Recon: Novartis loses patent appeal for MS drug Gilenya; European Commission investigates Vifor for anticompetitive practices

ReconRecon | 21 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 'Put up or shut up': Biden, Dems have one last chance to resurrect drug pricing reforms ahead of elections (Endpoints)
  • Medicare could have saved billions on drugs if it paid what Mark Cuban charges at his new pharmacy (STAT) (Endpoints)
  • Merck touts new data for breakthrough pneumococcal vaccine as it heads to PhIII trials (Endpoints)
  • U.S. Supreme Court rebuffs UnitedHealth Group challenge on Medicare overpayments (Reuters)
  • Novartis loses in patent appeal over multiple sclerosis drug (Reuters)
  • U.S. COVID vaccine rollout for young children will pick up pace (Reuters)
In Focus: International
  • AstraZeneca, Ionis eye U.S. approval after positive trial data (Reuters) (Endpoints)
  • PTC’s Duchenne muscular dystrophy drug achieves study goal, potentially confirming European approval (STAT)
  • European Commission investigates Vifor for ‘disparaging’ its only rival in iron deficiency market (STAT) (EC)
  • European researchers seek greater stake in drug development in bid to improve access (STAT)
  • Biocon denies allegations it bribed Indian regulator to waive diabetes drug's pivotal trial  (Fierce) (Times of India)
  • Some Omicron sub-variants escaping antibodies from Sinopharm shot, Chinese study says (Reuters)
Pharma & Biotech
  • Center for Breakthrough Medicines plans for an even larger dive into cell therapy manufacturing (Endpoints)
  • Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer (Endpoints)
  • 15 leaders giving voice and visibility to the LGBTQ community in biopharma (Endpoints)
  • Carbon Biosciences emerges with a new viral vector to shake up the cystic fibrosis gene therapy field (Endpoints)
  • U.S. factories pop up to make medical gloves, spurred by pandemic (Reuters)
  • Devicemaker MicroTransponder raises $53M and more digital health fundings (MobiHealthNews)
  • Cardio Catch-Up: Updates From B-Secur, Egnite, Vektor, And Other Under-The-Radar Companies (MedtechInsight)
  • How a sports apparel company helped one Virginia health system pivot to reusable gowns (MedtechDive)
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.
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