Recon: FDA delays decision on Beigene drug due to COVID restrictions; Pfizer seeks Japanese approval for COVID vaccine in young children

| 14 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novartis, BeiGene’s PD-1 drug the latest to hit FDA wall as pandemic stalls another review (Fierce) (Reuters)
  • FDA again spells out safety concerns with oral type 1 diabetes drug while denying Lexicon's attempt to overturn a CRL (Endpoints)
  • In post-Roe guidance, HHS tells 60,000 pharmacies: Don't stop dispensing abortion drugs (Endpoints) (Reuters)
  • Abortion Drug Bans Make Pharmacies Wary of Common Arthritis Pill (Bloomberg)
  • COVID Vaccines In Young Children: FDA, Sponsors Estimated Benefits Against Unclear Myocarditis Risk (The Pink Sheet)
  • Intercept’s NASH Hopes: A Case Study For Implications Of US Pricing Bill (The Pink Sheet)
  • NIH scientists move closer to vaccine holy grail: a universal flu shot (Fierce)
  • Tobacco-Free Vape Makers Face First FDA Enforcement Moves (Bloomberg)
In Focus: International
  • Pfizer, Biontech seek Japan regulatory approval of COVID shot for young children (Reuters)
  • EU adds severe allergies as side effect of Novavax COVID vaccine (Reuters)
  • No Let Up In Downward Pressure On EU Drug Prices (The Pink Sheet)
  • Ombudswoman says missing EU Pfizer vaccine deal texts are "wake-up call" (Reuters)
  • EU seeks to upgrade safety rules for blood, tissue, cell donations (Reuters)
  • WHO Panel Advises Against Generic Antidepressant to Treat Covid (Bloomberg)
  • Canada approves Moderna's COVID vaccine for children aged 6 months and older (Reuters)
  • COVID cases down in Americas but Omicron subvariants driving new infections (Reuters)
  • India reports first case of monkeypox (Reuters)
  • Bosnia reports first case of monkeypox infection (Reuters)
Pharma & Biotech
  • Novartis’ $650M cash bet on a near-term FDA OK for BeiGene’s China PD-1? It just got delayed indefinitely (Endpoints)
  • In $500M deal, Bayer offloads testosterone deficiency drug Nebido to Grunenthal (Fierce)
  • Novo Nordisk nabs priority review voucher for $110M from Marinus as the biotech preps first drug launch (Endpoints) (Fierce)
  • Sanofi CEO Paul Hudson offloads two portfolios to German pharma company in continued effort to prune products (Endpoints)
  • In pursuit of Bayer and Regeneron’s Eylea, Roche shows Vabysmo’s superior staying power (Fierce) (Biospace)
  • Reeling from PhII flop, CytomX lays off 40% as execs go back to drawing board, seek new deals (Endpoints)
  • Amid global expansion, Samsung Biologics pledges emissions drops in new ESG report (Endpoints)
  • Hemophilia Gene Therapies Should Have REMS For Approval, National Hemophilia Foundation Says (The Pink Sheet)
  • They blazed a trail by having their brains linked to computers. Now they want to help shape the field’s future (STAT)
  • Spanish AEMPS Latest To Gain Notified Body Designation Under EU Medical Device Regulation (MedTech Insight)
  • Eko secures heart murmur AI clearance for digital stethoscopes (Fierce)
  • Rising procedure volumes boost hopes for Abbott, J&J as orthopedics lag, survey finds (MedTech Dive)
  • Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases (MedTech Dive)
Government, Regulatory & Legal
  • Judge Approves Viatris Settlement of EpiPen Lawsuit for $264 Million (FDAnews)
  • Teva warns ‘skinny label’ ruling could sow ‘competition-killing uncertainty’ for generics  (Fierce) (STAT)
  • Alnylam sues Moderna and Pfizer again over Covid-19 vaccine patent infringement (Endpoints)
  • Teva and Allergan reach another opioid settlement, this time for $54M with San Francisco (Endpoints)
  • Synthego Wins Stay of Patent Suit on Agilent Genome-Editing Tech (Bloomberg)
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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you