Recon: Democrats cobble together drug pricing deal; WHO grants emergency use listing to Bharat Biotech's COVID vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Democrats Add Drug Cost Curbs to Social Policy Plan, Pushing for Vote (NYTimes) (STAT)
- Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial (The BMJ)
- U.S. begins vaccinating its youngest against COVID-19 (Reuters)
- CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11 (STAT)
- With two new insurance partnerships, EQRx takes its first steps toward lowering drug prices. But how big are those steps? (STAT)
- Lilly pulls COVID-19 treatment from EU review while U.S. stocks up (Reuters)
- Indian home-grown COVID-19 shot wins WHO emergency use approval (Reuters)
- India's Bharat Biotech gets regulatory nod for shelf-life extension of its COVID-19 shot (Reuters)
- Italy recommends Pfizer or Moderna booster for those who had J&J shot (Reuters)
- EU antitrust decision on Thermo Fisher's PPD deal due by Dec. 7 (Reuters)
- Analysis: Country by country, scientists eye beginning of an end to the COVID-19 pandemic (Reuters)
- BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency (Pink Sheet)
- Cystic fibrosis group partners with Moderna founder to find better, potentially curative treatments (BioPharmaDive) (Endpoints)
- US FDA Program Adds Staff, Graduation Concept To Help Advance Newer Manufacturing Technologies (Pink Sheet)
- Incyte investigates all batches of new eczema cream Opzelura after reports of 'texture problem' (Fierce)
- Breakthrough status given to Renew Bioscience’s Alzheimer’s treatment (Pharmafile)
- Merck will support Saudi Arabia effort to build biologics manufacturing operations (Fierce)
- CVS Health beats on earnings, gets lift from Covid vaccines and prescription volumes (CNBC) (Reuters)
- CRISPR Therapeutics co-founder uncloaks an off-the-shelf cell therapy startup with $86M and a lot of fanfare (Endpoints)
- Weeks into first approval, Cara waves goodbye to founding CEO in favor of board member (Endpoints)
- Antios Therapeutics' hep B candidate gets another round of applause from investors, closing out a $171M megaround (Endpoints)
- Going after Huntington's disease again, ex-Teva R&D chief gets some cash for Prilenia's renewed efforts (Endpoints)
- Bayer backs a George Church spinout trying to turn lab-invented amino acids into a new class of protein therapies (Endpoints)
- Sage changes primary endpoint in key study months after analysts fret about depression drug's durability (Endpoints)
- Amgen spotlights preclinical 'multi-specifics' as analyst predicts late-stage M&A (Endpoints)
- Boston Scientific wins $20M patent infringement case against Nevro over spinal cord stimulators (Fierce)
- Outset nabs first CMS home dialysis add-on payment, setting up fight with Fresenius (MedtechDive)
- EU’s Updated Plan Of Action To Plug The IVDR Gaps: All Hands To The Pump (MedtechInsight)
- Taiwanese Pharma Co. Can't Shake AOP Sanction Bid (Law360)
- Buyers Win Backing For Narrow Market In Zetia Generic Suit (Law360)
- Generic-Drug Co. Wants Gout Drug Antitrust Suit Tossed (Law360)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
