Weekender: FDA, CDC support resuming use of J&J vaccine after advisory panel vote

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BROUGHT TO YOU BY — Lonza Your partner for Cell & Gene Therapies Commercial Manufacturing Learn about Lonza Houston, one of four global CGT centers of excellence. Learn more →   FDA, CDC support resuming use of J&J vaccine after advisory panel vote While health officials have documented more cases of a rare blood clotting syndrome associated with J&J's vaccine, a CDC committee supported use of the shot with an added warning.  A look ahead at the FDA meeting that could decide the future of 6 cancer drug approvals Accelerated approvals for immunotherapies from Merck, Bristol Myers Squibb and Roche might soon be withdrawn. Here's a detailed look at why. Bluebird to withdraw gene therapy from Germany after dispute over price The biotech will cut staff, primarily in Europe, after negotiations with German health authorities resulted in a price lower than Bluebird had sought.  Sponsored Content by IQVIA Real World Data: Leverage transformative data sources to accelerate study timelines, shorten time to market and more Real World Data provides increasingly significant value throughout all stages of a product's lifecycle. The time to embrace it is now. Here's why. Lilly to seek first approval of an autoimmune drug for hair loss Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review.  Positive data in hand, TG Therapeutics readies MS drug for FDA review If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies. A startup raises $336M to make a better antibody drug for COVID-19 Adagio Therapeutics, a well-financed spinout of antibody developer Adimab, could challenge Regeneron and Eli Lilly if its drug candidate proves protective in clinical tests. Featured Resources FROM: Catalent Optimize Oral Small Molecule Manufacturing [Webinar] Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules [Article] Roller Compaction: New Trends, Challenges, and Solutions [Exec Summary] A Roadmap for Early Development to Commercial Manufacturing From Our Library Trendline What you need to know about oncology's research boom View all resources Best of What We're Reading The New York Times With Few New Clotting Cases, Johnson & Johnson Pause Could Be Lifted Soon Life Sci VC Five Macro Risks To Biotech Coming Out of Washington | LifeSciVC The Financial Times Scientists split over advice on giving AstraZeneca jab to UK under-40s The Wall Street Journal Biotech Stocks Fall Out of Favor After Disappointing Trial Results, Big Rally Endpoints News As fears mount over J&J and AstraZeneca, Novavax enters a shaky spotlight Bloomberg Pfizer to Place 100 Young Minorities in New Fellowship Program Suggest a story we should read Upcoming Event Gene Therapy at a Crossroads: The Challenges and Opportunities Ahead May 11, 2021 - May 11, 2021 | Webinar 2pm ET Dive Into a Topic Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy Share BioPharma Dive: Daily Dive with others and get rewarded. You've referred 0 readers. To become an official Dive Insider, just successfully refer 10 contacts to BioPharma Dive: Daily Dive. Here's your link to share: https://www.biopharmadive.com/signup/insiders/?signup_referred_by=5f93078d7aa51972095c9316

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