As Merck and Pfizer predict incoming billions from their COVID drugs, Roche culls pandemic ties with Atea Valo whacks SPAC merger, blaming 'market conditions' for end of $750M Khosla deal Eloxx ends long wait for phase 2 cystic fibrosis data. Market shrugs Sponsored: Tips on building a resilient cGMP chemical supply chain Gene on, gene off: Chroma Medicine turns lights on with $125M to control gene expression with ex-Editas, Regeneron leaders Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? Provention Bio hires 3rd exec in as many weeks as it awaits FDA meeting for rejected drug FDA grants de novo clearance to ALung's 'respiratory dialysis' machine AMA moves against doctors who are spreading COVID-19 disinformation Moderna, amid mounting pressure to address vaccine inequality, says it's working on new COVAX deal Ncardia inks $60M funding deal to expand discovery and commercial production services for stem cells Featured Story By Ben Adams Swiss major Roche is cutting its losses and casting aside its COVID drug collab with biotech Atea Pharmaceuticals. read more |
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| Top Stories By Nick Paul Taylor Valo Health’s merger with a Khosla Ventures SPAC has gone belly up. The partners terminated the deal, which would have left Valo with $750 million before expenses, “based on current market conditions, particularly in the biotechnology area.” read more By Nick Paul Taylor The long wait for phase 2 data on Eloxx Pharmaceuticals’ cystic fibrosis prospect is over—and yet the picture remains unclear. Eloxx brushed over the failure to improve lung function in the small, short clinical trial, choosing instead to focus on a narrow win against a biomarker endpoint. 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 Kyle LaHucik Chroma Medicine emerges with $125 million to bankroll development of epigenetic editing to create therapeutics that control gene expression. The biotech is led by former Editas Medicine and Regeneron leaders who will lead Chroma's efforts at silencing and activating genes across a range of therapeutic areas. 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 Kyle LaHucik Provention Bio has made three leadership hires since Nov. 5 as it awaits a Type A meeting with the FDA later this month to discuss its rejected lead drug, teplizumab, for the treatment of Type 1 diabetes. The biotech hired Jan Hillson, M.D., as SVP of clinical development after she served in the same role at Alpine Immune Sciences. read more By Conor Hale The FDA has cleared a new type of life-support device from ALung Technologies that helps remove carbon dioxide from the bloodstream before returning it to the body, similar to a dialysis machine. read more By Heather Landi The American Medical Association adopted a new policy Monday aimed at combatting COVID-related disinformation created by physicians and other clinicians. read more By Kevin Dunleavy An international coalition of more than 80 public health and humanitarian organizations has joined the appeal to Moderna to provide more global access to its COVID-19 vaccine. Amid the pressure, Moderna says it is working behind the scenes with Gavi/COVAX on a plan to deliver millions of shots to countries in need. read more By Kyle LaHucik Ncardia secured $60 million in funding from cell and gene therapy investment firm Kiniciti to boost its discovery, clinical and commercial production services of human-induced pluripotent stem cells. The proceeds will help Ncardia build more human cellular models to determine if drugs are safe and effective earlier in the development stage. 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. Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Drug Development Boot Camp® 2021 VIRTUAL November 17-18, 2021 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 Pharma Drug Safety Summit February 8-9, 2022 | Location TBD Fierce Business Development and Licensing Summit March 15, 2022 | San Francisco, CA Fierce Medical Affairs Strategic Summit (MASS) East April 2022 | New Jersey 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 Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce Biotech Forum October 2022 | Location TBD |