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Today's Rundown 2019’s top 15 clinical trial flops (and a flip-flop) 'Another swing, another miss' for Gilead as NASH combo flops in phase 2 Novartis dumps asthma program after another set of phase 3 flops After jumping the BMS-Celgene ship, Paul Biondi boards Flagship Pioneering Wave Life Sciences crashes as it tosses out DMD drug amid trial flop Deciphera files for approval of cancer drug ahead of schedule Horizon's eye drug teprotumumab wins FDA panel backing in unanimous vote How Novartis' cancer drug Tasigna restores critical dopamine that's lost to Parkinson's disease Charles River Labs snaps up HemaCare, eyeing the growing cell therapy market FDA approves Tandem's closed-loop artificial pancreas to automatically control insulin doses Featured Story | | | This year’s top 15 list has been drawn up to include trials whose failure we judge to have had material consequences on their sponsors and the patients for whom the drugs are being developed. The catalog includes multiple trials for aggressive brain cancer, Alzheimer’s disease, nonalcoholic steatohepatitis and heart disease. |
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Top Stories Monday, December 16, 2019 Gilead’s NASH pipeline took another hit as a pair of treatments failed to move the needle on liver scarring in a phase 2 study, both on their own and in combination. The Big Pharma is digesting the data with regulators to figure out what’s next for the programs. Monday, December 16, 2019 Novartis’ fevipiprant has failed another pair of phase 3 clinical trials, prompting the Swiss pharma to halt further development of the DP2 antagonist in asthma. The setback means Amgen, AstraZeneca and Novartis have now targeted DP2 without success, raising doubts about whether Gossamer Bio will fare better when it delivers data next year. Monday, December 16, 2019 Days after leaving Bristol-Myers Squibb (and amid its big merger deal with Celgene), its former dealmaker Paul Biondi has landed at major biotech VC Flagship Pioneering. Monday, December 16, 2019 Shares in Wave Life Sciences sunk 50% Monday morning on the news it is throwing out suvodirsen in Duchenne muscular dystrophy after it failed to move the needle in a key measurement. Monday, December 16, 2019 Deciphera Pharmaceuticals has filed for FDA approval of ripretinib in patients with advanced gastrointestinal stromal tumors. The filing moves Deciphera closer to establishing ripretinib as an option for patients failed by drugs from Bayer, Novartis and Pfizer. Friday, December 13, 2019 People with a rare eye disease may soon get an alternative to surgery. All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab, a drug Horizon Therapeutics picked up in its buyout of River Vision two years ago. The agency is expected to make a decision by March 8. Monday, December 16, 2019 Georgetown University researchers have been studying Novartis’ cancer drug Tasigna as a potential treatment for Parkinson’s disease since 2013. Now, they're out with new research from a phase 2 trial showing that the drug boosts dopamine levels in the brain while also reducing levels of neurotoxic proteins, halting the decline of both motor and non-motor functioning. Monday, December 16, 2019 Charles River Labs is stumping up $380 million in cash to buy out cell therapy biomaterials producer HemaCare. Monday, December 16, 2019 The FDA approved its first automatic insulin dosing system designed to deliver correction boluses as well as adjust background insulin levels, to help prevent bouts of high and low blood sugar in people with Type 1 diabetes. Resources Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. 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Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. 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