Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA authorizes Moderna, J&J Covid-19 boosters, allows mix-and-match shots (Politico) (Reuters) (FDA)
- A C.D.C. panel is meeting for debate on boosters and the ‘mix-and-match’ strategy. (NYTimes)
- A 30-Year Campaign to Control Drug Prices Faces Yet Another Failure (NYTimes)
- Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large study (BioPharmaDive) (Reuters)
- Senators back FDA's plan to require mandatory prescriber education for opioids (Endpoints)
- FDA issues refuse-to-file letter for application for Barth syndrome (FDA)
- EU regulator verdict on Moderna COVID-19 booster shot next week (Reuters)
- EXCLUSIVE EU decision on Russia's Sputnik V shot 'impossible' this year – source (Reuters)
- Canada signs deal with Pfizer for millions of pediatric COVID-19 vaccine doses- Trudeau (Reuters)
- Kremlin says technological differences with EMA on Russia's Sputnik V certification (Reuters)
- WHO says studying Sweden pause of Moderna vaccine; Sputnik review resumed (Reuters)
- Sweden extends pause of Moderna vaccine for younger age group (Reuters)
- UK adds nerve disorder as rare side-effect of AstraZeneca COVID-19 vaccine (Reuters)
- WHO urges G20 to step up vaccine donations to the south (Reuters)
- Pulling back the curtain: U.K. to launch new system for registering clinical trials automatically (STAT)
- Russia reports cases of more contagious COVID-19 Delta subvariant (Reuters)
- Novartis extend COVID-19 vaccine deal with BioNTech (Pharmafile)
- Open Orphan to conduct first-ever COVID-19 human challenge trial (Pharmafile)
- Iran, turning more to imports, plans to abandon one of its homegrown Covid vaccines. (NYTimes)
- FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test (Fierce)
- Pharma Companies Must Assure Their ‘House Is In Order’ As FTC Takes Aim At Deceptive Endorsements (Pink Sheet)
- FDA selects Aetion Evidence Platform® to advance regulatory science and innovation (Press)
- NICE recommends gene silencing therapy for porphyria patients on NHS (PharmaTimes)
- How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance (Endpoints)
- Do Fast Track Regulatory Pathways Mean Quicker Reimbursement For Gene Therapies? (Pink Sheet)
- Ventyx nabs a $152M upsized IPO to challenge BMS' Zeposia—and a backer with intimate knowledge of its rival (Fierce)
- FDA approves Luminopia's VR-based digital therapeutic which treats lazy eye with TV time (Fierce)
- Pfizer throws its weight behind LNP player eyeing mRNA treatments for CF, PCD (Endpoints)
- As AI continues to entice Big Pharma, a Carlyle-led drugmaker syndicate shells out $430M for cloud computing player (Endpoints)
- Bristol Myers pledges to sell its Acceleron shares as activist investors circle Merck's $11.5B buyout — report (Endpoints)
- Epidarex, Sofinnova double down on a parallel take on 3rd-gen CAR-T — aiming straight at ovarian cancer (Endpoints)
- Hedge fund jumps in with Avoro activists in an attempt to derail Merck's $11B Acceleron buyout (Endpoints)
- Medtronic's newest insulin pump improves blood sugar control in children with diabetes: study (Fierce)
- Medtronic issues EU safety warning for Percept PC deep brain stimulation implant (Fierce)
- GSK taps at-home test maker Viome Life Sciences to research cancer, autoimmune diseases (mobihealthnews)
- Eli Lilly Must Pay Royalties In Diabetes Drug Row, Judge Says (Law360)
- J&J, Ethicon Beat Pa. Woman's Untimely Hernia Mesh Suit (Law360)
- Teva appeals to court to keep Hollywood parody videos under wraps in New York opioid case (Endpoints)
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