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)
- 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)
- 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)
- Abbott recalls Heartmate LVAD communication system (MedTech Dive)
- 3M names William Brown CEO (MedTech Dive)
- 3M’s board approves health spinoff (MedTech Dive)
- 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)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
