FDA committee takes on complex gene therapy safety questions with Novartis' Zolgensma providing lessons learned Novartis scraps kidney transplant trial after control beats study drug Cassava CEO, ‘dazed and confused’, takes to biotech defense handbook by blaming short sellers for woes Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform through Collaboration and IRT Expertise Pfizer, jumping headfirst into the RSV vaccine race, kickstarts phase 3 test Rhythm, without missing a beat, installs Shapiro to replace departing CMO Forte searching for new direction after only therapy flunks midstage atopic dermatitis trial Abbott gets its blood pumping by acquiring clot-removing devicemaker Walk Vascular A mini-CRISPR system could be 'Swiss knife' in gene editing First Biogen, now the FDA: Congressional Democrats request agency records about Aduhelm's approval Researchers replicate COVID-19 infections with lab-grown ‘mini-lungs’ CDC: 'Perfect storm' fueled a spike in healthcare-associated infections in 2020 Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant Fierce Pharma Asia—Sourcing Moderna's COVID vaccine contaminant; Astellas' gene therapy pause; Takeda's cancer drug flop Chutes & Ladders—FDA's top two vaccine leaders to depart in the fall as questions loom over booster shots Featured Story | By Annalee Armstrong,Kyle LaHucik Gene therapy biotechs are ready with an arsenal of clinical trials to test the potentially groundbreaking treatments in humans. But an array of complicated safety concerns remain to be addressed—including the correct animal models to use in preclinical research to ensure human testing is safe and how to deliver the medicines safely. That’s the focus of a two-day marathon advisory committee meeting hosted by the FDA this week. read more |
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Top Stories By Nick Paul Taylor Novartis’ kidney transplant trial has crashed and burned. Having moved into phase 2 on the strength of evidence that iscalimab may prolong the durability of transplanted kidneys, Novartis has stopped the study after an interim analysis found it may be worse than standard of care. read more By Ben Adams The Cassava saga continues as its chief Remi Barbier has come out, guns blazing, against accusations that the biotech may have deliberately misdirected investors on its recent Alzheimer’s readout. 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 Ben Adams Pfizer is starting a key late-stage trial of its experimental vaccine against a nasty form of a cold virus that can cause pneumonia and death in the young and old, as the race to get a decent respiratory syncytial virus (RSV) vaccine on the market heats up. read more By Nick Paul Taylor A series of chief medical officers (CMOs) have hit the exits over the past month, with biotechs such as Black Diamond Therapeutics, Replimune and Avidity Biosciences all disclosing departures in recent weeks. Rhythm Pharmaceuticals joined the club on Thursday—but unlike others it had a successor in place and ready to take on the job. read more By Annalee Armstrong Forte Biosciences has decided that an atopic dermatitis treatment called FB-401 just isn’t its cup of tea after a phase 2 clinical trial failed to improve severity of the condition. read more By Andrea Park Looking to grow its footprint in endovascular surgery, Abbott has taken a step forward by announcing its intent to acquire Walk Vascular. read more By Kyle LaHucik Researchers at Stanford University say they have created a mini version of the CRISPR-Cas system that could be easier to deliver into cells for gene therapies. The mini gene-editing system comes after CRISPR pioneer Intellia revealed first-in-human gene editing data in June. read more By Noah Higgins-Dunn Months after high-ranking Democrats demanded Biogen answer for concerns shrouding its controversial Alzheimer’s drug Aduhelm, the pair of lawmakers are now making a similar request to the FDA itself, according to a letter sent to interim commissioner Janet Woodcock, M.D. read more By Conor Hale Researchers at UC San Diego have grown miniature human lungs in a lab dish that they say come the closest to mimicking the real thing. read more By Dave Muoio Between the heavy use of catheters and ventilators and industry-wide shortages of staff and supplies, the COVID-19 pandemic reversed years of progress in reducing preventable hospital infections, according to a new CDC analysis of national surveillance data. read more By Eric Sagonowsky Only a few days after Eli Lilly's COVID-19 antibody combo of bamlanivimab and etesevimab made its return in more than 20 states, federal officials are resuming distribution nationwide. In a Thursday alert, officials said Lilly's drug "can be used in all U.S. states, territories, and jurisdictions" based on data about variants circulating nationwide. read more By Angus Liu Moderna and partner have pinpointed the probable source of foreign particles that were found in its COVID-19 vaccine doses in Japan. Astellas paused a gene therapy trial after noting a liver safety signal. A Takeda blood cancer candidate failed in late-stage testing. And more. read more By Kyle LaHucik The FDA's top two vaccine leaders said they would depart the agency in late-October and November, and the timing of their announcement raises questions around COVID-19 vaccine booster concerns. Former Moderna Chief Medical Officer Tal Zaks, M.D., Ph.D., joined Teva's board. Galapagos founder and CEO Onno van de Stolpe will step down once a successor is found as the biotech has lost billions in value recently. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Cascade Chemistry by Aceto Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs. Sponsored by: ConnectiveRx Topple barriers to getting patients started on therapy. Guide them with mobile. 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. The MedTech Conference 2021 September 27 - 30, 2021 DPHARM: Disruptive Innovations in Clinical Trials September 28-29, 2021 | Boston, MA w/Virtual Option Let A Digital Sherpa Uncomplicate The Path for Patients ODIN – Data Transfer Made Easy Virtual U.S. Healthcare Compliance Certificate Program Announcing the 9th International mRNA Health Conference November 09-10, 2021 | Mercure MOA Berlin & Online 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 | 