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)
- 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)
- 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)
- 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)
- 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.
