Recon: Boehringer will sell Humira biosimilar at deep discount; WHO recommends second malaria vaccine

• Drugmakers sign on to negotiate Medicare prices under protest (Reuters)
• US Patent Office won't review two Novo Nordisk patents for Wegovy, Ozempic (Reuters)
• Boehringer launches 81% discounted biosimilar of AbbVie's Humira (Reuters)
• Takeda pulls Exkivity in US after failed confirmatory trial (Pharmaphorum)
• Court strikes down Trump-era rule that allowed health insurers to broadly use copay accumulators (STAT)
• FDA Panel Will Have To Weigh Pediatric Cancer Drug’s ‘Higher Level’ Of Uncertainty Against Rare, Devastating Disease (Pink Sheet)
• Novo Files Suit Over IRA As It Joins Others In Signing On To Price Negotiations (Pink Sheet)

• WHO recommends second malaria vaccine, hoping to address supply issues (STAT)
• EU’s Unitary SPC System Must Maximize Access To Medicines & Not Block Generic Entry (Pink Sheet)
• ‘Close The R&D Gap’ Between EU & Other Regions, EFPIA Tells Lawmakers (Pink Sheet)
• Mexico Continues Reliance Strategy To Expand Drug Access (Pink Sheet)

• Lilly bolts another one on, acquiring Point Biopharma for $1.4 billion (STAT)
• FDA finds ‘potential systemic bias’ in Amgen’s KRAS drug trial ahead of advisory meeting (STAT)
• When is a Wall Street disappointment ‘good enough’ for the FDA? (STAT)
• How headlines about the RSV antibody injection could cloud parents’ decision-making (STAT)
• Novo Nordisk owner readies for big Wegovy windfall (Reuters)
• Sanofi in agreement with Janssen to develop E. coli the vaccine candidate (Reuters)
• Amgen's late-stage data for lung cancer drug 'not adequate' - FDA staff (Reuters)
• Bristol Myers notches diversity gains after revamping its clinical trial location strategy (Endpoints)
• BridgeBio partners with biomanufacturer Resilience to produce early-stage AAV gene therapies (Endpoints)
• Exscientia ends cancer study as it focuses on other trials of AI-driven drug candidates (Endpoints)

• AI-driven biotech Iambic snags $100M to enter the clinic next year in HER2 field (Endpoints)
• Invitae test for hereditary cancers gains FDA de novo nod (MedTech Dive)

• AstraZeneca Pays $425 Million in Nexium, Prilosec Settlement (Bloomberg)
• Pfizer’s Diversity Fellowship Under Scrutiny at Second Circuit (Bloomberg Law)
• Congress extends some pandemic preparedness programs, but not all (STAT)
• Court tosses $223.8 million verdict against J&J in talc cancer case (Reuters)
• FDA expands total product life cycle program to cover neurological devices (MedTech Dive)
• Stakeholders Give FDA An Earful About Poor Communication, Recall Inefficiency, Putting Patients At Risk (MedTech Insight)
• Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List) (FDA Law Blog)