Recon: FDA to convene adcomm for twice-rejected ALS cell therapy; EU delays pharma legislation for third time

• 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)

• 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)

• 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)

• 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)

• 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)