AstraZeneca delivers rare win for treme in liver cancer, bouncing back from flops to beat Bayer's Nexavar Chinese biopharma powerhouse continues charge into siRNA with Silence R&D pact Industry vets launch Tentarix with $50M to develop antibody-based cancer-killing treatments Sponsored: Purify DNA, RNA, proteins, and cells for many applications Resilience commits $30M to launch new biotechs out of Harvard with focus on therapeutics, biomanufacturing Sponsored: Partnership to unlock the full potential of data to advance the science and practice of healthcare: Q&A with Syntropy and the University of California, Irvine Greenwood takes the top job at Kojin Therapeutics, leading an all-woman biotech C-suite A return to the top: Former FDA Commissioner Califf reportedly Biden's pick for Woodcock's role Inhalable anti-COVID-19 antibody from TFF and Augmenta tamps down viral load in hamsters FDA panel backs half-dose Moderna booster for the elderly and others at high risk Editor's Corner—Medicare Advantage open enrollment opens today. Hear top industry execs discuss the trends to watch Despite Merck's oral COVID-19 drug, antibodies by Regeneron, GSK and others still have billions in sales ahead: analyst Exscientia AI study spots which blood cancer therapies work and which don't Fierce Pharma Asia—Takeda's cell, gene therapy deals; BMS-BeiGene Abraxane brawl Chutes & Ladders—J&J science chief Stoffels the latest C-suite leader to retire Featured Story By Nick Paul Taylor Can AstraZeneca pick its CTLA-4 inhibitor up off the canvas? After seeing the drug knocked down by a series of setbacks, AstraZeneca has now reported improved survival in a phase 3 checkpoint inhibitor combination study in liver cancer patients. read more |
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| Top Stories By Nick Paul Taylor Hansoh Pharmaceutical is making a multifront push into siRNA. Days after disclosing a siRNA pact with OliX Pharmaceuticals, the Chinese biopharma powerhouse has unveiled a separate alliance with Silence Therapeutics. read more By Emmy Lucas Industry vets from Eli Lilly, Amgen, Regeneron and more are ready for their next venture: launching biotech Tentarix Biotherapeutics with a $50 million series A fundraising to advance the field of multifunctional biotherapeutics. read more Sponsored by: Thermo Fisher Scientific Discover ways your Thermo Scientific™ KingFisher™ system can empower your research beyond SARS-CoV-2. read more By Kyle LaHucik National Resilience is not running in circles these days. The manufacturing and tech shop appears to have its ducks in a row, and the latest high-profile move is a $30 million commitment to forming new companies with Harvard researchers. read more Sponsored by: Syntropy Q&A with Syntropy and UCI on their collaboration to work across their enterprise and with external partners to advance health research and patient care. read more By Ben Adams Kojin Therapeutics likes to do things differently: Its platform is looking to—for the first time—drug the ferroptosis-sensitive cell state and treat a host of diseases, and, now, an all-woman leadership team will help make that happen. read more By Kyle LaHucik Robert Califf led the FDA in the last year of former President Barack Obama's second term in the White House. Now, he's reportedly President Joe Biden's nominee to fill the spot Janet Woodcock has held on an interim basis for nine months. read more By Arlene Weintraub TFF Pharmaceuticals teamed up with Augmenta Bioworks to develop an inhalable COVID-19 antibody drug made using a “thin freezing film” technology licensed from the University of Texas at Austin. In hamster models, the drug reduced viral load one day after infection, they reported, and the companies hope to start clinical trials next year. read more By Kevin Dunleavy An FDA advisory committee recommended authorization of the Moderna COVID-19 vaccine as a booster for people 65 and older and others at high risk. The panel signed off on boosters at least six months after completion of the original two-shot Moderna series. read more By Paige Minemyer Later this month, you'll have the opportunity to hear more about the biggest Medicare Advantage trends, straight from the executives in the trenches. read more By Angus Liu The success of Merck & Co.'s oral antiviral against COVID-19 immediately triggered concerns over the market prospect of antibody therapies. But, as one analyst sees it, those antibody products by Regeneron, GlaxoSmithKline and other companies still have an important role to play that pills can’t make up for. read more By Conor Hale Using AI in personalized medicine could boost treatment success in patients with aggressive blood cancers, an Exscientia study found. The method follows a basic idea: Take a test to see whether a drug will work before it’s given. But AI allows clinicians to trial a whopping 139 different treatments in each patient—no risk required. read more By Angus Liu Takeda doubles down in cell and gene therapy with new deals with Immusoft and Poseida Therapeutics. Bristol Myers Squibb is pulling the plug on its Abraxane China licensing deal with BeiGene amid legal tension. And more. read more By Kyle LaHucik Johnson & Johnson Chief Scientific Officer Paul Stoffels, M.D., will retire at the end of the year, following the lead of CEO Alex Gorsky, who also departs soon. Emile Nuwaysir led Bayer's $1 billion bet on Parkinson's disease, and now he heads up gene therapy biotech Ensoma. Genentech's early cancer research leader Shiva Malek jumps to Novartis' NIBR oncology unit. read more Resources Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. 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Virtual U.S. Healthcare Compliance Certificate Program October 11 – 14, 2021 Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event Learn what it takes to get a drug developed and approved October 20-21, 2021 | Live & Online Fierce Health Payer Summit October 26, 2021 | Virtual Event Learn how to develop and get regulatory approval for medical devices November 3-4, 2021 | Live & Online Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online Fierce Biotech Forum 2022 | Virtual Event |