Recon: US appeals court allows limited access to abortion pill; Novo pens $2.6B deal with cell therapy maker Aspect Biosystems

• Otsuka/Lundbeck’s Rexulti Appears Effective For Alzheimer’s Dementia Agitation, US FDA Says (Pink Sheet) (Fierce) (Endpoints)
• Appeals Court Allows Limited Access to Abortion Pill (Bloomberg) (Endpoints) (Reuters)
• DOJ to ask Supreme Court to put abortion pill limits on hold (APNews) (Endpoints)
• Biopharma Companies – But Not PhRMA – Argue That Mifepristone Ruling ‘Radically Alters’ NDA Process (Pink Sheet)
• Merck’s BTK Inhibitor Evobrutinib Slapped with Partial Clinical Hold (BioSpace)
• White House designates xylazine, better known as ‘tranq,’ as an emerging drug threat (STAT) (Bloomberg) (Washington Post)
• FDA staff leaned toward rejecting Sarepta gene therapy before top official intervened (STAT) (Reuters)
• US FDA Gene Therapy Review Reorg Draws Congressional Interest (Pink Sheet)
• Sanders plans to haul in insulin executives to testify in Senate (STAT)
• 6,000, 7,000, 10,000? Why Counting Rare Diseases Is So Difficult (Pink Sheet)
• Sickle cell gene therapies could be cost-effective even if priced as high as $1.9 million (STAT)

• Moderna’s mRNA Cancer Vaccine Secures EMA PRIME Designation (Pink Sheet) (PharmaTimes)
• Large European study underlines power of genomic sequencing to diagnose diseases (STAT)
• Japan Lays Out New Antibiotics Plan As It Addresses Resistance Issues (Pink Sheet)
• Australian HTA Review Begins In Earnest With Open Consultation (Pink Sheet)
• Ghana first to approve Oxford’s malaria vaccine (Reuters) (Endpoints)

• Novo Nordisk taps into Canadian biotech’s cell therapies for diabetes and obesity in deal worth up to $2.6B (Endpoints)
• Novavax cut $50 million in costs, plans to slash more, CEO says (Reuters)
• Biotechs see ‘staggering’ 87% rise in layoffs during Q1, on pace to overtake 2022 (Fierce)
• Biopharma venture funding falls to the lowest total since 2019 as startups ponder alternative paths (Endpoints)
• Vertex/CRISPR’s gene editing therapy cost effective at $1.9 million – pricing review group (Reuters)
• Pfizer signs strategic cooperation pact with China’s Sinopharm (Reuters)
• Korea’s UNDBIO earmarks $100M to build insulin plant in West Virginia (Fierce)
• Newly merged manufacturers Meridian, Kindeva invest $100M in Missouri site (Fierce)

• Medtronic lays off 59 workers amid closure of Silicon Valley-area facility (Fierce)
• TEAM-NB Survey Shows Slow But Promising Progress Towards MDR/IVDR Certification (MedTech Insight)
• Moximed struts to FDA approval for knee shock absorber implant (Fierce)
• Reach Neuro’s spinal cord stimulator nets FDA breakthrough tag for restoring arm movement after stroke (Fierce)
• UK Rolls Out Genetic Testing Program For Lynch Syndrome In Cancer Prevention Push
• (MedTech Insight)
• In response to ouster, fired Cutera execs sue medtech company, hit back at board members (Endpoints)
• Activist investor Icahn calls for Illumina CEO to be voted off company over Grail deal (Fierce) (Medtech Dive)
• Wireless pacemakers may work for children with slow heart rhythms — but first, doctors need child-sized catheters (STAT)

• GSK argues against taking Teva 'skinny' label suit to SCOTUS (Endpoints) (Fierce) (Bloomberg)
• Teva, Viatris win U.S. appeal in patent fight over Parkinson’s drug (Reuters)
• Purdue Patents for Extended-Release OxyContin Nixed in Intas Win (Bloomberg)
• Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation (Fierce)