Recon: European industry group voice opposition to pharma overhaul; FDA approves Sarepta’s DMD gene therapy for some children

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Lupin wins approval for first US generic of Boehringer Ingelheim’s COPD blockbuster Spiriva (Fierce) (Endpoints)
• FDA Rejects Aldeyra’s Eye Cancer Injection, Citing Lack of Well-Controlled Studies (BioSpace) (Fierce)
• US FDA approves Sarepta's gene therapy for rare muscular dystrophy in some kids (Reuters)
• Pfizer, GSK RSV shots get tepid recommendation from CDC advisory panel (Fierce) (Reuters)
• Pfizer, GSK US RSV Vaccine Uptake Likely Hurt By ACIP’s Weaker Recommendation (Pink Sheet)
• Pfizer’s Talzenna snags broader prostate cancer nod than AstraZeneca and Merck’s rival PARP med (Fierce)
• As Adderall shortages persist, Takeda’s rival Vyvanse is now in short supply (Fierce)
• A looming penicillin shortage threatens pregnant adults with syphilis and their newborns (STAT)
• Brookings offers ideas on how to improve shortages of sterile injectables (Endpoints)
• ChatGPT Poses New Regulatory Questions for FDA, Medical Industry (Bloomberg)
• US FDA Issues Warning Letter to Glenmark Pharma’s Monroe Factory (Bloomberg)
• ‘The sleeping giant is waking up’: FTC raises the pressure on pharma dealmaking (Endpoints)
• PhRMA joins legal battle over Inflation Reduction Act’s ‘price-setting’ measures (Fierce) (Endpoints)
• Harsh New Fentanyl Laws Ignite Debate Over How to Combat Overdose Crisis (NYT)
• House GOP inquiry over gain-of-function research targets a scientific giant (STAT)
• Xylazine, or ‘tranq,’ is making opioid overdoses harder to reverse (STAT)
• Doctors’ lobby doubles down on the fight against expanding open access to research (STAT)

• European companies outline opposition to proposed overhaul of pharma policy (STAT) (Reuters)
• Novo Nordisk says EMA raised safety signal on drugs including semaglutide (Reuters)
• EU Fast Track Review Sought For Avacincaptad Pegol, mRNA-1345 & Troriluzole (Pink Sheet)
• Risk of mosquito-borne diseases rising in Europe, health agency says (Reuters)
• Proposed Methodologies For EU Joint Clinical Assessment Are Threat To ATMPs and Rare Disease Patients (Pink Sheet)
• Exclusive: Gambia tightens rules for Indian drugs after cough syrup deaths (Reuters)
• Over 40 Questions From Health Canada On How To Prevent Drug Shortages (Pink Sheet)
• New DNA test aims to make cervical cancer screening more accessible in low-income countries (STAT)

• Moderna 'laser-focused' on AI, from clinical development to marketing (Endpoints)
• Novartis-Backed Tagworks Raises $65M Series A to Further ADC, Click-to-Release Tech (BioSpace)
• Tourmaline Bio reverse merges into Talaris and raises funds to target thyroid eye disease and pharma rivals (Endpoints)
• Merck consolidates New Jersey operations at ‘reimagined ‘ headquarters in Rahway (Fierce)
• Federation Bio cuts undisclosed number of staff months after launching first trial (Fierce)
• Amid the AI gold rush, a new company forms to vet models and root out weaknesses (STAT)
• Physicians rate Janssen, Merck and Novo Nordisk best for customer experience in US — survey (Endpoints)

• Germany Moves Ahead Of EU With National Patient Data Use Draft Law (MedTech Insight)
• After FDA rebuke, Owlet relaunches baby-monitoring ‘sock’ with agency’s blessing (Fierce) (MedTech Dive)
• Surmodics soars on FDA approval of drug-coated balloon, triggering $27M Abbott milestone payment (Fierce)
• Surgical Device Maker Surgalign Files For Bankruptcy, Sells Assets At Auction (MedTech Insight)
• BD sells off surgical instruments unit to Steris for $540M (Fierce) (MedTech Insight)
• Exact Sciences pads the case for next-gen Cologuard test with improved study results (Fierce)

• Supreme Court Gives Government Leeway To Dismiss False Claims Act Suits (Pink Sheet)
• U.S. seeks a new trial over royalties on Gilead HIV prevention pills (STAT) (Bloomberg)
• Bankrupt Endo to Ditch Auction to Sell to Lenders for $6 Billion (Bloomberg)