Weekender: FDA clears Pfizer's coronavirus vaccine for young kids, moving US to next stage of rollout

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BROUGHT TO YOU BY — Signant Health eCOA: When data quality matters Discover how digital capture of clinical data is more reliable than traditional, paper-based methods. Download Whitepaper.   FDA clears Pfizer's coronavirus vaccine for young kids, moving US to next stage of rollout The authorization makes the shot available to nearly 28 million kids between the ages of 5 and 11, though a CDC panel next week could hold significant sway over who among them should be vaccinated. Cortexyme drug fails in Alzheimer's trial, but company sees validation of unorthodox approach Cortexyme shares lost more than three-fourths of their value after the the biotech's therapy, which is designed to work differently than drugs like Aduhelm, missed both primary goals in a late-stage study. Roche's refillable eye implant becomes Eylea's latest threat The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug. Sponsored Content by MMIT Pathway or Perish: Overcoming barriers to access in oncology Oftentimes it's the lack of pathway placement that's restricting access to your drug, not the payer's coverage policy. Here's how to avoid making unnecessary rebate payments and ensure access for patients. With approval plans underway, Lilly's next move is to test its Alzheimer's drug against Biogen's Alongside a new earnings report, Lilly announced plans for a late-stage study to evaluate whether donanemab is better than Aduhelm at clearing amyloid beta plaques. Vertex aligns with another CRISPR gene editing startup A new alliance with Mammoth Biosciences marks the latest evidence of Vertex's interest in gene editing, which has already been the focus of multiple deals with emerging biotechs.  Takeda reels in a cell therapy research partner with 'build-to-buy' deal The Japanese drugmaker is acquiring GammaDelta Therapeutics, a partner since 2017, and its research on allogeneic cell therapy for cancer. Recommended For You Improve your recommendations: click here to update your profile. Deep Dive A play-by-play of the FDA's meeting on Pfizer's vaccine for kids Experts on the agency's panel dug into questions on the vaccine's safety in younger children, as well as uncertainty over how widely it should be used. Catch up on the discussion here.  Featured Resources FROM: Medrio Traditional, virtual or hybrid clinical trials. We're your partner in DCTs. How to source decentralized technologies that empower patients AND inform stakeholders Exploring the meteoric rise of hybrid clinical trials Decentralize your trials today From Our Library Webinar - on demand Life Science Companies: Accelerate Growth with Cloud ERP NetSuite Webinar - on demand How Pharma Can Ease the Pressure on Patient Support Programs IQVIA Trendline Vertical integration and consolidation in healthcare Webinar - on demand The B2B Buyer Has Changed. Your Marketing Should, Too Cvent Playbook Vaccinating the Globe: Choosing the Right CDMO Partner PCI View all resources Best of What We're Reading Science 2021’s Top Employers engage, nurture, and harness the power of scientists Politico ‘Bereft’: How Operation Warp Speed’s decisions left the world waiting for a vaccine Business Insider Regeneron's top scientist George Yancopoulos tells us the one big thing he thinks gene-editing biotechs are doing wrong Fierce Biotech Frazier has raised an $830M public life science fund. Here's how it plans to invest the cash Science The pandemic turned them into celebrities. Now scientists are grappling with new power—and internet hate BioCentury How Woodcock has changed FDA Suggest a story we should read Upcoming Events Important ADME & Drug-Drug Interaction Considerations for Successful Drug Development Nov. 11, 2021 - Nov. 11, 2021 | Webinar 2pm ET Future Perspectives for Biopharma Quality: A Focus on People, Process, and Proactive Risk Mitigation Nov. 16, 2021 - Nov. 16, 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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