WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The FDA's inspections may have suffered during the COVID-19 pandemic, but several notable findings still made waves, including for major lapses in emergency vaccine manufacturing and warning letters for repeat violators. Fierce Pharma lists eight of the agency’s most significant citations over the past two years. Meanwhile, J&J said its R&D head Mathai Mammen is heading for the exit, with plans to pursue other opportunities, and Pfizer announced that it would offer patients a money-back guarantee—up to $50K—if its newly approved rare disease drug Panzyga doesn’t do the job. Those stories plus our other top reads of the week follow below. | |
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Featured Story | By James Waldron Johnson & Johnson’s head of R&D is off. In a surprise post-market announcement yesterday, the company revealed that its executive vice president of pharma R&D Mathai Mammen, M.D., Ph.D, is leaving to “pursue other opportunities.” read more |
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Top Stories Of The Week By Kevin Dunleavy Last year Pfizer introduced its first warranty program, using it to promote lung cancer drug Xalkori. Now the company has opened a similar program for newly approved Panzyga, which treats the rare disorder chronic inflammatory demyelinating polyneuropathy (CIPD). read more By Fraiser Kansteiner Given the nature of warning letters and 483s as well as the dangers tied to manufacturing snafus, it doesn't make sense to rank worst offenders. Instead, we're providing a glimpse of FDA write-ups that are significant for different reasons. read more By Annalee Armstrong Merck & Co. is going to be counting coughs and months until the P2X3 receptor antagonist medicine gefapixant is back before regulators. read more By Angus Liu Thanks to a landmark FDA approval, AstraZeneca and Daiichi Sankyo's Enhertu has become the first therapy targeted to treat HER2-low breast cancer. Apparently impressed with the drug's benefits, the FDA is doling out a broad range of use. read more By Gabrielle Masson GSK has paid out $100 million cash to Mersana Therapeutics for the potential to add a second antibody-drug conjugate (ADC) to its pipeline. The new deal encompasses XMT-2056, Mersana’s preclinical ADC aimed at treating a range of HER-2 cancers. read more By Angus Liu The seemingly unstoppable pharma lobbying power has lost its charm. As the U.S. Senate opens the door to a major drug pricing reform with passage of a new bill, the drug industry is licking its wounds. read more By Conor Hale Researchers at MIT have developed a method that could be used to ensure long-lasting diabetes implants do not trigger an immune response, allowing them to keep working without being rejected by the body. read more By Angus Liu In the lead up to Amgen's second-quarter earnings reveal, Wall Street analysts warned that the company's targeted lung cancer drug Lumakras might disappoint in the U.S. It turns out they were right. read more By Angus Liu Past research has faced challenges using bacteria cultured in the lab as therapeutics. Now scientists at the University of California, San Diego have found that native E. coli could be genetically modified to treat chronic disease in the host. read more By Fraiser Kansteiner The potential cancer agent Nitroso-STG-19, also known as NTTP, has surfaced in certain samples of Merck & Co.’s Type 2 diabetes blockbuster Januvia, the FDA said Tuesday. Januvia, also known as sitagliptin, generated $5.3 billion in 2021 and ranked as Merck’s third best-selling drug behind Keytruda and Gardasil. read more By Max Bayer As venture capital pours into budding biotechs, we're launching the Fierce Biotech Fundraising Tracker to keep tabs on all things financing. read more By Teresa Carey This week on "The Top Line," we explore what the landmark drug pricing bill that passed in the Senate means for the industry. We also chat about Pfizer's latest buy and what it suggests for M&A trends. read more Resources Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. | 
