Recon: Merck’s endometrial cancer treatment falters in study; Novo signs $600M deal with Metaphore to develop new obesity drugs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Lawmakers consider limiting how long existing WuXi contracts can continue (Endpoints)
Merck's endometrial cancer therapy fails trial (Reuters)
Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says (Pink Sheet)
Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says (STAT)
US FDA advises healthcare facilities to switch from Getinge's heart devices (Reuters)
In Focus: International
Novo Nordisk ties up with Metaphore to develop new obesity drugs (Reuters) (Endpoints)
A new cholera vaccine will increase supply, but will it be enough to manage global outbreaks? (STAT)
Japan's Takeda Pharma to restructure after annual profit slump (Reuters)
Drugmaker Abbott India posts Q4 profit rise on higher sales (Reuters)
UK refuses to sign global vaccine treaty, The Telegraph reports (Reuters)
AstraZeneca to withdraw COVID vaccine globally as demand dips (Reuters)
‘Don’t Cut Corners’ If You Want To Succeed, EMA Orphan Drug Head Tells Sponsors (Pink Sheet)
Pharma & Biotech
Cytokinetics set to pitch its heart drug to physicians — and Big Pharma suitors (STAT)
Yet another big financing round in immunology (STAT)
After gene therapy, two congenitally deaf children hear for the first time (STAT)
Acelyrin's founding CEO steps down, company scraps earnings call (Endpoints)
Infectious disease biotech Bluejay raises $182M for hepatitis trials (Endpoints)
Freeline unveils early efficacy signal for Gaucher gene therapy: #ASGCT24 (Endpoints)
Takeda to revamp in multiyear quest, pivots CAR-NK therapy from cancer to autoimmune (Endpoints)
Teva Pharm to launch Humira biosimilar as Q1 profit misses estimates (Reuters)
CytomX shares plummet as Amgen-partnered cancer drug yields jumbled Phase 1 data (Endpoints)
Attovia reels in $105M from crossover investors to run multiple trials of I&I biologics (Endpoints)
Aardvark nabs $85M to target hunger, not appetite, as it eyes 2026 NDA filing (Endpoints)
Danish biotech nabs Novo Holdings support in seed round for complement platform (Endpoints)
Viagra maker Viatris misses revenue estimates on weak demand for older drugs (Reuters)
US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall (Pink Sheet)
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules (Pink Sheet)
Medtech
Tandem reports 224 injuries related to faulty insulin pump app (MedTech Dive)
Samsung Medison to buy AI ultrasound company Sonio (MedTech Dive)
Geneoscopy wins FDA approval for Labcorp-partnered colon cancer test (MedTech Dive)
Integra still addressing problems at Boston plant (MedTech Dive)
Government, Regulatory & Legal
As livestock move around the country, so does H5N1. The U.S. needs real-time tracking of livestock movements (STAT)
H5N1 communication has been strictly for the birds. Didn’t the federal government learn anything from Covid? (STAT)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.