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Today's Rundown 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. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. 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: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. 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. Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: IBM Watson Health IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. 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. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. | 
