WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Merck had a tough time with its COVID-19 vaccines, plus a major setback with its OncoImmune treatment, but now it’s seeing some good news: working with Ridgeback, their molnupiravir drug helped clear viral infections faster than placebo. Meanwhile, Eli Lilly’s already-authorized antibody combo delivered strong new data, showing it can cut the risk of death or hospitalization from COVID-19 by 87%. But even as vaccines make it into arms across the globe, biopharma companies are looking to the horizon: Pfizer and BioNTech put up their shot against three worrisome mutations of the virus. Our top reads of the week follow below. | |
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Featured Story | By Ben Adams Merck has had a torrid time with COVID-19 vaccines and a major setback with its OncoImmune-partnered pandemic med, but now, finally, it’s seeing some good news on that R&D front. read more |
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Top Stories Of The Week By Eric Sagonowsky Lilly’s COVID-19 antibody combo already boasts an FDA authorization for patients at a high risk of developing severe disease, but now it has even stronger data backing the duo. And it's the best data any coronavirus therapy has delivered so far. read more By Conor Hale,Ben Adams,Amirah Al Idrus,Angus Liu Each member of this year’s class of Fierce 15 stands out in a different way, but they all overcame a year of unforgettable obstacles, making each of their successes much more significant. read more By Eric Sagonowsky As drugmakers respond to the COVID-19 pandemic by developing vaccines and therapeutics, many of them are losing patent protection on older—and once lucrative—medicines. And generics makers are taking the opportunity to seize market share with cheaper copycats. Here's the 2021 list. read more By Ben Adams Johnson & Johnson recently nabbed an emergency use authorization from the FDA for its single-shot COVID-19 vaccine, but today it said its trials for the shot had largely been done virtually through IQVIA. read more By Eric Sagonowsky Vaccine doses are fanning out around the globe, but officials worry that surging coronavirus variants could make the immunization push less effective. Thanks to a new lab study, Pfizer and BioNTech have some good news for them. read more By Arlene Weintraub Researchers at Harvard and Massachusetts General Hospital used a type of artificial intelligence called machine learning to identify existing drugs that might be able to prevent neuronal death in Alzheimer’s disease. The screen pulled up a list of 15 FDA-approved drugs as candidates, including Eli Lilly's JAK inhibitor Olumiant. A clinical trial will start soon. read more By Angus Liu The conclusion from a phase 3 head-to-head trial was clear: Eli Lilly’s dual-action drug candidate tirzepatide is a better diabetes drug than Novo Nordisk's Ozempic. The study may have crowned a new efficacy king, but analysts say Novo can still hold significant market share. read more By Ben Adams If you want Merck to snap you up for nearly $2 billion, all you have to do is play hardball. read more By Fraiser Kansteiner Pfizer recently cited upgrades to its McPherson, Kansas, plant as one of the ways it would double weekly vaccine output in the U.S. by mid-March. But that plant has endured an onslaught of FDA complaints since Pfizer acquired it in its 2015 Hospira buyout, with inspectors citing offenses as recently as last January. read more By Conor Hale The company’s GammaSense therapy was granted a breakthrough designation by the FDA earlier this year, for its goals of reactivating the brain’s immune system and potentially altering the course of the neurodegenerative disease. read more By Eric Sagonowsky GlaxoSmithKline managed to notch some wins during the pandemic-challenged year of 2020, but COVID-19 took its toll—not only on the British pharma's finances, but on CEO Emma Walmsley’s pay, too. read more | | Webinar: Multiple Myeloma Insights from KOL Investigators Tuesday, March 23 | 11am ET / 8am PT / 4pm GMT March Is Multiple Myeloma Month. In recognition of this important month, join us for a Precision Key Opinion Leader (KOL) Insights series webinar. You’ll hear from two leading investigators on the lessons learned, current trends, and insights relevant to the Multiple Myeloma (MM) US and EU research community. Register Now. |
Resources Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: AmerisourceBergen Corporation Unlock product potential by making the most of your commercialization investments. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored by: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. 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. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 