Today's Rundown BARDA loses leader in middle of race to create COVID-19 vaccine Roche culls key phase 3 drug trials, including a cancer med and an autism 'breakthrough' therapy Pfizer and new partner BioNTech nab approval to start closely watched COVID-19 vax trial Biogen aims for Q3 aducanumab filing, quashing expectations of a 2020 nod Gilead, Kite pen natural killer pact with little-known Australian cell therapy player Myovant's endometriosis med hits the mark in phase 3, setting up AbbVie face-off Shawver takes the wheel at I-O biotech Silverback Therapeutics Swiss researchers develop methods to sniff out coronavirus in the air Early treatment with Novartis' Mayzent stalls secondary progressive MS: study Featured Story | | | Wednesday, April 22, 2020 The U.S. agency leading efforts to develop a vaccine against COVID-19 has lost its leader. Rick Bright, a vaccine specialist, is moving to a new role in the National Institutes of Health (NIH) at a time when his former employer is scrambling to help biopharma make a COVID-19 prophylactic available. |
|
|---|
|
Top Stories Wednesday, April 22, 2020 As the first tranche of quarterly results starts coming through for Big Pharma, questions are naturally arising about the new threats from COVID-19, but Swiss major Roche is also sticking to the old playbook, quietly dumping trials of pipeline drugs. Wednesday, April 22, 2020 Pfizer has been granted approval in partner BioNTech’s native country Germany to kick-start a phase 2 test of their experimental mRNA vaccine for COVID-19. Wednesday, April 22, 2020 Since Biogen brought aducanumab back from the dead, it’s kept tight-lipped on its plans for the once-failed Alzheimer’s hopeful, letting analysts speculate in January that a filing would come “within weeks.” Now, four months—and no filing—later, the company is spilling the beans. It will complete the application in the third quarter. Wednesday, April 22, 2020 All the attention is currently laser-focused on Gilead’s COVID-19 hopeful remdesivir, but the company itself is still penning deals outside of infectious disease. Wednesday, April 22, 2020 Myovant Sciences is on a roll. Yesterday, it submitted its lead drug to the FDA as a monotherapy for prostate cancer. Today, it is unveiling positive phase 3 data for a combination built around the drug to treat endometriosis, a difficult-to-spot condition that can cause pelvic pain and infertility in women. Wednesday, April 22, 2020 After Sanofi snapped up Synthorx for $2.5 billion in January, the latter’s CEO, Laura Shawver, Ph.D., was out of a job. She wasted no time scoping out her next gig, eventually reuniting with an old colleague and landing at the helm of Silverback Therapeutics, a biotech working on a new kind of antibody-drug conjugate. Tuesday, April 21, 2020 In recent months, people across many different fields have tried to take what they know and pivot it toward the challenges posed by the COVID-19 outbreak: some that you may expect—such as diagnostics, healthcare and tech companies, of course—and some you may not. Tuesday, April 21, 2020 Novartis is looking to grow its new multiple sclerosis drug Mayzent in a crowded field, and, with Gilenya generics threatening, the newer MS medicine may need to carry even more weight. Tuesday, it racked up some new data that could help. Resources Sponsored by: Blue Latitude Health Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns. Sponsored by: BBK Worldwide Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic. Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Clinical Ink This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations. Sponsored by: Research Solutions Turn your drug failures into competitive advantage. Sponsored by: ICON How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations. Sponsored by: Copyright Clearance Center Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have? Sponsored by: Applied BioMath Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs 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: Outer Edge Technology To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help. Sponsored by: Patheon, by Thermo Fisher Scientific Poorly soluble molecules hindering your workflow? Sponsored by: eClinical Solutions Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. 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: Clarify Health Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ Drug Development Immersion April 23-24, 2020 | Boston, MA PEGS Boston – The Essential Protein Engineering & Cell Therapy Summit May 4-8, 2020 | Boston, MA 8-week Online Courses in Life Sciences Law and Compliance Virtual Course | May 31st, 2020 European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO 2020 Now Fully Virtual: Announcing BIO Digital June 8-11, 2020 | Virtual Event 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. | 