Recon: Will labs sue US FDA over LDT proposed rule? EU Rapporteur slams commission’s proposals

• Former FDA Chief Counsel Expects Lawsuits Over Agency's LDT Proposal (MedTech Insight)
• FDA rejects Alnylam’s heart disease treatment over insufficient data (STAT)
• NIH funds research for three experimental ALS drugs (BioPharma Dive) (STAT)
• FDA panel finds KRAS drug data unreliable, in blow to Amgen (BioPharma Dive)

• Medtech Could Help Address EU’s Worsening Healthcare Workforce Crisis (MedTech Insight)
• EU regulatory order for Illumina to sell Grail could come next week – FT (Reuters)
• Orchard sells to Kyowa Kirin in gene therapy buyout (BioPharma Dive)
• GSK taps Chinese partner to ramp up Shingrix sales in $3.05B deal, with option to expand to RSV (Endpoints News)
• Gates gives $40 mln to boost access to mRNA vaccines in Africa (Reuters)
• UK Regulator On Using The New International Reliance Procedure To Encourage Filings (Pink Sheet)

• EU Rapporteur Slams Commission’s ‘Regulatory Sandbox’ & Antimicrobial ‘Voucher’ Proposals (Pink Sheet)
• Moderna claims positive results in early study for combo COVID, flu shot (BioPharma Dive)
• Vertex CSO David Altshuler talks non-opioid pain pills, AI and the myth of breakthroughs (Endpoints News)
• Lilly says about 70% of patients taking tirzepatide experienced an adverse event (Endpoints News)
• Off-Patent Industry Proposes Extensions To EU Market Protection Rather Than Data Exclusivity (Pink Sheet)

• UK IVDs Industry To See Renewed Impetus Under Incoming BIVDA Chief Dent (MedTech Insight)
• Labcorp buys Baystate’s outreach lab business, furthering consolidation blitz (MedTech Dive)
• Medtronic hires neuromodulation president from Smith+Nephew (MedTech Dive)
• UK Virtual Wards Get Boost From £30m Medtech Funding For Integrated Care Systems (MedTech Insight)

• California Governor Vetoes Law Capping Monthly Insulin Costs (Bloomberg Law)
• Obesity Drugs: Jury's Still Out On Potential US Health Care Savings, CBO Says (Pink Sheet) (Endpoints News)
• Discounts for weight loss drugs are estimated at more than half, fueling questions about price, PBMs and coverage (Endpoints News)
• Judge dismisses Novo Nordisk lawsuit over compounded versions of Ozempic and Wegovy (STAT)
• Pharma Could Lose Some Commercial Info Protections As Part of FDA’s Misinformation Campaign (Pink Sheet)
• EU Parliament Report Calls For Nine-Year Data Protection Period (Pink Sheet)