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Gilead taps brakes on $4.9B bet after rival's failure, pushing blood cancer data out to 2022 AbbVie’s Vraylar turns in mixed results in depression, but pharma decides to file for approval anyway Daiichi jettisons ADC after flunking early solid tumor test Sponsored: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy Signet Therapeutics gets a $10M top-up for next-gen cancer bets SPACtacular spooky season for Arbor Rapha's blank check; a $180M Entrada onto Wall Street FDA adds new restrictions, warning labels for breast implants following reports of cancer Alexion children's book series aims to help parents talk to kids about life with a rare disease HHS proposes nixing controversial Trump-era 'sunset' rule due to massive resources needed for compliance Merck's big earnings in Q3 play second fiddle to enthusiasm for COVID pill's potential Fierce Pharma Asia—Takeda's GammaDelta buy, FDA warning letter removal; Fujifilm's massive North Carolina plant Chutes & Ladders—Alnylam founding CEO Maraganore to hand baton to COO, President Greenstreet Featured Story | By Nick Paul Taylor Gilead’s $4.9 billion bet on Forty Seven has run into a delay. Weeks after Takeda’s rival drug flunked a pivotal trial, Gilead has pushed back the release of data from a phase 1b study designed to support accelerated approval. read more |
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Top Stories By Angus Liu AbbVie’s antipsychotic Vraylar could get a major boost from a potential expansion into depression. But like some other late-stage contenders, the drug’s clinical results fell short of a home run. read more By Nick Paul Taylor Daiichi Sankyo’s antibody-drug conjugate team has hit a rare bump in the road, dumping a gastrointestinal stromal tumor candidate after seeing “no clear responses” in a phase 1 trial. read more Sponsored by: Wacker Biotech Plasmid DNA Manufacturing: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy. Learn more about our plug & play platform. read more By Ben Adams Little U.S.-China startup Signet Therapeutics has bagged a second seed round worth around $10 million as plots a path to the clinic. read more By Kyle LaHucik Another preclinical biotech is hitting the public markets, with rare diseases company Entrada Therapeutics landing on the Nasdaq to generate $181.5 million in proceeds Friday. Entrada's entrance isn't the only IPO Friday: SPAC Arbor Rapha Capital is raising $150 million to buy a biopharma. read more By Conor Hale The agency curbed the sale and distribution of both saline- and silicone gel-filled breast implants, including products from Allergan, Johnson & Johnson’s Mentor division, Sientra and Ideal Implant. read more By Natalie Missakian Rachel Pegram, who has the rare disease generalized myasthenia gravis, wanted an easier way to explain her condition to her three-year-old daughter. So she worked with AstraZeneca's Alexion unit to create "Klara's Talent," the first in a children's book series to help families discuss rare diseases with their kids. read more By Robert King The Department of Health and Human Services proposed getting rid of a controversial Trump-era rule that would spark a massive agency review of all existing regulations, arguing that the previous administration vastly underestimated the cost of compliance. read more By Kevin Dunleavy On Thursday, when Merck reported third-quarter earnings that significantly exceeded expectations, the good news was almost an afterthought as the tantalizing future of COVID-19 oral treatment molnupiravir was the dominant topic of an investors call. read more By Angus Liu Takeda is buying out U.K. T-cell therapy developer GammaDelta Therapeutics. The Japanese pharma has resolved an FDA warning letter regarding its Hikari plant while working on several pipeline hiccups. Fujifilm has started construction of a $2 billion biologics plant in North Carolina. And more. read more By Kyle LaHucik Alnylam Pharmaceuticals' founding CEO John Maraganore will hand the baton to President and Chief Operating Officer Yvonne Greenstreet by year-end and remain in a consulting role until the end of March. Medivir named its fourth CEO in two years, snagging a 25-year AstraZeneca veteran. Aadi Bioscience named Gilead's Immunomedics chief medical officer as CMO as it awaits FDA approval of its first drug. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. 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: 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: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. 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. Fierce Health Payer Summit October 26, 2021 | Virtual Event 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 New Product Planning Summit December 1-2, 2021 | Boston, MA Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week January 11, 2022 | San Francisco, CA & January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Biotech Forum 2022 | Virtual Event Fierce Pharma Drug Safety Summit February 2022 | Location TBD | 