Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

ReconRecon | 22 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna booster candidate shows strong response against Omicron subvariants (Reuters)
  • Moderna CEO: COVID variant vaccine to be ready for shipping in August (Reuters)
  • Omicron-specific COVID vaccines on the horizon, Pfizer chief says (Reuters)
  • More vulnerable people receiving fewer COVID pills - U.S. study (Reuters)
  • FDA to Order Juul E-Cigarettes Off U.S. Market (WSJ) (Reuters)
  • FDA Aims to Cut Down on Smoking by Slashing Nicotine Levels in Cigarettes (NYTimes) (FDA)
  • Supreme Court rules against DaVita over dialysis coverage (Reuters)
  • Schumer will put legislation to cut insulin costs on Senate floor 'very soon' (Reuters)
  • Biden picks former DARPA director Prabhakar as next science adviser (STAT) (Endpoints)
  • Pfizer sued for patent infringement over COVID-19 drug Paxlovid (Reuters)
In Focus: International
  • EU to boost investment in Latin American vaccine, drug production (Reuters)
  • EQT's Galderma announces positive trial results on skin drug (Reuters) (Endpoints)
  • COVID-19 vaccine scheme for world's poorest pushes for delivery slowdown (Reuters)
  • Moderna to build new vaccine facility in Britain (Reuters) (FT)
  • Biotechs face ‘funding Sahara’ as easy money runs dry (FT)
Pharma & Biotech
  • Galapagos finally takes M&A plunge, spending $251M for 2 biotechs in CAR-T push (Fierce) (Endpoints)
  • Merck, Sanofi join Novartis’ 10-year quest to improve clinical trial diversity as historically Black colleges pitch in (Endpoints)
  • Takeda to further cement presence in Cambridge, MA biopharma hub with 600,000-square-foot R&D center (Endpoints)
  • Novartis hunting for sickle cell cure with Precision deal (BioPharmaDive) (Endpoints)
  • Game on, Pfizer: Merck's Vaxneuvance boosts pneumococcal vaccine fight with coveted pediatric nod (Fierce)
  • Athira’s alternative Alzheimer’s approach runs into a PhII brick wall (Endpoints)
  • AbbVie walks away from Morphic deal in aftermath of safety signal in preclinical testing (Endpoints)
  • NICE opts to reject Acorda’s MS drug Fampyra (PharmaTimes)
  • Merck scoops up new chief marketing officer from Biogen's neurology business (Endpoints)
  • Doudna research team finds CRISPR-Csm delivery potentially outperforms RNAi, Cas13 (Endpoints)
  • FDA adds Class I tag to Dräger’s recall of 36K ventilator filters (Fierce)
  • FDA opens consultation on tissue removal devices to reduce cancer risk (MedtechDive)
  • Medtronic reinforces spine surgery portfolio with FDA nod for ligament-augmenting implant (Fierce)
  • GE Healthcare debuts wireless, wearable hospital patient monitor (Fierce)
Government, Regulatory & Legal
  • Fraud trial against Elizabeth Holmes’ partner at Theranos nears end (CNBC)
  • Two Florida Men Charged With Profiting Off Fake Prescriptions (NYTimes)
  • Philips Knew Of CPAP Foam Issues In 2015, Device Users Say (Law360)
  • Senate lawmakers introduce a bill to help the FDA and the U.S. Patent Office coordinate (STAT) (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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