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

• 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)

• 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)

• 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)

• 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)