Month: September 2024

Image Credit: Adobe Stock Images/Interstid.com Statistics show that 116 million adults in the United States have hypertension, also known as high blood pressure. There are various modifiable risk factors for cardiovascular disease— smoking, diabetes, high cholesterol, obesity, physical inactivity, and poor nutrition to name a few—but hypertension is considered the top one.1,2 Also, hypertension in […]

PC: Pertaining to the implementation of digital solutions in the marketplace, what kinds of successes have you seen? Mullooly: We’ve seen some great success with implementing these solutions in the marketplace. One example I can share is a manufacturer who decided up front to build a really robust roadmap. They decided to map out exactly […]

Image Credit: Adobe Stock Images/ArtiOm.com In the United States alone, kidney failure affects more than 800,000 individuals, most notably those who are considered low-income and minorities.1-4 Depending on the situation, treatment can require in-center dialysis sessions three times a week, at-home dialysis, or even kidney transplants. Those with kidney failure can qualify for Medicare coverage […]

PC: Could you describe what the Waiver, Exception or Exemption (WEE) request process entails? Gallenagh: So essentially, under the statute, there are different conditions that a member of the supply chain can claim. For instance, if some requirement causes them undue economic hardship—that’s just on example—they can apply for a waiver, exception, or exemption. There […]

Image Credit: Tower Cold Chain Tower Cold Chain and CRYOPDP are partnering up to boost their product offerings to the greater pharma supply chain.1 The agreement among the parties is expected to offer an array of solutions—mainly pertaining to clinical research—in order to address patient needs. The companies are envisioning it as a “one-stop-shop” where customers can a […]

PC: You recently spoke on a panel regarding “Filing Waivers, Exemptions, Exceptions: Lessons Learned – and other HDA Perspectives on DSCSA Implementation and Readiness.” What was discussed during the session, and what questions did the audience raise? Gallenagh: I did the panel—it was myself and also two of my colleagues, Tish Paul from OFW Law […]

Image Credit: Adobe Stock Images/New Africa Results from a pooled analysis of the Phase III SWIFT-1 and SWIFT-2 trials demonstrated that GSK’s depemokimab, a biologic targeting severe asthma with type 2 inflammation, significantly reduces exacerbations of the condition. GSK stated that the treatment is the first ultra-long-acting biologic for asthma to be evaluated in Phase […]

Counterfeit Weight Loss Drugs & Potential Health Risks In this part of their Pharmaceutical Executive video interview, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, and the potential health risks associated with them. The Affordable Care Act: A Strong Card for Harris and […]

Symbiosis Pharmaceutical Services Ltd (Symbiosis), a contract manufacturing organization (CMO), has obtained a new plant in in Stirling, Scotland, UK, doubling the company’s current footprint to 43,500 square feet.1 The CMO notes that the acquisition serves as a boost to manufacturing capacity and bolsters its commercial manufacturing service offering, while accelerating the sterile injectable drug product […]

PC: What advice could you offer pharma manufacturers for implementing these digital solutions within their patient support programs? Mullooly: There are a lot of ways to successfully implement these solutions within your patient support program, but there are three that I think are really crucial, with the first being to know your customer. Know who […]

September 6th 2024 Article Discover a powerful, cost-effective, and robust CRM platform that maximizes your budget. Seamlessly integrate data from any source, streamline marketing efforts, and optimize HCP promotion, key account management, and digital marketing campaigns. Reduce CRM costs and reallocate funds to enhance data analytics, market research, and human capital, boosting overall commercial operations […]

September 6th 2024 Article Discover a powerful, cost-effective, and robust CRM platform that maximizes your budget. Seamlessly integrate data from any source, streamline marketing efforts, and optimize HCP promotion, key account management, and digital marketing campaigns. Reduce CRM costs and reallocate funds to enhance data analytics, market research, and human capital, boosting overall commercial operations […]

September 6th 2024 Article Discover a powerful, cost-effective, and robust CRM platform that maximizes your budget. Seamlessly integrate data from any source, streamline marketing efforts, and optimize HCP promotion, key account management, and digital marketing campaigns. Reduce CRM costs and reallocate funds to enhance data analytics, market research, and human capital, boosting overall commercial operations […]

Validating COAs: Key Steps for Accurate and Reliable Clinical Trial Data With the increasing adoption of COAs, the importance of standardization across training, collection, and implementation to ensure high quality and consistent data collection has become apparent in recent decades. Simplified HIV Treatments Can Lead to Lower Healthcare Costs HIV treatments using a single pill […]

Image Credit: Rentschler Biopharma SE Rentschler Biopharma SE, a contract development and manufacturing organization (CDMO) for biopharmaceuticals, is introducing a new expanded service offering at its dedicated advanced therapies site in Stevenage, UK.1 The enhancement introduces a new lentiviral vector manufacturing (LVV) toolbox, as a supplement to the CDMO’s current adeno-associated viral (AAV) vector services. […]

PC: Following FDA’s ‘s implementation of the stabilization period last year, what is the pharma supply chain’s overall preparedness in adhering to DSCSA’s’ Nov. 27, 2024 compliance deadline? Bernstein: We’re in a good place. It’s not ready 100%, but FDA is implementing this one-year stabilization period, which allowed the supply chain to mature, and the […]

Image Credit: Adobe Stock Images/SagittariusPro.com IntegriChain, a data and business process platform for the pharmaceutical industry, has revealed the lineup of pharma industry subject matter experts that are slated to speak at its annual Access Insights Conference, co-hosted with Blue Fin Group and Federal Compliance Solutions.1 The event will be held Oct. 14-16, 2024, at The Mayflower Hotel, Autograph […]