Recon: Pfizer and GSK RSV vaccines get thumbs-up by FDA panel; FDA rebuffs Elon Musk’s bid to test brain chips in humans

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

In Focus: US

• Two for two: GSK follows Pfizer, secures adcomm thumbs-up for RSV vaccine in older adults (Endpoints) (Bloomberg) (Fierce) (Pink Sheet)
• Pfizer gets FDA panel’s backing in RSV vaccine race (Reuters)
• U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks (Reuters) (Forbes)
• Factbox: Neuralink, other brain-chip makers face long road to FDA approval (Reuters)
• Intellia Receives FDA Nod to Start Testing Crispr Therapy (Bloomberg) (BioSpace)
• FDA finally approves Reata's rare genetic disease drug (Endpoints)
• U.S. FDA panel to review expanded use of Merck-AstraZeneca’s cancer drug (Reuters)
• FDA schedules advisory committee hearing for Lynparza prostate cancer application (Endpoints)
• FDA rejects Cytokinetics' heart failure drug, but the biotech has a backup (Endpoints)
• 'You are not the drug sponsor': FDA declines petition to anoint Cassava's drug as 'breakthrough' (Endpoints)
• CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies (Endpoints)
• Lilly’s Insulin Cost Cutting Plan: Replacing Rebates With Cost Sharing Help At Point Of Sale (Pink Sheet) (Endpoints)
• Social Media: Use Of Influencers In Drug Promotion Requires Guardrails, Experts Say (Pink Sheet)

• EU Proposes To Chop EMA Committees, Drop Five-Year Renewals (Pink Sheet)
• Switzerland Sets Out New Rules For QR Codes Linking To Pharma Company Websites (Pink Sheet)
• European chemicals firms downbeat on 2023 prospects (Reuters)
• US CDC concludes cough syrups likely to blame for children’s deaths in Gambia – report (Reuters)
• ABPI Proposes ‘World-First’ Investment Facility As Part Of New Pricing Deal (Pink Sheet)
• More than half of the world will be overweight or obese by 2035 – report (Reuters) (STAT)

• Akorn Pharmaceuticals files for bankruptcy, closes facilities and will liquidate (Endpoints)
• Novo Nordisk touts expansion in Boston, cuts about 100 jobs in two other US cities (Endpoints) (Fierce)
• Sarepta won't need FDA adcomm, boosting Duchenne gene therapy's odds (Endpoints)
• Novavax raises warning about ability to stay in business (Endpoints)
• Merck KGaA expects 2023 profit to slip as COVID demand wanes (Reuters)
• Inovio’s endpoint switcheroo backfires as phase 3 misses on new measure, hits on old (Fierce)
• G1 sheds staff while Sorrento WARNs of cuts amid torrential downpour of industry layoffs (Fierce)
• A duo of deals sees Avenue secure rare disease med while Allist lands cancer drug (Fierce)
• Lilly Bets $630M on Pain Target Novartis Failed (BioSpace) (Endpoints)
• Vertex pays ImmunoGen $15M to use antibody-drug conjugates to improve CRISPR therapy (Fierce)

• Hillebrenner says FDA no longer waiting on Congress for LDT regulation (BioWorld)
• MedTech Europe IVDR Impact Report: The Good, The Bad And The Ugly (MedTech Insight)
• TEAM-NB Paper Offers Guidance For Manufacturers On IVDR Technical Files (MedTech Insight)
• US FDA Warns Of Safety Concerns For Bed Rails And Infant Incubators (MedTech Insight)
• FDA expands clearance of Theranica’s neuromodulation armband for migraine (Fierce)
• Bigfoot Biomedical expands footprint of connected diabetes system with FDA nod for Android app (Fierce)
• Boston Scientific to lay off 120 people at ex-Preventice site, continuing run of medtech cuts (MedTech Dive) (Fierce)

• Genentech sues Biogen for royalties on blockbuster MS drug (Reuters)
• This dental device was sold to fix patients’ jaws. Lawsuits claim it wrecked their teeth (Fierce)
• Bristol-Myers Beats Claim It Stalled Cancer Drug to Avoid Payout (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.
 
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