RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2022 > 3 > Recon: Novavax plans 2B Nuvaxovid doses this year; Biden keys in on Medicare drug prices in State of

Recon: Novavax plans 2B Nuvaxovid doses this year; Biden keys in on Medicare drug prices in State of the Union

Posted 02 March 2022 | By Joanne S. Eglovitch 

Recon: Novavax plans 2B Nuvaxovid doses this year; Biden keys in on Medicare drug prices in State of the Union

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novavax doubles down on promise to produce 2B Nuvaxovid doses — this year (Endpoints)
  • Biden Says ‘Top Priority’ Is Getting Prices Under Control (Bloomberg) (Endpoints) (The Pink Sheet)
  • FDA slaps hold on Finch’s C. diff med to get info on COVID-19 screening for donor-derived therapy (Fierce) (Endpoints)
  • FDA quickly follows a voluntary pause for CAR-T 2.0 with a clinical hold to investigate 2 patient deaths (Endpoints)
  • Pfizer's bacterial infection vaccine fails main goal in study (Reuters)
  • NIH orders sweeping review of potentially risky experiments on viruses and other pathogens (The Washington Post)
  • How Operation Warp Speed clashed with Pfizer in the early days of the pandemic (Endpoints)
  • Progressives Press for More Changes to Medicare Payment Program (Bloomberg)
In Focus: International
  • EMA Begins Setting Up New Bodies To Tackle Drug Shortages (The Pink Sheet)
  • UK Offers To Help ‘Innovation Passport’ Holders Tackle Market Access Challenges (The Pink Sheet)
  • Europe's Generics Industry Takes Action To Maintain Medicines Access In Ukraine (The Pink Sheet)
  • In Difficult Times For AAV Gene Therapies, AbbVie Boosts Regenxbio’s Ambitions (Scrip)
Coronavirus Pandemic
  • Weaker Omicron variant is great news for the world, but bad news for Covid-related clinical trials (Endpoints)
  • CDC data suggest Pfizer vaccine protection holds up in kids 5-11, raising questions on earlier study (STAT)
  • Nerve damage may explain some cases of long COVID -U.S. study (Reuters)
  • White House unveils new plan to move America past covid crisis, says shutdowns, school closures no longer necessary (Washington Post)
  • Pfizer to provide 10 mln courses of COVID pill to developing countries -the Global Fund (Reuters
Pharma & Biotech                                                      
  • Pfizer joins Sanofi on the C. difficile failure train after its vaccine flopped a PhIII study (Endpoints)
  • Sanofi enlists Adagene and its 'masking' tech to develop new I/O drugs, in a deal potentially worth $2.5B (Endpoints)
  • 3 burning questions spurred by the big CRISPR patent ruling (STAT) (Biopharma Dive)
  • The Family Dollar Inspection Report: How Not To Handle A Rodent Problem (The Pink Sheet)
  • As GSK is forced to slam the brakes, Pfizer cruises ahead with a ‘breakthrough’ on RSV (Endpoints)
  • Vesalius Therapeutics launches to develop treatments for common diseases (STAT)
  • That bullish stance Karyopharm took on its subgroup cancer study data? The FDA wasn't impressed (Endpoints)
  • Flagship's latest boast? A startup that will 'revolutionize treatment' for 'ninety percent of human illness' (Endpoints)
  • SEC jumps into the FibroGen fiasco with a subpoena, probing cardio data manipulation (Endpoints)
  • IVD Expert Panel: First 15 Reviews Performed With Many Requests For Additional Information (MedTech Insight)
  • FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine (Fierce)
  • QMSR Quick Take: Medtech Consultant Steve Silverman (MedTech Insight)
  • FDA Warns Against Use Of 3 Unapproved COVID-19 Tests (MedTech Insight)
  • Sanofi strikes $30M strategic agreement with digital health company DarioHealth (MedTech Dive)
  • Quanterix links up with Eli Lilly for Alzheimer’s blood biomarker testing collaboration (Endpoints)
  • Zimmer Biomet completes spinoff of ZimVie spine, dental business (Fierce)
Government, Regulatory & Legal
  • Tennessee judge sanctions Endo for withholding opioid documents, refuses to recuse himself from case (STAT)
  • Purdue Pharma mediator extends talks to resolve Sackler liability for opioid epidemic  (Reuters)
  • 3 Product Liability Highlights from The State of The Union (Law360)
  • High Court Poised to Make DOJ's Job Harder in Opioid Cases (Law360)
  • Supreme Court debates exactly when a doctor’s misprescribing becomes criminal (STAT)
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.


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.