Today's Rundown Roche dumps antisense hep B drug after bagging rival asset Eli Lilly cuts three cancer drugs amid Q4 clear-out Sanofi's rare disease drug hits endpoint, teeing up 2021 filing Spring Bank scraps hep B program after patient death, 'unexpected' side effects Ex-Shire/Takeda clinical trials chief Ivarsson lands at Moderna More than half of clinical trials still hidden from public view: report MIT researchers develop beating 'biorobotic hybrid' for testing heart valves GSK, Pfizer and more sign on for Accenture, Google's new data platform Featured Story | | | Thursday, January 30, 2020 Roche has dropped an antisense hepatitis B drug shortly after licensing a rival therapy from Dicerna Pharmaceuticals. RG6004 fell off Roche’s pipeline as part of a periodic cull that affected a handful of other experimental programs. |
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Top Stories Thursday, January 30, 2020 It’s that time of year when Big Pharmas are reporting revenues and zeroing in on the pipeline updates they want you to know about, but as so often is the case, is being very quiet about any negative news. Thursday, January 30, 2020 Sanofi’s olipudase alfa has improved outcomes in patients with a rare genetic disease. The primary endpoint success in a phase 2/3 trial, coupled with midphase pediatric results, sets Sanofi up to file for approval in acid sphingomyelinase deficiency next year. Wednesday, January 29, 2020 Spring Bank Pharmaceuticals is pulling the plug on its lead program, an antisense drug for hepatitis B, due to safety concerns, including one patient death. The company is on the hunt for a partner to license the program and will pivot its own efforts toward its STING portfolio for the treatment of cancer and inflammatory diseases. Thursday, January 30, 2020 Another ex-Shire executive is jumping the Takeda ship. Melanie Ivarsson, Ph.D., who led clinical programs at Shire before overseeing global clinical operations at Takeda, is now chief development officer at Moderna. She joins as the mRNA biotech advances and expands its pipeline. Thursday, January 30, 2020 A new report out of the U.K. has spotlighted the continuing opacity of clinical trial reporting, with nearly 60% of more than 4,200 studies not showing results within a year, as mandated by new rules in the U.S. Wednesday, January 29, 2020 Researchers at MIT have developed a bionic hybrid heart designed not for patients, but for engineers—to better test out new designs of prosthetic heart valve implants and replacements. Thursday, January 30, 2020 Google Cloud President Tariq Shaukat heard "an overriding sentiment" when he spoke with pharma and life science executives recently at the J.P. Morgan Healthcare Conference: The pharma industry is behind in using digital technology. To that end, his company is partnering with Accenture on an open architecture platform to accelerate discovery, research and delivery. | | [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 | 