Merck pauses 'very important' HIV program after seeing red flag in phase 2 trial of once-weekly combo BMS heart drug, center of its $13B MyoKardia buyout, hit by FDA delay Cassava ploughs on with 2nd phase 3 trial of Alzheimer's med despite federal investigation Sponsored: Tips on building a resilient cGMP chemical supply chain Enanta dumps oral hep B program after safety warnings in early test Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? J&J previews $60B-a-year future with plans to go after viruses that have long evaded vaccine makers Fresh from $2.5B pact, BridgeBio, Helsinn expand collaboration to cover preclinical cancer prospects Biogen's Aduhelm 'likely' linked to Alzheimer's patient's death, RBC analyst says Labcorp adds to drug development, device testing services with Toxikon buy Personalized T cells could offer an immunotherapy option to children with brain tumors Healthcare associations, experts urge employers to swiftly adopt OSHA's 'commonsense' vaccination requirements Fierce Pharma Asia—Biocon, Viatris' insulin biosim launch; AstraZeneca China's deceleration; Huahai's FDA warning lift Chutes & Ladders—Califf nominated to lead FDA again after Woodcock's lengthy interim stint Featured Story | By Nick Paul Taylor A “very important” part of Merck’s HIV strategy has come off the rails. Just months after talking up the importance of MK-8507, Merck has paused development of the asset in response to midphase data that also raised questions about the backbone of all the company’s planned HIV regimens. read more |
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Top Stories By Annalee Armstrong Just days ago, Bristol Myers was touting new data for the targeted heart drug mavacamten. Now, the Big Pharma has announced that the FDA has extended the decision date for the drug, which was nabbed through the $13 billion buyout of MyoKardia. read more By Kyle LaHucik Cassava Sciences is forging ahead with a second phase 3 trial of its troubled Alzheimer's drug just three days after revealing a federal investigation into the company. read more Sponsored by: Thermo Fisher Scientific Plan for growth and meeting patient demand with cGMP supply chain expert tips on sourcing, mitigating risks, and partner selection from Thermo Fisher Scientific Production Chemicals and Services. read more By Ben Adams Enanta Pharmaceuticals is shutting down work on its oral hepatitis B program for EDP-721 after serious safety red flags were raised in a phase 1 study. read more Sponsored by: Q2 Solutions Clinical lab testing at home - fact or fiction? Many operational and patient-related considerations must be taken when using a decentralized approach to specimen collection at or near the trial participant's home. read more By Annalee Armstrong Johnson & Johnson has a lofty goal to become a $60 billion-a-year drugmaker by 2025. To reach that goal, the healthcare giant is going to take a crack at a couple of viruses that have long eluded vaccine makers. read more By Nick Paul Taylor BridgeBio Pharma and Helsinn are tightening their ties. Having teamed up to develop one drug in March, the partners have decided to work together on more prospects, starting with a potentially first-in-class cancer candidate. read more By Fraiser Kansteiner In the aftermath of an Alzheimer's patient's death, Biogen and industry watchers have been trying to piece together the situation and determine whether the company's recently minted Alzheimer's drug should carry any blame. The answer? Probably so, one analyst says. read more By Andrea Park Situating the Massachusetts-based CRO under the Labcorp umbrella will give the testing giant a stronger foothold specifically in the Boston area, a hotbed for biotech and pharma development. read more By Arlene Weintraub Scientists at Children’s National Hospital identified peptides that are unique to medulloblastoma tumors and then engineered T cells so they could recognize and target those proteins. They believe the therapy could offer a personalized immuno-oncology option for children diagnosed with this common tumor type. read more By Dave Muoio The American Medical Association, the American College of Physicians and dozens of other healthcare organizations and individual health experts called on employers to voluntarily implement OSHA's "reasonable and essential" vaccination requirements. read more By Angus Liu Viatris launches two versions of its Biocon-partnered Lantus biosimilar. Growth of AstraZeneca's star China unit dropped. The FDA has lifted a warning lettering on the Chinese drug manufacturer behind a global valsartan recall three years ago. And more. read more By Kyle LaHucik Robert Califf is President Joe Biden's nomination to lead the FDA, a post he held for the last year of Barack Obama's administration, after Janet Woodcock helmed the agency on a lengthy interim basis. Biogen's R&D chief Al Sandrock is retiring as the company reels from multiple hurdles to its Aduhelm rollout. And Pfizer's CFO becomes the latest executive at the Big Pharma to retire. read more Resources Sponsored by: Thermo Scientific Production Chemicals and Services Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study 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: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. 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. Sponsored by: Blue Matter Consulting Paper describing how the chronic insomnia market offers big lessons for any biopharma company thinking about getting into digital therapeutics in any therapeutic area. Sponsored by: TransPerfect Life Sciences Every detail is important when selecting a new eCOA solution; learn more about the current eCOA landscape, best practices, and crucial considerations for successful eCOA solution deployment in this white paper. Sponsored by: Informa Pharma Intelligence and Oracle Health Sciences New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic. 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: 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 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 Fierce New Product Planning Summit December 1-2, 2021 | Boston, MA 2nd Annual Symposium on Translational Medicine and Biomanufacturing December 2—3, 2021 Fierce Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA
January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Pharma Drug Safety Summit February 8-9, 2022 | Location TBD Fierce Business Development and Licensing Summit March 2022 | San Francisco, CA Fierce Medical Affairs Strategic Summit (MASS) East April 2022 | New Jersey Fierce Health IT Summit April 20, 2022 | Virtual Event Fierce Trial Master File Summit May 2022 | Location TBD Fierce Promotional Review Committee Compliance and Best Practices Summit April 2022 | New Jersey Fierce Digital Pharma Innovation Week June 2022 | Virtual Event Fierce Biotech Next-Gen June 29, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce Biotech Forum October 2022 | Location TBD Fierce Biotech Virtual Forum October 19, 2022 | Virtual Event | 