Regulatory Focus™ > News Articles > 2021 > 10 > Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Me

Posted 15 October 2021 | By Michael Mezher 

Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

2793 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • U.S. FDA advisers to vote on J&J vaccine booster (Reuters)
  • FDA advisers back Moderna COVID booster shots for older and high-risk people (Reuters) (NYTimes)
  • Abbott Labs unit recalling two COVID-19 lab test kits – FDA (Reuters)
  • As suits mount, J&J spins out talc liabilities into Chapter 11 using 'Texas two-step' maneuver (Endpoints) (FT)
  • FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment (FDA)
In Focus: International
  • EU, South Africa hold "intense talks" to break vaccine patent impasse (Reuters)
  • Pfizer/BioNTech submit data to EMA for COVID-19 vaccine in young children (Reuters)
  • Bayer, CureVac terminate COVID-19 shot production partnership (Reuters)
  • As Moderna's search for African manufacturing site ramps up, Bancel answers criticism about donations (Reuters)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021 (EMA)
  • Incyte yanks EU application for PD-1 drug, citing inability to answer regulators' 'major concerns' (Endpoints)
  • The European Commission has caved to pressure on extending IVDR. Now what? (MedtechDive)
Coronavirus Pandemic                                                                                                                                       
  • S.Africa to vaccinate teenagers with single dose of Pfizer -health minister (Reuters)
  • Philippines starts COVID-19 vaccinations for 12-17 year olds (Reuters)
  • UK lab suspended after false negative COVID-19 tests (Reuters)
  • Russian 'vaccine tourists' travel to Serbia for Pfizer shot (Reuters)
  • FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19 (PMLive)
Pharma & Biotech
  • Is Robert Califf a savvy choice to helm the FDA — again? (STAT)
  • MD Anderson hit with ethics complaint over failure to disclose clinical trial results (STAT)
  • NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer (PharmaTimes)
  • FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments (FDA)
  • Chinese biopharma powerhouse continues charge into siRNA with Silence R&D pact (Fierce)
  • New data shows Roche's Enspryng significantly reduces neuromyelitis optica spectrum disorder relapses (PMLive)
  • Imfinzi/tremelimumab combo scores AstraZeneca another OS win — this time in liver cancer (Endpoints)
  • Q&A: Tillman Gerngross explains why his Covid mAb will have an edge over an already crowded field (Endpoints)
  • Pharma veterans regroup with $50M and a plan to discover new multi-specifics (Endpoints)
  • A Bob Nelsen startup turns to Harvard to help sharpen its tech, inspiring first spinout (Endpoints)
  • Qiming-backed Abbisko makes $200M+ Hong Kong debut, as a SPAC and Agenus spinout also price on Nasdaq (Endpoints)
  • Novartis development chief John Tsai: 'We go deep in the new platforms' (Endpoints)
  • Hologic dreams bigger for Bolder Surgical with $160M acquisition deal (Fierce)
  • Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA (MedtechDive)
Government, Regulatory & Legal
  • Boehringer Loses Bad Faith Claim In Diabetes Drug Deal Suit (Law360)
  • Purdue Ch. 11 Plan Challenges Won't Hit 2nd Circ. Right Away (Law360)
  • Theranos hired its president’s dermatologist as lab director in 2014, testimony shows (CNBC)
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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