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November 3, 2021
by Michael Mezher

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • Analysis: Country by country, scientists eye beginning of an end to the COVID-19 pandemic (Reuters)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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