Biologics License Application (BLA) for CSL Behring’s garadacimab (CSL312), a once-monthly prophylactic therapy for hereditary angioedema (HAE). A Marketing Authorization Application (MAA) filed by CSL Behring was also accepted by the European […]

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older. The FDA has approved Chiesi Global Rare Diseases’ topical gel Filsuvez (birch triterpenes) to treat partial thickness wounds associated with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). The regulatory action makes […]

Camille Lee discusses the impact of commercial availability of Bimzelx for the treatment of moderate-to-severe plaque psoriasis in adults, along with the value of patient assistance/affordability programs. In this PC Podcast interview that originally aired for Pharmaceutical Executive, Camille Lee, UCB’s SVP and US head of immunology, dives into: The history behind UCB’s work in […]

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental […]

In the face of chronic disease, DTx have the opportunity to provide a lifeline to patients. The world’s population is aging. In the United States alone, the number of people aged 50 and older is expected to increase by more than 60% by 2050.1 And of that older population, the number with at least one […]

A panel designs a conceptual framework in an effort to limit partiality. Healthcare algorithms are designed to use mathematics not only to help boost decision-making abilities but improve health outcomes in the process. Despite these well-intentioned efforts, history has shown that algorithmic bias has plagued minorities in banking, education, and housing sectors, and the same […]

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis. The FDA has approved an expanded indication for LEO Pharma’s Adbry (tralokinumab-ldrm) for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies […]

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive […]

Jemperli has shown potential both as a monotherapy and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial […]

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024. The FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve (roflumilast) topical foam, 0.3% to treat seborrheic dermatitis in patients aged 9 years and older. The once-daily, steroid-free foam is the first approved treatment for […]

The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared Welireg to Afinitor for the treatment of advanced RCC that has progressed after prior treatment with PD-1/L1 and VEGF-TKI therapies. The FDA has approved Merck’s Welireg (belzutifan) for the treatment of adults with advanced renal […]

Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their fullest potential. It’s no secret that staying competitive requires businesses, regardless of industry, to evolve, grow, and innovate. It’s a fact that the global pharmaceutical industry is not immune to. Research from McKinsey shows that […]