WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Janet Woodcock, the FDA’s interim commissioner, has requested an independent investigation into the agency’s decision to approve Biogen’s Aduhelm—echoing calls from physicians, advocates and lawmakers alike. However, Woodcock said she has “tremendous confidence” in CDER’s leadership, and that the probe would ultimately help ensure confidence in the agency’s decision-making. Meanwhile, J&J’s COVID shot faces another setback, with a new FDA warning for a rare risk of the nerve disorder known as Guillain-Barré syndrome. Those stories, plus the top 15 blockbuster drug patent expirations coming this decade, follow below. | |
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Featured Story | By Noah Higgins-Dunn The FDA’s interim commissioner, Janet Woodcock, M.D., requested the Office of Inspector General conduct an independent investigation into the regulator’s approval of Biogen’s Aduhelm, including reports of its cozy relationship with the drugmaker ahead of its decision. read more |
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Top Stories Of The Week By Nick Paul Taylor Novo Nordisk has struck a $1.2 billion deal to buy Prothena’s ATTR amyloidosis program. The deal will see Novo pay $100 million in upfront and near-term fees for worldwide rights to the phase 2 ready anti-amyloid immunotherapy PRX004. read more By Noah Higgins-Dunn Looking out over the next decade, some of the biggest drugs in the industry will tumble off the patent cliff, putting pharma giants in the hot seat as investors clamor for their next blockbuster. Every drug has a different story, Moody's analysts warn, and it's likely some will keep fighting off copycats for as long as they can. read more By Eric Sagonowsky Johnson & Johnson’s COVID-19 vaccine has encountered numerous setbacks ranging from manufacturing issues to an emergency safety review. Use of the vaccine hasn't met initial expectations as a result, and now authorities are reportedly set to highlight an additional concern. read more By Amirah Al Idrus After a year in the shadows, Prime Medicine is breaking cover with $315 million to develop a new kind of gene editing. The company likens its approach to the “search and replace” function on a word processor, with the ability to correct disease-causing mutations without making double-stranded breaks in the DNA. read more By Conor Hale Abbott is letting go 400 full-time employees at its locations in Westbrook and Scarborough, Maine, which focus on producing rapid antigen tests, a local TV station reported. The job cuts follow an unexpectedly steep dropoff in demand for the tests as COVID-19 vaccination continues and infections decline. read more By Angus Liu AbbVie’s top job centers on developing new sources of revenue out of the fear that biosimilars to its megablockbuster Humira will cause a precipitous sales decline starting in 2023. But after analyzing prior cases, one team of analysts believes Humira might experience a more graceful fall than pharma watchers currently expect. read more By Beth Snyder Bulik Neurologists are thinking about Biogen’s newly approved Alzheimer’s drug, but so far it’s mostly just that—thoughts. While almost 90% of neurologists are moderately or highly aware of Aduhelm, only 3% have written prescriptions so far, according to Spherix Global Insights latest data. Even more concerning? Only about one fourth (27%) plan to prescribe the drug in the next few months. read more By Ben Adams After a successful data hit at the start of spring, a new CMO and a jump in stock price, Humanigen is starting the summer with the U.K.'s drug regulator accepting its COVID hopeful lenzilumab for review. read more By Arlene Weintraub University of Pennsylvania researchers delivered a base editor to prenatal and postnatal mouse models of Hurler syndrome, a genetic, lysosomal storage disease that causes organ swelling, muscle abnormalities, heart disease and a range of other problems. They say the results offer proof-of-concept for correcting some genetic disorders before birth. read more By Fraiser Kansteiner Curia, the CDMO formerly known as Albany Molecular Research, said Tuesday it was buying California-based Integrity Bio in a move that will see its formulation and fill-finish services stretch to the West Coast. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. 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Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. |
