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: House bill proposes changes in FDA’s accelerated approval program for drugs; Novartis signs $

Recon: House bill proposes changes in FDA’s accelerated approval program for drugs; Novartis signs $1.7b option agreement with Voyager Therapeutics

Posted 08 March 2022 | By Joanne S. Eglovitch 

Recon: House bill proposes changes in FDA’s accelerated approval program for drugs; Novartis signs $1.7b option agreement with Voyager Therapeutics

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pallone’s Bill Gives FDA New Power Over Accelerated Approvals (Inside Health Policy) (Endpoints)
  • Moderna plots vaccines against 15 pathogens with future pandemic potential (Reuters) (Bloomberg)
  • After nearly two years of criticism from activists and White House, Moderna unveils a new plan for global health (Endpoints)
  • Valneva heads to FDA as durability of chikungunya vaccine holds up in phase 3 (Fierce)
  • FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds (STAT)
  • J&J regrets paying for study that injected incarcerated Black men with asbestos – report  (Endpoints)
  In Focus: International
  • Kenya wins $500M sweepstakes for Moderna's first African manufacturing site (Endpoints) (Reuters) (BioPharma Reporter)
  • Global Summit Hears Pledges To Cut Pandemic Vaccine Development Times (The Pink Sheet)
  • China's 'Two Sessions': Vaccines, Drugs Seen Key To Easing Restrictions Amid New Spike (The Pink Sheet)
  Coronavirus Pandemic
  • Moderna will never enforce Covid-19 vaccine patents in poor countries (STAT) (Politico)
  • White House Cuts Covid Funding Request to $15B: Senator Blunt (Bloomberg)
  Pharma & Biotech
  • Novartis eyes next-gen AAV gene therapies in $1.75B Voyager biobucks pact (Fierce) (BioPharma Reporter) (Scrip)
  • New Products Shake Up Overlooked Bipolar Disorder Market (Scrip)
  • BioNTech and Regeneron expand their cancer partnership, pushing new Libtayo combo into NSCLC (Endpoints)
  • Pfizer, CytoReason extend AI pact after immune system success (Outsourcing Pharma)
  • After 16 years, BMS' megablockbuster cancer drug finally runs into its first generic competition (Endpoints)
  • With investment from Alloy, Boston peptide manufacturer announces Series A (Endpoints)
  • An AI biotech emerges from stealth promising drugs 'on demand.' What will that 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, colorectal cancers by producing interleukin-2; mouse study (Fierce)
  • Newly discovered brain cells may be a memory filing system, study suggests (STAT)
  Medtech
  • Cionic’s Neural Sleeve Wins FDA Clearance With Planned Launch This Fall (MedTech Insight)
  • Medtech industry condemns Russia's invasion of Ukraine (MedTech Dive)
  • As ortho procedures recover, Stryker turns focus to supply chain (MedTech Dive)
  Government, Regulatory & Legal
  • Cipla Files Preemptive Lawsuit Over Boehringer’s Ofev Patents (Bloomberg)
  • Novo Files Patent-Infringement Suits to Block Ozempic Copies (Bloomberg)
  • Mallinckrodt to pay $260 million to settle federal lawsuits over Medicaid rebates and kickbacks (STAT) (Bloomberg) (Law360)
  • CVS, Walgreens, Walmart Can’t Escape Opioid Verdict (Law360)
  • NY, NJ Towns Fight $277M ‘Hush Money’ In Purdue Deal (Law360)
  • National Vaccine Injury Program Needs Modernizing (Bloomberg)
  • Elizabeth Holmes’s Ex May Hold Her Ticket to Less Prison Time  (Bloomberg)
  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.

Subscribe