Today's Rundown Trial flops see Pfizer cut GlycoMimetics pact, Merck ax KalVista research deal Trump tries again to reduce NIH budget, spares FDA from cuts Ex-Pfizer oncology R&D lead lands at Fierce 15 winner Vividion Therapeutics Arbutus axes another hep B program due to safety worries LogicBio rocked by FDA clinical hold on genome editing trial Outset Medical secures another $125M for its portable dialysis machine FDA eases hold as Marker Therapeutics T-cell manufacturing issues addressed Featured Story | | | Tuesday, February 11, 2020 Two Big Pharmas have decided to walk away from two small biotech deals after disappointing trial results: Pfizer from GlycoMimetics and Merck from KalVista Pharmaceuticals. |
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Top Stories Tuesday, February 11, 2020 President Donald Trump has again proposed to reduce the budget of the National Institutes of Health (NIH). Trump, who has seen his previous attempts to cut NIH’s spending rebuffed by Congress, took a softer line on the FDA, which is set to get a small budget bump if the President’s plan is enacted. Tuesday, February 11, 2020 Pfizer’s longtime cancer research head Robert Abraham, Ph.D., has become the new chief scientific officer at a San Diego biotech. Tuesday, February 11, 2020 Arbutus Biopharma is officially canning its RNA-destabilizing hepatitis B program due to safety concerns found in preclinical studies carried out in two species. The move comes four months after the company delayed the treatment’s phase 1 study to look more deeply into its safety profile. Tuesday, February 11, 2020 The FDA has placed a clinical hold on LogicBio Therapeutics’ planned genome editing trial. LogicBio wants to trial the therapy in methylmalonic acidemia patients aged two years and up but has run into resistance at the FDA. Monday, February 10, 2020 Outset Medical has raised $125 million to accelerate the U.S. commercialization of its all-in-one hemodialysis machine. The former Fierce 15 winner previously raised $132 million for its U.S. expansion in August 2018. Tuesday, February 11, 2020 Marker Therapeutics says it has overcome an issue in its MultiTAA-specific T cell manufacturing process that led the FDA to stymie its trial in patients with acute myeloid leukemia (AML) who have had stem cell transplant. With new reagent suppliers on board, it says the FDA has now lifted the hold. | | [Survey] Bioavailability Toolkit Share insight on the drug developer’s perspective on bioavailability enhancement technologies and the reasoning behind the use of certain technologies in preclinical and early-stage clinical development. Take survey. |
Resources Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? Sponsored by: USDM Life Sciences Details on the FDA’s upcoming Computer System Validation guidance Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 