Today's Rundown Featured Story | | | Thursday, February 13, 2020 Ipsen has recorded a €669 million ($728 million) partial impairment on a rare disease drug it bought last year. The prospects of the drug, palovarotene, took back-to-back hits around the end of 2019, leading Ipsen to dramatically dial down its expectations. |
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Top Stories Thursday, February 13, 2020 Revolution Medicines outraised its $100 million IPO goal, banking $238 million to advance a suite of cancer programs targeting RAS, a family of proteins that’s been notoriously hard to drug. Amgen reported the first clinical data from a KRAS inhibitor at last year’s American Society for Clinical Oncology meeting. Thursday, February 13, 2020 Deciphera Pharmaceuticals has been handed a priority review from the FDA for its cancer drug ripretinib. Thursday, February 13, 2020 The FDA has accepted Bristol-Myers Squibb’s lisocabtagene maraleucel for priority review, setting the stage for a mid-August decision on whether to approve the CAR-T therapy. Bristol-Myers arrives at the FDA with data to suggest the cell therapy can hold its own against Gilead’s Yescarta and Novartis’ Kymriah. Thursday, February 13, 2020 No diabetes drug can tackle the underlying cause of the disease. Scientists at the Icahn School of Medicine at Mount Sinai hope to change that. They found adding an existing medicine to popular GLP-1 receptor agonists can regenerate insulin-producing beta cells at high rates in both lab dishes and mice. Thursday, February 13, 2020 In recent years, China has become a key region for clinical trial research sites, but the ongoing quarantine and partial travel lockdown to and from the country is putting a strain on research. Thursday, February 13, 2020 Medtronic is looking to augment not only its work in robotic surgery but efforts across all of its procedural offerings through the acquisition of Digital Surgery, London-based maker of data analytics, artificial intelligence and training programs for the operating room. Thursday, February 13, 2020 Acorda suffered a major blow in late 2018 when it lost four patents on multiple sclerosis med Ampyra and forfeited millions of dollars to generic competitors. The drugmaker slashed jobs and costs, then shifted to its $800 million Parkinson's hopeful Inbrija. But that hasn't worked out, either. |  | [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. | 
