Sangamo's Fabry gene therapy clears early clinical test, firing starting gun on preparations for phase 3 Bayer poaches Otsuka's chief medical officer Koenen to head up its clinical operations Amgen plays multi-specific matchmaker in quest to tackle the undruggable Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success VC shop Mission BioCapital raises $275M 5th fund with focus on incubating startups Sponsored: Intranasals in Clinic Now Positioned for $71 Billion Nasal Delivery Market After flops, Ironwood starts pipeline rebuild with liver disease deal Pfizer adds to Parthenon's $65M war chest to back battle at the tumor barrier Aptose inks $408M biobucks deal with Hanmi for access to myeloid inhibitor Allara launches at-home hormone test for diagnosing polycystic ovary syndrome Turning CAR-T tech against solid tumors by targeting protein fragments in cancer cells ASH: Chasing AbbVie and J&J's Imbruvica, BeiGene's Brukinsa fleshes out competitive leukemia data again CMS: Healthcare workers must receive their first COVID vaccine by Dec. 5 to continue Medicare, Medicaid participation Featured Story By Nick Paul Taylor Sangamo Therapeutics has posted clinical data on a therapy it hopes will shake up the Fabry disease market. The gene therapy showed encouraging safety and efficacy signs in the small study, prompting Sangamo to start preparations for a phase 3 clinical trial. read more |
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| Top Stories By Ben Adams As Bayer looks to ramp up its R&D work in the gene therapy space amid a host of biotech tie-ups, the German pharma is tapping Christoph Koenen as its new global head of clinical development and operations in its R&D unit. read more By Annalee Armstrong Amgen already broke into the “undruggable” market with the approval of Lumakras, but that was just the tip of the iceberg for a pipeline strategy aimed at pursuing targets that were previously considered out-of-reach. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Kyle LaHucik Mission BioCapital pooled together $275 million for its fifth fund, which has already gone toward seven companies and is dedicated to incubating new biotechs and other life sciences startups. The Cambridge and Silicon Valley VC shop also hired 24-year Pfizer veteran Michael Taylor and former Forma Therapeutics CEO Steve Tregay. read more Sponsored By: Avance Clinical the Australian CRO for global biotechs Australia’s Avance Clinical: how intranasal biotechs can expedite trials with rapid approval processes - including no IND and a 43.5% incentive rebate - to tap $71 billion market read more By Nick Paul Taylor Ironwood Pharmaceuticals has advanced plans to build out its pipeline, securing a chance to license Cour Pharmaceuticals’ liver disease candidate CNP-104 after getting a look at early-phase data. read more By Emmy Lucas Pfizer Ventures is one of many investors ponying up $65 million for a new biotech developing anti-cancer therapies to forge an attack on the protective barrier that shields tumors from the immune system. read more By Kyle LaHucik Aptose Biosciences likes what it sees in a phase 1/2 myeloid kinome inhibitor from Hanmi Pharmaceutical and is paying up to $420 million for the exclusive worldwide rights for the drug. The San Diego biotech snags rights to the South Korean Pharma's inhibitor across all indications. read more By Conor Hale After launching a virtual care platform aimed at PCOS this past summer, Allara is now debuting a diagnostic tool to sift through multiple hormone biomarkers. It hopes to reduce the diagnosis time from an average of three years to as many days. read more By Angus Liu A University of Pennsylvania team has developed a new type of engineered immune cell called “peptide-centric” CAR-T that's designed to shrink solid tumors by targeting proteins inside cancer cells. CAR-T cells developed with the technology eradicated neuroblastoma in mouse models and could move into human trials in 2022 or 2023. read more By Angus Liu After clinical wins in smaller indications, BeiGene has once again posted competitive data for its Brukinsa—this time in the all-important newly diagnosed leukemia—that could further pressure AbbVie and Johnson & Johnson's market leader Imbruvica. read more By Dave Muoio To continue participating in Medicare and Medicaid, healthcare facilities must have policies in place to ensure all eligible employees receive an initial COVID-19 shot by Dec. 5 and their second by Jan. 4. CMS said that it expects the requirement to reach more than 17 million healthcare workers across the country. read more | LabConnect is the leader in innovative central laboratory services for advanced therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. | Resources 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: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest 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: 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: 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: 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: 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. Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Fierce Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 VIRTUAL November 17-18, 2021 Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Fierce New Product Planning Summit December 1-2, 2021 | Boston, MA 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 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 Biotech Forum 2022 | Virtual Event Fierce Pharma Drug Safety Summit February 8-9, 2022 | Location TBD May 2022 | Location TBD |