AstraZeneca axes Moderna-partnered, phase 2 heart disease drug plus a Wee inhibitor Sarepta shares buoyed by pledge to seek an early swift review for Duchenne gene therapy Pfizer undeterred in CD47 plans as competitors face pitfalls Sponsored: Unlocking the power of AI-driven pathology in drug development: An Interview with Bristol Myers Squibb FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should 'move into a new phase' Onwards! Novo Nordisk's once-weekly insulin marches on after hitting goals in pair of phase 3 trials The shape of things to come: DeepMind’s AlphaFold illuminates 3D structure of almost every protein known to science Biogen deflects claims it misled shareholders about Aduhelm's success Bausch + Lomb kicks off TikTok challenge for Lumify, asking consumers to 'dance with their eyes' 'The Top Line' podcast: Lessons from Alzheimer's failures, is pharma doing enough for the climate, plus more Biden admin to insurers: Don't cut off birth control coverage Chutes & Ladders—Amgen vet to be CMO at KRAS-driven Affini-T Fierce Pharma Asia—Takeda's cancer drug woes; Merck's 2nd Kelun ADC deal; Astellas' cell and gene therapy hub Featured Story | By Nick Paul Taylor AstraZeneca has axed a Moderna-partnered cardiovascular disease candidate from its phase 2 pipeline. Months after reporting positive trends on exploratory efficacy endpoints, the Big Pharma has pushed the mRNA candidate out the door while also dropping its Wee1 inhibitor after many years of development. read more |
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Top Stories By Annalee Armstrong Sarepta Therapeutics’ shares saw a nice boost early Friday morning as the biotech declared its intent to seek an early accelerated approval for the Roche-partnered Duchenne muscular dystrophy gene transfer therapy SRP-9001. read more By Max Bayer,Annalee Armstrong Pfizer is certain that its CD47 portfolio won't get gobbled up by the kind of clinical woes that have befallen its competitors. read more Sponsored by: PathAI Learn how Bristol Myers Squibb is unlocking new insights in translational research and development by transforming pathology with artificial intelligence. read more By Max Bayer Robert Califf threw his support behind the FDA's longstanding cancer czar, backing a proposal by Richard Pazdur for the agency to be more judicious in accepting single-arm trial data to nab accelerated approval. The prospect of limiting the trials has irked some in the biopharma industry. read more By Nick Paul Taylor Novo Nordisk has added more threads to the data tapestry it is weaving in support of the once-weekly insulin icodec, dropping positive top-line results from two phase 3a studies in its six-part Onwards program. read more By Conor Hale DeepMind's AI is helping researchers visualize the nearly 200 million proteins that form the basis of life for animals, plants, bacteria and more—spanning almost every organism on the planet that has had its genome sequenced. read more By Fraiser Kansteiner Biogen is angling to parry claims it misled investors on the assumed success of its Alzheimer’s disease med, Aduhelm. Wednesday, the Big Biotech filed a motion in Massachusetts federal court to dismiss a lawsuit brought by shareholders in February. The suit alleges that Biogen knew its drug was flawed but pushed for approval regardless. read more By Ben Adams Bausch + Lomb is tapping into the social media craze for TikTok in a unique marketing campaign for its eye drop Lumify. The campaign asks you not to dance with your feet but with your eyes and offers up a chance to win a makeover with Vincent Oquendo. read more By Teresa Carey This week on "The Top Line," we discuss how to move forward from Alzheimer's latest drug development setback and what the industry needs to do to make a real environmental difference. We also chat about how AI in drug R&D is growing up and ways to handle the cell and gene therapies' sticker shock. read more By Robert King New guidance from the Biden administration issued a stern reminder to health insurers they must offer birth control without any cost sharing under the ACA. read more By Max Bayer,Gabrielle Masson Former leader of Amgen’s early development work is headed to Affini-T as CMO. VTv Therapeutics finds new CEO after predecessor left within months after starting. Flare hopes permanent CEO hire can spark clinical success. read more By Angus Liu Takeda's oncology department took a triple whammy on both the commercial and R&D sides. Merck has signed a second antibody-drug conjugate deal with Kelun Biotech. Astellas is building a new campus in the Bay Area. And more. read more Resources Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Lumanity Join us, as we explore the commercial readiness challenges and practical realities of driving a successful launch in the cell and gene therapy space. Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. 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 Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. 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 Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 