Recon: FDA greenlights first-ever vaccine targeting RSV; Eli Lilly plans to seek FDA approval for Alzheimer’s drug

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

In Focus: US

• First vaccine targeting RSV wins FDA approval. More are coming. (Washington Post) (Endpoints) (Fierce) (STAT)
• Lilly to seek FDA approval for Alzheimer’s drug that firm says slows decline (Washington Post) (Endpoints) (Fierce) (Fierce)
• For Lilly’s Donanemab, US FDA Commissioner Is Already Thinking About Post-Market Questions (Pink Sheet)
• FDA approves Avadel's narcolepsy drug after courts forced Jazz patent delisting (Endpoints)
• US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them (Pink Sheet)
• Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm (Fierce)
• Valneva, Pfizer delay their Lyme disease vaccine submission to 2026 (Endpoints)
• FDA cites quality issues at Rentschler and Eli Lilly facilities (Endpoints)
• CDC opens probe after 35 test positive for covid following CDC conference (Washington Post)
• PhRMA turns up the heat on PBMs with attack ad accusing them of limiting access to medicines (Fierce)
• Mirroring federal efforts, DeSantis signs new law on drug price transparency, PBM reforms (Endpoints)

• WHO experts to weigh whether world ready to end COVID emergency (Reuters) (Economic Times)
• International Off-Patent Industry's Wishlist For WHO Pandemic Accord (Pink Sheet)
• EU countries lay out framework for combating drug shortages (Fierce)
• EU Reforms Include ‘Prudent-Use’ Targets For Cuts To Antibiotic Consumption (Pink Sheet)
• Biogen finally scores win in its fight to prevent copycats of MS drug in the EU (Endpoints)
• NICE Pilots Show New Streamlined Approaches Accelerated Health Technology Assessments (Pink Sheet)
• Poland takes its COVID-19 vaccine fight to Pfizer’s shareholders, urging the company to be a good corporate citizen (Fierce)
• Swissmedic To Facilitate Exchanges With Companies Under Digital Transformation Drive (Pink Sheet)
• GSK staffers kick off series of strikes in UK for the first time in drugmaker’s history (Fierce)

• Moderna's surprise profit powered by deferred COVID orders (Reuters)
• Novo Nordisk: U.S. is priority for weight-loss drug over new markets (Reuters)
• Amid booming demand, Novo to hold back some doses of obesity drug Wegovy for new U.S. patients (STAT)
• Belldegrun-backed biotech real estate group nabs $130M to construct eight-story hub in Philly (Endpoints)
• Reverse mergers say hey as biotechs trade low, hunt for alternatives and launch few IPOs (Endpoints)
• Pfizer to begin Haleon exit in coming months — report (Endpoints)
• Merck KGaA, on an expansion spree, plots raw materials production plant in Korea (Fierce)
• Forge Biologics secures manufacturing and development deal with LabCorp (Endpoints)
• As Amgen’s revenues slide, so too do sales at its bug buyout target Horizon (Fierce)
• For Eli Lilly’s head scientist, Alzheimer’s results cap a 25-year scientific quest (STAT)
• CAR-T research is flourishing but is hampered by outdated precautions, experts say (STAT)
• Regeneron's Eylea drug sales hit by competition from 'new kid in town' (Reuters) (Fierce)
• Purdue Pharma Seeks Up to $6.7 Million in Executive Bonuses (Bloomberg)
• Boehringer Ingelheim breaks ground on €285M API plant in Germany (Fierce)
• Roche creates organoid research institute to shake up drug discovery and development (Fierce)

• Olympus Gets Greenlight From FDA For Its New Endoscopy System (MedTech Insight)
• TEAM-NB To Roll Out Evidence Of Compliance With Extended MDR Period Rules “Soon” (MedTech Insight)
• CMS Announces End To Free OTC COVID-19 Tests For Medicare Patients (MedTech Insight)
• At Musk’s brain-chip startup, animal-testing panel is rife with potential conflicts (Reuters)
• BD raises full-year forecasts again, expects Alaris infusion pump approval (MedTech Dive)

• Amgen sues Sandoz to block biosimilar of blockbuster bone drug (Endpoints)
• Trial set for drugmaker accused of profiting from government patents (Washington Post)
• Cancer Patient Suing Blue Cross Wins Proton Beam Therapy Appeal (Bloomberg)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
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