Featured Story | By Annalee Armstrong For patients, there’s never been a better time for medical innovation. But how many biotechs is too many? read more |
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Top Stories By Nick Paul Taylor Astellas’ $550 million bet on menopause drug fezolinetant has hit unexpected turbulence. After acing a pair of phase 3 clinical trials and racing to regulators, Astellas has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia. read more By Kyle LaHucik AbbVie and Scripps Research will work together to make new antiviral treatments for COVID-19 to fill what the Big Pharma says are gaps in patient needs as the pandemic heads toward the endemic phase. read more By Nick Paul Taylor Nothing is going to grow from AnaptysBio’s ACORN. One year after flunking a palmoplantar pustulosis trial, the anti-IL-36R antibody imsidolimab has come up short in a phase 2 acne study. read more By Max Bayer Passage Bio is doubling down on a partnership with James Wilson, M.D., Ph.D, and his University of Pennsylvania lab even as the gene therapy biotech plans to trim its workforce 13% in the latest of a string of setbacks. read more By Kyle LaHucik Shoreline Biosciences, backed by Gilead and BeiGene, has poached the chief scientific officer of Pfizer's cancer vaccines and immunotherapies unit, Robert Hollingsworth, Ph.D. read more By Max Bayer Moderna has started dosing in a phase 1 trial for the second of two HIV vaccines it's developing, showing that it's all gas, no breaks for the mRNA-focused biotech as it races Excision BioTherapeutics for a breakthrough HIV therapy. The start of dosing comes roughly six weeks after it launched human trials for its first vaccine. read more By Kyle LaHucik CAMP4 Therapeutics hired former Translate Bio Chief Medical Officer Ann Barbier, M.D., Ph.D., for the same post and also added ex-Biogen R&D leader Al Sandrock, M.D., Ph.D., to its scientific advisory board. The new CMO will help the biotech get its first molecule, for Dravet syndrome, into the clinic. read more By Fraiser Kansteiner Top executives at pandemic juggernauts Pfizer and Moderna are at odds on the need for a fourth COVID-19 vaccine dose. One says a second booster is needed “right now,” while the other thinks a fourth mRNA shot may only be essential for older adults and the immunocompromised. read more By Andrea Park The Class I recall covers LuSys Laboratories’ antigen test kits for both saliva and nasal samples, as well as the blood-based antibody test. read more By Nick Paul Taylor Progenity is advancing its oral biologic drug delivery project using the successful completion of its study in healthy volunteers as a launchpad for a clinical trial in patients with ulcerative colitis. read more By Paige Minemyer AUSTIN, Texas—While health and medicine have made great, innovative strides in developing new therapies and models of care, there's still plenty of work to be done to ensure those innovations work for women, experts say. read more By Kyle LaHucik Researchers found two new small-molecule inhibitors that help fight off acute myeloid leukemia cells by targeting a protein key to the survival of leukemia tumor "seeds." Meanwhile, a different team of researchers found "one of the most essential genes" required for AML cell survival, potentially paving the way for another treatment option. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. 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: 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 Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Pharma PR & Communications Summit West June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Medical Affairs Strategic Summit (MASS West) September 2022 | San Diego, CA Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event 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 JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 
