House bill

Recon: House bill proposes changes to FDA’s fast-track drug approval program; Novartis $ sign

Posted on March 08, 2022 | By Joanne S. Eglovitch

Welcome to Regulatory Reconnaissance, your daily update on regulatory news and intelligence.

In brief: United States

  • Pallone’s bill gives the FDA new power over expedited approvals (Internal health policy) (Endpoints)
  • Moderna is preparing vaccines against 15 pathogens with future pandemic potential (Reuters) (Bloomberg)
  • After nearly two years of criticism from activists and the White House, Moderna is unveiling a new plan for global health (Endpoints)
  • Valneva Heads to FDA as Chikungunya Vaccine Durability Holds in Phase 3 (Fierce)
  • FDA efforts to improve clinical trial diversity failed to make a difference for black patients, study finds (STAT)
  • J&J regrets paying for study that injected asbestos into incarcerated black men – report (Endpoints)

Focus: International

Coronavirus pandemic

  • Moderna will never enforce Covid-19 vaccine patents in poor countries (STAT) (Politics)
  • White House cuts Covid funding request to $15 billion: Senator Blunt (Bloomberg)

Pharmaceuticals and biotechnology

  • Novartis eyes next-generation AAV gene therapies in $1.75 billion Voyager biobucks pact (Fierce) (Biopharmaceutical Journalist) (Certificate)
  • New products are shaking up the neglected bipolar disorder market (Certificate)
  • BioNTech and Regeneron expand cancer partnership, pushing new Libtayo combo into NSCLC (Endpoints)
  • Pfizer and CytoReason Extend AI Pact After Immune System Success (Pharmaceutical outsourcing)
  • After 16 years, BMS’ cancer drug megablockbuster finally hits its first generic competition (Endpoints)
  • With investment from Alloy, Boston peptide maker announces Series A (Endpoints)
  • An AI biotech emerges from promising “on-demand” stealth drugs. What will it look like and is it even possible? (Endpoints)
  • Big Pharma veteran Karin Shanahan reunites with Bristol Myers’ supply team after 22 years apart (Endpoints)
  • New pinhead-sized beads kill ovarian and colorectal cancers by producing interleukin-2; mouse study (Fierce)
  • Newly discovered brain cells may be a memory storage system, study finds (STAT)

medical technology

Government, regulation and legal

  • Cipla takes preventive action against Boehringer’s Ofev patents (Bloomberg)
  • Novo files patent infringement lawsuit to block copies of Ozempic (Bloomberg)
  • Mallinckrodt will pay $260 million to settle federal lawsuits over Medicaid rebates and kickbacks (STAT) (Bloomberg) (Law360)
  • CVS, Walgreens, Walmart can’t escape the opioid verdict (Law360)
  • NY, NJ Towns Fight for $277M ‘Hush Money’ in Purdue Deal (Law360)
  • The National Vaccine Injury Program needs to be modernized (Bloomberg)
  • Elizabeth Holmes’ ex could hold her ticket to less time in jail (Bloomberg)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.
Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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