Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

ReconRecon | 20 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • COVID vaccine rollout for US children close after CDC panel vote (Reuters)
  • Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing (STAT)
  • Comparing the Pfizer and Moderna Covid vaccines for young children (STAT)
  • Merck Explores Purchase of Biotech Seagen (WSJ)
  • FDA advisors mostly agree that Acadia’s Nuplazid isn't effective at treating Alzheimer’s-related psychosis (Endpoints)
In Focus: International
  • Pfizer to buy 8.1 percent stake in French vaccines company Valneva (Reuters)
  • EU drugs watchdog begins review of Moderna's variant COVID vaccine (Reuters)
  • WHO panel backs use of Omicron-adapted vaccine as booster dose (Reuters)
  • Greece Files Graft Lawsuit Against Novartis: Minister (Barron’s)
  • FTC could sanction AstraZeneca over alleged collusion (The Korea Herald)
  • China Tweaks On-Site Inspection Priorities As Registration Filings Soar (Endpoints)
  • BioNTech chief calls for speedy ruling on Covid vaccines that target latest strains (FT)
  • Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic (EMA)
  • EMA Management Board: highlights of June 2022 meeting (EMA)
Pharma & Biotech
  • Never forget that early vaccines came from testing on enslaved people (STAT)
  • WTO's IP waiver for vaccines is out and the response is generally negative — from all sides (Endpoints)
  • J&J inks clinical trial deal with Stand Up To Cancer, latest pharma to join cancer nonprofit study efforts (Endpoints)
  • Pushing for top spot in Big Pharma, AbbVie lands a key approval for its blockbuster Skyrizi (Endpoints)
  • More drug, fewer jabs: Novartis' Sandoz eyes EMA nod for high-concentration Humira copy (Fierce)
  • Teetering on the brink, Clovis abandons an early approval for Rubraca (Endpoints)
  • EU Proposes Changes To Labeling Of Investigational Drugs Under Clinical Trial Regulation (Pink Sheet)
  • Morcellation Containment System Guidance Stresses Leak Detection, Prevention (MedtechInsight)
  • The Pace Of Cyberattacks Is Accelerating. Can Regulators Keep Up? (MedtechInsight)
  • MDR And IVDR – Similar Step Ups, Varying Commercial Impacts (MedtechInsight)
Government, Regulatory & Legal
  • Bristol Myers petitions the Supreme Court in a final bid to prove Gilead's Kite infringed on CAR-T patents (Endpoints)
  • Generic Co. Asks Fed. Circ. To Undo Loss In Takeda IP Fight (Law360)
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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