rf-fullcolor.png

 

March 12, 2024
by Jason Scott

Recon: Pfizer’s Adcetris shows promise in phase 3 blood cancer study; FDA reviewers raise concerns about Geron's blood disorder drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • When did Wall Street sour on Lilly’s Alzheimer’s drug? (STAT)
  • Pfizer's blood cancer therapy Adcetris succeeds in late-stage trial (Reuters)
  • US FDA staff raises concerns on Geron's blood disorder drug (Reuters)
  • The R&D 15: Top pharma players shell out record $153B for research, and M&A is a prime focus for all (Endpoints)
  • US officials urge UnitedHealth to expedite payments to providers (Reuters)
  • Why Cigna is capping cost increases for pricey GLP-1 weight loss drugs (MedTech Dive)
In Focus: International
  • Novo Nordisk-owner to expand in India this year (Reuters)
  • UK Competition Watchdog Attacks Tribunal As Hydrocortisone Fines Overturned (Pink Sheet)
  • UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look (Pink Sheet)
  • EU’s DARWIN Project To Expand Geographical Reach With 10 New Data Partners (Pink Sheet)
Pharma & Biotech
  • Acadia’s Nuplazid fails as treatment for schizophrenia in Phase 3 study (STAT)
  • First medicine developed to treat MASH expected to be approved soon (STAT)
  • Roche is trying again and again in Alzheimer’s. This time, early data are ‘worth watching’ (Endpoints)
  • Merck pens pact with Pearl Bio for new biologics in cancer (Endpoints)
  • MarketingRx roundup: Pfizer, Lilly lead Academy Awards pharma ads; Merz Aesthetics teams with Demi Lovato (Endpoints)
  • From TikTok to the Oscars: How marketing obesity drugs is no longer just the purview of Eli Lilly and Novo Nordisk (Endpoints)
  • Regulus raises $100M; Cancer company files to go public (Endpoints)
  • Ex-Theseus execs extend GIST mission by taking helm of IDRx (Endpoints)
Medtech Government, Regulatory & Legal
  • Former medical device CEO who sold dummy, plastic parts convicted of fraud (STAT)
  • Preventing the weaponization of AI-designed proteins (STAT)
  • UnitedHealth is on a buying spree of outpatient surgery centers (STAT)
  • Company's PO box allows it to file for bankruptcy in Texas, judge rules (Reuters)
  • Rigid rules at methadone clinics are jeopardizing patients’ path to recovery from opioid addiction (STAT)
  • New methadone rules are about to take effect. Here are 6 ways treatment could shift (STAT)
  • Disabled scientists are often left out of academia. The NIH can help change that (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.