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

ReconRecon | 28 February 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory and Legal
  • 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)
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.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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