Recon: FDA panel reviews Pfizer, GSK RSV vaccines; Merck scraps Keytruda prostate cancer trial after disappointing Phase III results

• Pfizer, GSK face FDA panel review in race for RSV vaccines (Reuters)
• FDA Grants Orphan Drug Designation to Jaguar Health for Crofelember for Microvillus Inclusion Disease (MVID), a Second Rare Disease Indication in the US (BioSpace)
• FDA Seeks to Further Restrict Unlawful Importation of Xylazine (Bloomberg) (WSJ)
• Pandemic-era insider trading scheme netted ex-Phlow exec and his cousin $1.5 M (Fierce)
• FDA is petitioned to boost enforcement of trial sponsors that fail to register studies or report results (STAT)
• Can Courts And States Override FDA's Drug Regulatory Authority? (Pink Sheet)
• Big-sellers from Merck, Novo and Lilly likely to face Medicare price negotiations: report (Fierce)
• New head of FDA’s neuroscience office takes over at crucial time (STAT)
• FDA needs to build in more flexibility for rare disease clinical trials (STAT)
• Medicare Use Of Gross Rx Prices In Negotiation Picks Would Limit Savings, Erode Rebates – Payers (Pink Sheet)

• Eisai, Biogen say Alzheimer’s drug Lecanemab getting priority review in China (Reuters)
• Removing Confidential Data In Clinical Trial Reports Is ‘Like Stepping On Lego’ (Pink Sheet)
• UK-EU Northern Ireland Deal Reinstates ‘Single UK Market For Medicines’ (Pink Sheet)
• After FDA snub, Akebia’s oral anemia drug Vafseo nears EU nod (Fierce)
• Two people died of cholera in northwest Syria post-quake civil defence (Reuters)

• Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer (Fierce) (Reuters) (Endpoints)
• Thervance takes another blow but vows to fight on with slimmed head count, new trial (Fierce) (Endpoints)
• AstraZeneca Rare Disease R&D Expansion Adds 500 Jobs At New Hub (BioSpace) (Endpoints)
• Bayer grapples with Eylea sales slowdown, sees trend continuing in 2023 (Fierce) (Reuters)
• Aptinyx, reeling from series of setbacks, dumps dementia drug, stops PTSD trial after phase 2 fop (Fierce) (BioSpace)
• Grifols’ shares tank 10% as 2023 outlook disappoints (Reuters)
• Fierce Biotech Layoff Tracker 2023: Theravance trims staff by 17%; Apexigen halves team (Fierce)
• UK biotech hands off mid-stage C. difficile drug in up to $570M deal (Endpoints)
• Decades after breakthrough, scientists still puzzling over mRNA delivery (Endpoints)

• EU Regulatory Round-Up, February 2023: EU Closes In On Adopting MDR Proposal (MedTech Insight)
• Manufacturers Can Now Apply For Clinical Advice Under EU Expert Panel Pilot (MedTech Insight)
• Abbott heart valve deteriorates faster than rival device, FDA says in notice (MedTech Dive) (Fierce)
• Getinge life support systems temporarily lose CE marks due to issues with sterile packaging (Fierce)
• European cardiologists recommend renal denervation as an adjunctive blood pressure treatment (MedTech Dive)

• Intercept Accords with Apotex, MSN Labs Nix Ocaliva Patent Trial (Bloomberg)
• Mylan, Pfizer, Others Ordered to Face Dermatology Antitrust Case (Bloomberg)
• Catalent Investors Call Shot Maker’s Mid-Pandemic Growth a Sham (Bloomberg)
• Attorney Fees of $2.83 Million Upheld in Array BioPharma Suit (Bloomberg)