Recon: Will labs sue US FDA over LDT proposed rule? EU Rapporteur slams commission’s proposals
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
In Focus: International
- 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)
Pharma & Biotech
- 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)
Medtech
- 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)
Government, Regulatory & Legal
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
