Recon: Roche to buy obesity drugmaker Carmot Therapeutics for $2.7B; Supreme Court hears oral arguments in Purdue bankruptcy case
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing (Fierce)
Lawmakers want to know why it took the FDA so long to rule on decongestant phenylephrine (Fierce) (Endpoints)
Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says (Pink Sheet)
US Supreme Court grapples with Purdue Pharma bankruptcy settlement case (Reuters)
Explainer: How will the Supreme Court reshape US opioid epidemic relief? (Reuters)
A well-meaning FDA policy is a threat to pediatric cancer treatment (STAT)
Lilly's Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing (Fierce Pharma)
In Focus: International
Bigger Trials, More RWE Needed for Future Crisis Response, Say EU Regulators (Pink Sheet)
EMA Requests More Data from GLP-1 Drugmakers in Suicidal Ideation, Self-Harm Probe (BioSpace)
French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine (Pink Sheet)
Premature Filings Add To EU Regulatory Resource Challenge (Pink Sheet)
Novartis is building a new radioligand plant in China (STAT)
Novartis unveils new brand identity after Sandoz spinoff (Endpoints)
India finds quality issues with cough syrup linked to Cameroon deaths – sources (Reuters)
WuXi Biologics’ stock slides by 24% as manufacturing business slows amid biotech downturn (Endpoints)
South Africa's Aspen expands reach with $100M buy of Sandoz's Chinese business (Fierce Pharma)
NASH market fattening up as wait for liver treatments drags on (Fierce Pharma)
Pharma & Biotech
Roche to acquire obesity-focused Carmot Therapeutics for $2.7 billion (STAT) (Fierce)
How sickle cell became the first disease treated by CRISPR (STAT)
Up and down the ladder: The latest comings and goings (STAT)
As Bayer confronts mounting Roundup losses, all eyes on Philadelphia trial (Reuters)
Wet AMD biotech stock soars over 200% as lead asset matches Regeneron’s Eylea in PhII test (Endpoints)
Seismic raises $121M to enter immunology space spotlighted by argenx, Immunovant and others (Endpoints)
Abbisko signs $70M upfront deal with Merck KGaA for PhIII cancer drug (Endpoints)
Orna Therapeutics trims staff in ‘defensive reduction’ despite large financing hauls (Endpoints)
Exclusive: San Diego biotech raises $11.7M to use cells as targeted delivery vessels for genetic medicines (Endpoints)
Medtech
European Commission Launches Data Collection Initiative To Avoid Medtech Product Shortfalls (MedTech Insight)
Member States Want Action Over High-Risk IVDs And Eudamed Medical Device Database (MedTech Insight)
FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close (MedTech Insight)
Johnson & Johnson bets heavy on AI-driven drug discovery (STAT)
UCSF scientists aim to unravel autism with brain organoids and AI (Endpoints)
AstraZeneca inks $247M deal with generative AI shop Absci to develop antibody drug for cancer (Endpoints)
Nevro buys low back pain company Vyrsa for $40M (MedTech Dive)
Resmed’s new C-suite focused on growing sleep apnea device demand: analysts (MedTech Dive)
BD tells customers not to use Cardinal’s Monoject syringes with Alaris pumps (MedTech Dive)
Government, Regulatory & Legal
Big Weed today is a whole lot like Big Tobacco in the 1950s (STAT)
STAT readers on burnt-out infectious disease doctors, 12-month prescriptions, and counting disabled Americans (STAT)
CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program (FDA Law Blog)
Veteran Big Pharma chief lashes out at Tucker Carlson, Elon Musk’s drug ad criticism on X (Fierce Pharma)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.