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March 21, 2022
by Joanne S. Eglovitch

Recon: FDA approves new Bristol Myers cancer immunotherapy; VRBPAC to discuss boosters, strain selection at 6 April meeting

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

In Focus: US
  • FDA advisers to discuss COVID vaccine boosters in April (Reuters)
  • FDA approves new Bristol Myers cancer immunotherapy (Reuters) (Fierce)
  • Bristol Myers lands $1.1B biobucks oncology pact with Volastra, a biotech with phones ‘ringing off the hook’ (Fierce) (Endpoints)
  • Marinus Pharmaceuticals Gets FDA Approval for Ztalmy (Bloomberg)
  • Bristol-Myers Sues AstraZeneca for Profits Lost to Imfinzi Sales (Bloomberg)
  • WH Reviewing FDA’s Long-Awaited Rx-To-OTC Proposed Rule (Inside Health Policy)
  • Warren Bid to Grab Xtandi Cancer Drug Patents Gets Firm Rebuke (Bloomberg)
  • Vaccines remained highly effective at preventing serious illness and death during omicron surge, CDC report says (Washington Post)
  • Boosters Become Big Pharma Free-for-All With More Shots Coming (Bloomberg)
In Focus: International
  • New EMA Chair Pledges Agility, Responsiveness & Solidarity In Turbulent Times (The Pink Sheet)
  • Pharma Companies Are Suspending Trials In Russia - But For Practical More Than Ethical Reasons (Scrip)
  • Lonza signs manufacturing agreement with Oasmia for ovarian cancer drug (Reuters)
  • EMA Assessing 'Slightly' Raised Heart Attack Risk With Two COVID-19 Vaccines (The Pink Sheet)
  • Aeterna the latest company to report trial delays brought on by Russia’s war in Ukraine (Fierce)
  • Canadian Pfizer partner sues to head off patent lawsuit over COVID-19 vaccine (Reuters)
Coronavirus Pandemic
  • The Covid-19 vaccine market is getting crowded — as demand begins to wane (STAT)
  • South Korea to buy 10 million doses of SK Bioscience's COVID vaccine (Reuters)
  • AstraZeneca COVID drug neutralises Omicron sub-variants in lab study (Reuters)
  • French HAS health authority recommends second Covid-19 booster jab for older people with health risks (Reuters)
  • Moderna to supply additional 7 million doses of COVID booster vaccine to Switzerland (Reuters)
Pharma & Biotech
  • Considerations For Using Established Versus Novel Endpoints In Decentralized Trials (The Pink Sheet)
  • Sanofi Seeks Independence For API Unit Despite Stormy Market (Scrip)
  • Bavarian Nordic Deal Opens Up Potential China Market For RSV Vaccine (Scrip)
  • Pfizer CEO to haul in almost $50M in compensation in 2021 and 2022 (Endpoints)
  • ImmunoGen’s ovarian cancer comeback not as rosy as expected as progression-free survival lags (Endpoints)
  • Teva CEO Kåre Schultz brought home $14.7M last year, soaring past some of Europe's top-paid pharma execs (Endpoints)
Medtech
  • Compliance Corner: 4 Things You Should Do Now To Prep For FDA’s New QMSR Reg (MedTech Insight)
  • FMC's US division Health Partners in $2.4 bln three-way merger (Reuters)
  • Workshop Offers Glimpse At Future Of Hospital 3D Printing (MedTech Insight)
  • MIT, Mass General researchers develop handheld robot for tapping into blood vessels (Fierce)
  • Money flows into addiction tech, but will it curb soaring opioid overdose deaths (Fierce)
  • Minute Insight: First Live Images Of Alpha-Synuclein Raise Hope For Improved Neurological Diagnostics (MedTech Insight)
Government, Regulatory & Legal
  • New Patent Battles Emerge Over What Lipid Technology Is Used In mRNA COVID-19 Vaccines (The Pink Sheet)
  • Illumina sues Guardant Health, claiming founders stole cancer testing trade secrets (Fierce)
  • Becton, McKesson, Cardinal Win Antitrust Appeal Over Syringes (Bloomberg)
  • Bad Bargain? Old Opioid Deal Haunts Fla. AG As Trial Nears (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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