Today's Rundown Akcea, Pfizer hit midphase goal, but data raise doubts about chances in NAFLD, diabetes Racing Blueprint, Lilly drug gets priority review for RET hopeful Rare disease biotech Passage Bio nabs Deerfield veteran as CEO Laurence Reid returns to biotech as he takes up Decibel CEO role After NASH flops, Conatus becomes Histogen via reverse merger Philips to drop its home appliances unit in healthcare pursuit, plus a new head of connected care Featured Story | | | Wednesday, January 29, 2020 A phase 2 trial of Akcea Therapeutics’ antisense treatment for cardiovascular and metabolic disease has hit its primary endpoint. The Pfizer-partnered antisense oligonucleotide cut triglyceride levels in people with hypertriglyceridemia, Type 2 diabetes and non-alcoholic fatty liver disease but failed to reduce liver fat or hemoglobin A1C. |
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Top Stories Wednesday, January 29, 2020 The FDA has granted a priority review to Eli Lilly’s selpercatinib, setting the stage for a third-quarter decision on whether to approve the RET inhibitor. Lilly based its filing on a phase 1/2 trial that linked selpercatinib to objective response rates of over 50% in heavily pretreated cancer patients. Wednesday, January 29, 2020 Passage Bio is losing its interim chief executive and co-founder Stephen Squinto, Ph.D., as it brings in a venture capitalist veteran to the helm. Wednesday, January 29, 2020 After leaving Warp Drive Bio two years back amid its takeover by Revolution Medicines, Laurence Reid, Ph.D., is back in a biotech driving seat. Wednesday, January 29, 2020 After its Novartis-partnered NASH drug failed a third midphase trial, Conatus Pharma was in trouble. It unveiled a plan to lay off 40% of its staffers and find “strategic alternatives” to stay afloat. Now, the company has found its lifeline—a reverse merger with regenerative medicine player Histogen. Tuesday, January 28, 2020 Philips is cementing its commitment to becoming a healthcare technology provider, with plans to split off or sell its consumer appliances division. It also announced that its connected care businesses—including enterprise patient monitoring services and digital records—would see new management. | | [Webinar] Accelerating Approval for Cell and Gene Therapies Thursday, February 27 | 12pm ET / 9am PT Developers of cell and gene therapies can run into complex clinical and regulatory hurdles when bringing treatments to patients. Join experts from Cardinal Health Regulatory Sciences to explore critical factors that can help reduce the risk of failure and increase speed to market. |
Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources 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: Benchling As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster? 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: ICON Clinical Research Ltd The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more. Sponsored by: snapIoT, Inc. Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials. Sponsored by: EVERSANA How are your launch strategies can convert “innovation” into value for patients? 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: 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: 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. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 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. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 