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

ReconRecon | 02 March 2022 |  By 

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)
Medtech
  • 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.

 

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