Recon: Vaping as good as drug for smoking cessation; FTC scrubbing Orange Book of device patents
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Why health care spending keeps climbing (STAT)
- Vaping is just as good as Chantix at helping people quit cigarettes, new study finds (STAT)
- Under pressure to thwart pharma patent abuse, the PTO proposes a new rule. But will it fly? (STAT)
- FDA places partial hold on BioNTech-MediLink ADC after multiple deaths (Endpoints)
- Teva in talks to settle US lawsuit alleging MS drug kickbacks (Reuters)
- J&J to seek appeal of $150M verdict in long-spanning HIV meds off-label marketing case (Fierce Pharma)
- AI and Adverse Events: Tech Not Ready For Prime Time For Case Safety Reports, US FDA Says (Pink Sheet)
- Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents (FDA Law Blog)
- EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports (Pink Sheet)
- First Drug Treatment For Myopia Among 14 New EU Filings (Pink Sheet)
- EU HTA Regulation: Guidance Released On Joint Clinical Assessment Scoping & Reporting (Pink Sheet)
- UK Early Access Scheme Treatments More Likely To Get Faster NICE Stamp Of Approval (Pink Sheet)
- Eli Lilly’s Alzheimer’s candidate, Bob Langer’s new startup, and other biotech news you need to know (STAT)
- AstraZeneca backs up Calquence's potential in mantle cell lymphoma with detailed data (Fierce Pharma)
- Aerovate’s stock craters after PAH drug fails Phase 2 study (Endpoints)
- Argenx drops post-Covid syndrome program; Mirum picks a dose for bile duct disease drug (Endpoints)
- Marinus reports mixed Phase 3 results on IV seizure drug (Endpoints)
- Deerfield backs $81M round for biotech developing antifungal therapy with less toxicity (Endpoints)
- Oncologists turn to blood test for circulating tumor DNA, but questions remain on how to use the data (STAT)
- PFA devices are changing AFib treatment. The next wave could grow the market further (MedTech Dive)
- Merit Medical recalls plastic syringes made by Jiangsu Shenli (MedTech Dive)
- Agilent to cut 3% of employees as sluggish lab equipment market persists (MedTech Dive)
- Teleflex catheter kit recall linked to 31 injuries, 3 deaths (MedTech Dive)
- Medtech group updates EtO standard for first time in 25 years (MedTech Dive)
Government, Regulatory & Legal
- Bird flu snapshot: A critic of the U.S. response speaks out, and USDA tries to ‘corner the virus’ (STAT)
- Why a big California employer ditched Elevance for some of its health plans (STAT)
- Novo Nordisk CEO to testify in US Senate hearing on high cost of Ozempic, Wegovy (Reuters)
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.
