Roche-backed AC Immune finds even mixed-bag Alzheimer's data are enough to make shares explode The descent of van de Stolpe: Galapagos CEO exits after R&D setbacks wipe out billions in value GSK, Korean biotech SK go head-to-head against AstraZeneca's COVID-19 shot with their experimental vaccine Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform through Collaboration and IRT Expertise J&J's HIV vaccine fails phase 2b, extending long wait for an effective jab Versanis Bio snags $70M for a ditched Novartis muscle drug, with a little help from its old CEO Joe Jimenez A year after a death and accompanying trial hold, Poseida hopes for reprieve with early solid tumor CAR-T data Key vaccine leaders departing FDA as COVID-19 booster questions linger Mayo Clinic, nference AI studies find antibody treatment may reduce hospitalization in high-risk COVID cases Louisiana hospitals mend damaged roofs, coordinate patient transfers following Hurricane Ida Featured Story | By Annalee Armstrong Semorinemab has shown the first clinical evidence of a tau-targeting monoclonal antibody in patients with mild-to-moderate Alzheimer’s disease in a phase 2 study, Roche’s Genentech and AC Immune said Tuesday. The therapy reduced the rate of cognitive decline, meeting one of the co-primary endpoints of the study. read more |
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Top Stories By Nick Paul Taylor Exits are hard to time. Onno van de Stolpe rode high for years after founding Galapagos. Yet, after presiding over a period in which Galapagos’ share price fell 80%, wiping out billions of dollars in value, van de Stolpe is hitting the exit on a low ebb—and leaving with the future of the biotech in doubt. read more By Ben Adams GlaxoSmithKline has been a little late to the COVID vaccine game and stumbled with partner Sanofi on the way, but it’s now hoping to rival and maybe even beat out AstraZeneca’s vaccine as it starts a new test with a new partner. read more Sponsored by: Almac Group When your goal is to identify effective and ineffective treatments more quickly than traditional trials through a Complex Innovative Design, the right IRT system is crucial. read more By Nick Paul Taylor The wait for an HIV vaccine goes on. Johnson & Johnson, having seen peers including Merck swing at HIV and miss, has reported the failure of a vaccine based on similar technology to its COVID-19 jab to protect women from infection with the virus. read more By Kyle LaHucik Versanis Bio emerged with a $70 million series A to test a former failed Novartis drug in a phase 2 study for obesity. Backing the biotech is former Novartis CEO Joe Jimenez, who was in the top spot when bimagrumab flunked a phase 2b/3 study in a rare, muscle-wasting disease. read more By Ben Adams The death of a patient in its solid tumor trial last August hit Poseida hard, but since then it has seen the hold lifted and is now reporting some early and broadly positive data from that same therapy. read more By Annalee Armstrong Two key vaccine leaders will leave the FDA this fall, just as the agency faces key decisions over COVID-19 booster shots and as variants take a bite out of the shots’ efficacy. The FDA’s Officer of Vaccines Research and Review Director Marion Gruber, Ph.D. and Deputy Director Phillip Krause, M.D. will depart the agency. read more By Andrea Park After kicking off the new year by expanding their year-old data analytics-based research collaboration, Mayo Clinic and nference’s union continues to bear fruit. read more By Dave Muoio Despite no injuries from the storm within their facilities, executives from Louisiana's largest health system say they and other providers have their hands full with repairs, transfers, workforce accommodations and the looming threat of post-storm admissions. read more Resources Sponsored by: ConnectiveRx Topple barriers to getting patients started on therapy. Guide them with mobile. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. DPHARM: Disruptive Innovations in Clinical Trials September 28-29, 2021 | Boston, MA w/Virtual Option The MedTech Conference 2021 September 27 - 30, 2021 Let A Digital Sherpa Uncomplicate The Path for Patients ODIN – Data Transfer Made Easy Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 | 