Today's Rundown Featured Story | | | Monday, February 10, 2020 Anti-amyloid beta antibodies in development at Eli Lilly and Roche have failed to improve outcomes in a phase 2/3 Alzheimer’s disease trial. Despite the setback, Roche is continuing two phase 3 trials of its asset in a broader population of Alzheimer’s patients. |
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Top Stories Monday, February 10, 2020 Biohaven’s glutamate-targeting drug fell short in a phase 3 study in generalized anxiety disorder, failing to beat placebo at reducing patients’ anxiety scores. The data “do not support continued development” of the drug for GAD, but the company will keep pushing it forward in other areas, including Alzheimer’s disease, said CEO Vlad Conric, M.D. Monday, February 10, 2020 In a quiet Securities and Exchange Commission filing (with no press release), Wave Life Sciences announced it's to cut its staff by nearly a quarter after a crushing few months. Monday, February 10, 2020 Britain-based biotech Enterprise Therapeutics has hired Novartis Venture Fund managing director David Morris, M.D., as its next chief medical officer. Monday, February 10, 2020 A £550 million ($711 million) deal to find new homes for Neil Woodford’s biotech holdings has collapsed, raising the prospect that stakes in companies including Immunocore will be auctioned off for knock-down prices. Monday, February 10, 2020 Long-troubled Valeritas, manufacturers of a wearable, disposable insulin pump, has filed for Chapter 11 bankruptcy as part of a plan to hand off its business to the specialty drugmaker Zealand Pharma, through a court-supervised sale. Monday, February 10, 2020 Hoping to improve the durability of CAR-T treatments in multiple myeloma, University of Utah researchers created a CAR-T that targets both cancer cells and cancer stem cells using an antibody against the surface molecule CD229. It produced promising results in mouse models of the disease, as well as samples taken from multiple myeloma patients. |  | [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: 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. | 
