Recon: US appeals court allows limited access to abortion pill; Novo pens $2.6B deal with cell therapy maker Aspect Biosystems
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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
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- 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)
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