RAPS Learning Portal will be under maintenance on 12 June 2026 between 10 PM - 12 AM ET. Learning Portal functionality and profile access may be unavailable during this window.
We apologize for any inconvenience caused during this time.
Trump administration cancels meetings of health technology advisory committee (STAT)
Merck to stop lung condition drug study early due to strong efficacy data (Reuters)
In Focus: International
Takeda CEO Christophe Weber to step down following prolonged drop in company shares (STAT)
Bright Green budgets $3.5B for new builds; European Commission opens biomanufacturing hub (Endpoints)
Is India’s Ban On Imports Of Refurbished Medical Devices Right Move? Industry Debates The Effects (MedTech Insight)
Biocon's Q3 revenue dips; banks on obesity drugs for future growth (Reuters)
Sanofi plans share buybacks, signals more deals post Opella sale (Reuters)
Roche sees high single-digit core profit growth in 2025 (Reuters)
Uganda confirms Ebola case in nurse in capital city (STAT)
Pharma & Biotech
When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities (FDA Law Blog)
Takeda scraps programs as it raises full-year guidance (Endpoints)
Cargo to lay off staff after CAR-T data show safety concerns (STAT)
MASH drugs reach a meaningful tipping point for patients and investors (STAT)
Hims is making its Super Bowl debut with an ad that goes straight for pharma (Endpoints)
Blackstone secures $1.6B so far for new life sciences fund targeted at $5B+ (Endpoints)
Rentschler exits cell and gene business due to low demand, will prioritize biologics (Endpoints)
Ironwood's layoffs; Shionogi’s RSV pill succeeds in Phase 2 (Endpoints)
Tectonic gets Phase 1b win in heart condition where Eli Lilly recently failed (Endpoints)
8VC, a tech and life sciences VC firm behind Altos Labs, eyes $1B fund (Endpoints)
Roche aims for derisked deals and ruthless portfolio cuts in 2025 (Endpoints)
Novo Nordisk says it has not yet posted details about new CagriSema trial (Reuters)
Medtech
Thermo Fisher sees robust 2025 profit on improved demand for its tools and services (Reuters)
Quest beats quarterly estimates on strong diagnostic test demand (Reuters)
What models flourished in the first generation of health tech? (STAT)
How AI helps drug developers skirt pharma’s ‘dirty little secret’ (STAT)
Engineered muscle patch fixed failing hearts in an early study (STAT)
How Define Ventures thinks health tech startups will exit in 2025 (Endpoints)
4 robotic surgery trends to watch in 2025 (MedTech Dive)
23andMe considers sale as cash runs low (MedTech Dive)
What I learned about health insurance rage as the nation’s first ‘HMO czar’ (STAT)
Private emails show RFK Jr. making false claims about Covid-19 shots, linking vaccines to autism (STAT)
Universities fear Trump is using lucrative research grants as leverage to dismantle their DEI programs (Endpoints)
Despite waiver from U.S. on aid freeze, health and humanitarian groups uncertain if they can proceed (Reuters)
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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.