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Recon: FDA approves Apellis’ eye disorder drug Syfovre; Pfizer pulls participants from Lyme disease trial over GCP issues

ReconRecon | 20 February 2023 |  By 

Recon: FDA approves Apellis’ eye disorder drug Syfovre; Pfizer pulls participants from Lyme disease trial over GCP issues

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA approves first treatment for leading cause of blindness in older people (STAT) (BioSpace) (Endpoints) (Fierce)
  • U.S. FDA approves Travere Therapeutics kidney disorder drug (Reuters) (STAT) (Endpoints) (BioSpace)
  • Astellas has menopause accelerated approval ambition thwarted by FDA at last minute (Fierce)
  • FDA accepts Iveric Bio's NDA, grants priority review for GA drug (Endpoints)
  • Califf Sees Potential For New Emergency Use Authorities But Concerned About Industry Follow Through (Pink Sheet)
  • Gene Therapy: Years After Accelerated Approval, Will US FDA Still Be Asking ‘Does It Work?’ (Pink Sheet)
  • U.S. to select 10 costliest drugs for Medicare pricing negotiation (Reuters)
  • Ginkgo chief Jason Kelly is chairing a federal biotech advisory group. Is that a conflict of interest? (STAT)
  • Daiichi Sankyo gets US patent office to restart review of Seagen patent (Endpoints)
In Focus: International
  • UK could allow reciprocal drug approvals with US FDA as soon as 2024 (Endpoints)
  • German Ratification Triggers Countdown To Europe’s Unified Patent Court (Pink Sheet)
  • Go Global Or Stay Home? Geopolitics, Funding Crunch May Force China Biotechs To Choose (Pink Sheet)
  • French court hands Novartis and Roche another win in battle over antitrust allegations involving eye drug (STAT) (Endpoints)
  • Denmark reports two more multiresistant bacteria cases from Dicillin (MedWatch)
  • Finland Sees Progress On Biosimilar Substitution Plans (Pink Sheet)
Pharma & Biotech
  • Pfizer scraps half of participants in Lyme disease drug trial due to quality issues (STAT) (Endpoints) (BioSpace)
  • BioNTech sees UK trials on cancer vaccines starting this year, paper says (Reuters)
  • Moderna Falls as Flu Shot Final-Stage Trial Gives Mixed Results (Bloomberg)
  • Novartis names Firmenich CEO as chairman designate of Sandoz (Reuters)
  • Merck seeks more approvals for infectious disease drug (Endpoints)
  • Kite CEO Christi Shaw to depart Gilead CAR-T unit (Endpoints)
  • FDA's No. 2 oncology official departs for biotech startup (Endpoints)
  • ‘It’s the right call’: GSK expresses no regrets on abandoning cell therapy as oligo strategy heats up (Fierce)
  • Christi Shaw, leader of Gilead’s cancer cell therapy unit, to depart (STAT)
  • Pharma should start getting versed in meta (Fierce)
Medtech
  • Momentum Towards UK Medtech Regulatory System Structures Increases (MedTech Insight)
  • Another Notified Body Designation Coming Down The Line Under The EU MDR (MedTech Insight)
  • How Can The EU Get Clinical Evaluations For High-Risk Devices Right? (MedTech Insight)
  • Total Number Of IVD Regulation Designations Reaches 10 (MedTech Insight)
  • BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software (Fierce)
  • Philips recall of 21K previously recalled, repaired ventilator nets FDA Class I tag (Fierce)
  • Baxter spinoffs move forward as three execs made group presidents in new business structure (MedTech Dive)
Government, Regulatory and Legal
  • Abbott Reports Deeper Government Scrutiny Over Formula Shortage (Bloomberg)
  • Moderna’s Patent Case Immunity Argument ‘Flawed,’ Alnylam Says (Bloomberg)
  • Theravance, Viatris Sue to Block Copies of Yupelri COPD Drug (Bloomberg)
  • Ex-Theranos COO Balwani Fights US Over $900 Million Restitution (Bloomberg)
 
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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