Weekender: FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization

Signup | Forward Weekender Feb.​ 27,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — CoverMyMeds 2021 Medication Access Report With new survey data and patient insights, the 2021 Medication Access Report explores patients' access barriers and the technology that can help. View the report.   FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization In a unanimous vote, the panel of experts gave a green light to the FDA for clearing J&J's shot, judging the benefits of vaccination outweigh its risk. A play-by-play of the FDA meeting on J&J's one-shot coronavirus vaccine Members of an advisory committee unanimously supported use of the vaccine, but were wary of challenges that could lie ahead for J&J, such as what to do if a two-dose regimen proves superior. Why this week's FDA meeting on J&J's coronavirus vaccine will be important The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues. Sponsored Content by SGS Analytical quality by design: Development of cell-based bioassays Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate and robust. Former AveXis executives launch gene therapy startup with uncommon targets Sean Nolan and Joe Nolan, former leaders at the Zolgensma developer, are behind Jaguar Gene Therapy, which plans to research treatments for a rare metabolic disease as well as genetically linked autism and diabetes. Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda. AstraZeneca withdraws immunotherapy in bladder cancer after trial failure The British drugmaker's decision to pull Imfinzi from what was its first approved treatment setting hints at the limitations of immuno-oncology drugs. FDA review supports safety, efficacy of J&J coronavirus vaccine In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.   BROUGHT TO YOU BY — Camargo Beginning with the Rare Disease Patient in Mind How do you expand perspectives to drug development strategy and trial design for a population that is unlike any other? Discover six ways to reverse engineer your development strategy to accommodate the true rare disease patient journey. Read the white paper.   From Our Library Webinar - on demand The Role of Analytics in Strategic Decision-Making for Pharma and Biotech Doctor Evidence Playbook Accelerating Time to Market Through Clinical Supply and Manufacturing Optimization N-SIDE View all resources Best of What We're Reading The New York Times Germans Clamor for Covid Vaccines, but Shun AstraZeneca’s Offering Reuters Roivant to buy Silicon Therapeutics for $450 million to boost drug discovery FierceBiotech FDA tells Merck to show more data for its OncoImmune COVID-19 drug as EUA pushed back BioCentury Democratic opposition could sink Woodcock’s chances to be nominated as permanent FDA commissioner STAT GSK's Covid-19 drug falls short in trial, but may benefit older patients Boston Business Journal Cellarity, Flagship startup that aims to treat 'any disease,' raises $123M Suggest a story we should read 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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