Regulatory Focus™ > News Articles > 2021 > 10 > Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter f

Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

Posted 21 October 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech                                                                                                                      
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe