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)
- 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)
- 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)
- 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)
- 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)
- 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)
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