Recon: FDA to convene adcomm for twice-rejected ALS cell therapy; EU delays pharma legislation for third time
In Focus: US- Under protest, FDA to convene advisory panel to review controversial cell therapy for ALS (STAT) (BioPharma Dive)
- Pharming’s Leniolisib Gains FDA Approval in Ultra-Rare Disease (BioSpace)
- Indian generic drugmaker to launch Leo Pharma copycat drug in US (MedWatch)
- Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza (Pink Sheet)
- iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements (Pink Sheet)
- California’s Plan for Cheaper Insulin Collides with Big Pharma’s Price Cuts (NYT) (MedWatch)
- The surprising biomedical legacy of the Iraq War (STAT)
- Federal Workers Win Order Blocking Biden’s Covid Vaccine Mandate (Bloomberg)
- Senate committee advances PBM bill as bipartisan reforms gain traction (Endpoints)
In Focus: International
- EU delays new drug law proposal (MedWatch) (STAT)
- European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation (Pink Sheet)
- EU Guide Outlines Important Considerations For Submitting Complex Trials In CTIS (Pink Sheet
- EU Crunch Time For Mirikizumab, New Covid-19 Vaccine & Other Drugs (Pink Sheet)
- Production at contaminated CMO continues – authorities deny further risks (MedWatch)
- European doctors dial up digital communication with pharmas, but still lean toward in-person med meetings, study finds (Endpoints)
Pharma & Biotech
- Cash-rich BioNTech plans to spend about $1 bln more on research this year (Reuters)
- Novartis buoyed by trial success in early-stage breast cancer (Reuters) (BioSpace)
- Lyme vaccine test completion is pushed back by a year as Pfizer, Valneva say they'll adjust trial (Endpoints)
- Top 10 pharma R&D budgets in 2022 (Fierce)
- Novo Nordisk pens $745M biobucks pact with Dewpoint to tackle insulin resistance, diabetes complications (Fierce)
- Novo Nordisk reaches primary endpoint in phase III study to oral semaglutide (MedWatch) (Fierce)
- New data give Agenus’ combo drug another boost, this time in ovarian cancer (Fierce)
- Q&A: BioCina’s new CEO Mark Womack on the CDMO he says is 'worth traveling over' (Endpoints)
- Vertex and CRISPR Therapeutics Announced Licensing Agreement to Accelerate Development of Vertex’s Hyperimmune Cell Therapies for the Treatment of Type 1 Diabetes (BioSpace)
- Gamida lays off 17%, ditches NK cell therapy work to keep blood cancer drug on track (Fierce)
- Sanofi, Regeneron’s Dupixent could hit $20B in peak sales with COPD expansion: analyst (Fierce)
- Finch pinches pennies, stretching cash to 2025 after layoffs and trial discontinuation (Fierce)
- Relmada, reeling from 2 late-phase flops, plots comeback for depression drug (Fierce)
- Codiak files for Chapter 11 bankruptcy as most executives head for the exit (Endpoints) (Reuters)
Medtech
- Neuromodulation device for PTSD treatment from GrayMatters snags FDA nod (Fierce)
- Musk’s brain implant company in search of human trials partner (Reuters)
- FDA Faults Next-Gen Olympus Duodenoscopes (MedPage Today)
- BSI Notified Body Highlights Crucial Elements Related To EU’s MDR Amending Regulation (MedTech Insight)
- Icahn says Illumina directors got personal insurance after Grail deal (MedTech Dive)
Government, Regulatory and Legal
- U.S. Supreme Court hears Amgen bid to revive cholesterol drug patents (Reuters)
- Judge allows expert testimony in GSK trial alleging Zantac link to cancer (Endpoints)
- AbbVie, Merz’s 454.5 Million Settlement in Namenda Suit Approved (Bloomberg)
- J&J Unit Wins Dismissal of Tylenol ‘Rapid Release’ False-Ad Suit (Bloomberg)
- Target Lidocaine ‘Maximum Strength’ False-Ad Suit moves Forward (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.
