WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Following the success of their mRNA-based COVID shots, it was only a matter of time before drugmakers tried their luck on other diseases. In respiratory syncytial virus, or RSV, Pfizer quietly dropped new data this week showing 100% efficacy against weaker infections after deliberate exposures. Meanwhile, Moderna is not far behind, with fast-track status from the FDA and a phase 1 RSV trial in the works, spanning children to the elderly. Elsewhere, Novo Nordisk’s new obesity drug, Wegovy, is seeing initial U.S. demand outpace supplies, delaying some prescriptions. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Fraiser Kansteiner Initial demand for Novo's new obesity med Wegovy has "exceeded supply" in the U.S., Jefferies analysts wrote in a note to clients Wednesday. That's resulted in temporary delays on the filling of some prescriptions, they said. read more |
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Top Stories Of The Week By Ben Adams Watch out GlaxoSmithKline and Johnson & Johnson, Pfizer is steaming into the respiratory syncytial virus vaccine race in what looks like a late break that could soon become gold. read more By Annalee Armstrong Moderna has its next act lined up: an mRNA respiratory syncytial virus vaccine, which the FDA has just put on the fast track. The biotech, which made its name in 2020 with its COVID-19 vaccine, has been granted a fast track designation for mRNA-1345, which is under investigation as a single-dose vaccine. read more By Fraiser Kansteiner In the pandemic's second year, Pfizer and Moderna's mRNA vaccines largely reign supreme. In new European purchase agreements, the companies are charging more for their doses, The Financial Times reports. read more By Arlene Weintraub A University of Pittsburgh team studied tiny anti-COVID antibodies derived from llamas to determine how effective they might be at fighting emerging variants, including delta. They discovered that the drugs, called nanobodies, can disarm the virus and its variants using any of three different pathways. read more By Fraiser Kansteiner As COVID-19 vaccine production moves full-tilt, mRNA players Pfizer and Moderna are having trouble recruiting talent in Massachusetts. Hiring challenges, which have been exacerbated by the pandemic, aren’t unique to COVID-19 vaccine makers—and they’re not confined to the Bay State either, local business reports and biopharma executives have warned. read more By Nick Paul Taylor Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical trial of its FLT3 bispecific T-cell engager (BiTE). News of the stoppage comes months after Amgen hit pause on a clutch of other BiTE clinical trials. read more By Beth Snyder Bulik Stunning reversals, surprise delays and controversial approvals are the order of the day at the FDA lately—and doctors have had enough. Physicians’ trust in the agency is plummeting, according to a survey by Spherix Global Insights. read more By Angus Liu As Novartis' gene therapy Zolgensma makes inroads in newborns diagnosed with spinal muscular atrophy, the company is looking to expand the drug’s reach to older patients with a new formulation. After a safety scare and a regulatory setback, the Swiss pharma is now back on track with that plan. read more By Andrea Park Building on recent studies showcasing the success of its liquid biopsy tests, InterVenn has now raised $201 million to continue developing its glycoproteomics platform and more diagnostic assays. That marks an exponential increase in its lifetime funding, after previously raising a total of about $45 million across two rounds since 2018. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored by: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule 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: 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. | 