Recon: FDA panel narrowly backs Sarepta’s DMD gene therapy; Supreme Court declines to hear Teva’s ‘skinny’ label case against GSK

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

In Focus: US

• FDA advisors narrowly vote in favor of Sarepta’s DMD gene therapy (Fierce) (STAT) (Reuters)
• FDA Approves New Drug to Treat Hot Flashes (NYT) (BioSpace)
• Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says (Pink Sheet)
• Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets (Pink Sheet)
• Pfizer, Seagen kick off antitrust review of $43B merger. Will FTC get on board? (Fierce)
• Worries About Innovation Incentives Keep Some Generic, Patent Bills Out of HELP Legislation (Pink Sheet)
• FDA Action Alert: Krystal, Genmab/AbbVie, Pfizer and Intercept (BioSpace)
• Lawmakers call on FDA to create more uniformity in rare disease drug reviews (Endpoints)
• Biden taps cancer surgeon Monica Bertagnolli to head NIH (Reuters) (Endpoints)
• He defied Alzheimer’s for two decades. Scientists want to know how. (Washington Post) (STAT) (NYT)

• Progress on reducing infant and maternal deaths has stalled, WHO warns (Washington Post)
• EU report recommends healthcare investments based on experiences from Covid-19 (MedWatch)
• Increased Cancer Risk & Effectiveness Concerns Prompt EU-Wide Review Of Preterm Birth Medicine (Pink Sheet)
• With NICE nod, Gilead clears another regulatory hurdle in Europe for Hepcludex (Fierce)
• EU Parliament picks chief negotiator for upcoming pharma revision (MedWatch)
• Legal Challenge Could Put UK Drug Pricing Deal At Risk (Pink Sheet)

• Athenex files for bankruptcy to pave way for firesale of programs, ending 20-year run (Endpoints) (Reuters)
• AstraZeneca Expands ADC Portfolio with $600M Deal with LaNova (BioSpace)
• Novartis names Sandoz board members ahead of spin-off (Reuters)
• Lilly-Backed Nido Biosciences Launches with $109M to Target Neurological Diseases (BioSpace) (Fierce)
• In preliminary readout, GSK notches win for meningococcal vaccine (Endpoints)
• Parkinson’s drug candidate to prove its worth in phase I – and lure big pharma to the table (MedWatch)
• Gritstone, MEI join biotechs using earnings season to reshuffle pipeline priorities (Fierce)
• Identifying ‘gems’ before others do: J&J exec gives insider’s look at dealmaking spree (Fierce)
• Ozempic and Wegovy have taken over obesity treatment. Can they help with cancer too? (Fierce)

• EU Guidance On “Significant Change” Meaning For Legacy Products Is Updated (MedTech Insight)
• EU Health Budget Review Presents Historic Opportunity To Fix Medtech Funding, Says COCIR (MedTech Insight)
• Women, Don’t Wait: Task Force Advises Starting Mammograms At 40 (MedTech Insight)
• Industry Leaders Urge Congress, CMS To Expand Coverage Of Breakthrough Devices (MedTech Insight)
• Omeg Medical bags FDA approval for epidural guidance device (Fierce)
• Phillips reaches $62M SEC settlement over alleged violations of anti-bribery law in China (Fierce)
• Masimo’s CEO on battling Apple for the health wearable market (STAT)

• SCOTUS declines to take up 'skinny' label generic drug case, raising questions about future carve outs (Endpoints) (Reuters) (Fierce)
• Big Pharma, US Research Pacts in Flux After Gilead’s Trial Win (Bloomberg)
• AbbVie sues drug cost savings company over alleged fraudulent use of patient assistance program (Endpoints)
• Redacted Ruling Details Xspray Failure to End Bristol-Myers Suit (Bloomberg)