AstraZeneca, Sanofi reveal mixed hand in high-stakes RSV game, with hospitalization miss tarnishing primary endpoint hit As Russia stacked troops on Ukraine's border, Karuna's trial partners got ready Roche plans 4-year late-stage trial for Alzheimer's candidate while awaiting crucial H2 readout Sponsored: The Importance of the Patient in Advancing Care in Rare Diseases Atlas lands $450M fund to build fresh batch of biotechs Avalo adjusts almost entire pipeline weeks after CEO, CFO say sayonara Roche, Sanofi, Novo Nordisk and more pledge support to Ukraine as industry condemns Russian invasion COVID-19, even mild, associated with heart complications up to a year post-infection, study finds AstraZeneca's Alexion wants to make sure rare is still seen and heard 1nHealth, ObvioHealth team to aid firms struggling with decentralized trials Novo Nordisk, citing strong Wegovy demand, doubles 2025 sales target for obesity franchise House Lawmakers eye loan repayments, nursing staff ratios to ease workforce shortages Featured Story | By Nick Paul Taylor There’s more trouble in the respiratory syncytial virus (RSV) race. Days after GlaxoSmithKline stopped its maternal vaccine studies, AstraZeneca and Sanofi have revealed their antibody prospect failed to reduce infant hospitalization in a phase 3 clinical trial. read more |
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Top Stories By Max Bayer When Russia began to stack troops along Ukraine's border—up to 190,000 of them—Karuna Therapeutics' partners began to prepare clinical trial participants for the company's schizophrenia treatment in psychiatric hospitals across the country. read more By Kyle LaHucik Roche is gearing up for a four-year phase 3 study of its Alzheimer's drug gantenerumab, and one trial site in Florida confirmed to Fierce Biotech that patient screening has already gotten underway for the trial, slated to begin June 24. read more Sponsored by: Ipsen Read more to learn about Ipsen's commitment to the rare disease community and to ensuring their patients have a voice. read more By Nick Paul Taylor Atlas Venture has gathered another pot of cash for biotech creation. Less than two years after disclosing a $400 million fund, the Massachusetts-based VC shop has reeled in still more money for its next wave of new startups. read more By Kyle LaHucik Avalo Therapeutics, formerly Cerecor, readjusted almost its entire pipeline Wednesday, just weeks after the biotech's CEO and finance chief hit the exit. read more By Fraiser Kansteiner The contingent of pharma companies condemning Russia’s invasion of Ukraine—and pledging to help keep the beleaguered nation’s healthcare system afloat—is growing. read more By Anastassia Gliadkovskaya Dysrhythmia was the most common individual outcome seen in patients analyzed, and those in ICU were most likely to develop complications across all categories. read more By Sharon Klahr Coey It’s a rather bitter irony that so many people suffer from a rare disease—about 300 million people worldwide. There are around 7,000 different rare diseases, of which sadly only 5% have a viable treatment option. read more By Gareth Macdonald Industry interest in decentralized and hybrid trials is not matched by experience, according to 1nHealth and ObvioHealth, which say their partnership will aid drug developers as they transition to remote and siteless clinical studies. read more By Fraiser Kansteiner Novo Nordisk is gunning for more than 25 billion Danish krone ($3.72 billion) in obesity sales by 2025, the company said Thursday. Novo had previously aimed to generate around 11.35 billion Danish krone (roughly $1.69 billion) by the middle of the decade, based on earlier weight loss med Saxenda’s 2019 sales of 5.7 billion Danish krone ($849 million). read more By Robert King House lawmakers called for several policies to ease a crippling healthcare workforce shortage, including loan repayments and federal nurse staffing requirements. read more Resources Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Fierce BD&L Summit for Life Sciences March 15-16, 2022 | San Francisco, CA Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Pharma PR & Communications Summit West June 14, 2022 | Huntington Beach, CA Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Medical Affairs Strategic Summit (MASS West) September 2022 | San Diego, CA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce New Product Planning Summit November 30 - December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 1, 2023 | 