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

• 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)

• 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)

• Moderna will never enforce Covid-19 vaccine patents in poor countries (STAT) (Politico)
• White House Cuts Covid Funding Request to $15B: Senator Blunt (Bloomberg)

• 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)

• 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)

• 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)