Recon: FDA grants Concerta generic withdrawal hearing; Ivonescimab wins first-line NSCLC nod in China
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA grants hearing on Lannett generic Concerta withdrawal (Pink Sheet)
- FDA tweaks PDUFA meeting structure: Type D expanded, INTERACT limited (Pink Sheet)
- Former CBER compliance office director Melissa Mendoza lands in private sector (Pink Sheet)
- QMSR is here: FDA’s first QMSR warning letters (FDA Law Blog)
- When the label lags the science: Using 505(o)(4) to compel labeling changes (FDA Law Blog)
- Lawsuit against Bristol Myers over delayed cancer drug is revived (Reuters)
In Focus: International
- Akeso's ivonescimab wins landmark first-line NSCLC nod in China (Fierce Pharma)
- UK regulator endorses safety of childhood vaccination (Reuters)
- Novartis defeats UK court bid to invalidate blockbuster drug Entresto patent (Reuters)
- Novo CEO says obesity market won't be winner-take-all battle with Lilly (Reuters)
- EU’s AI act climbdown raises stakes for MDR revisions (Medtech Insight)
- Drugmakers curb Swiss reimbursement applications over US pricing concerns (Reuters)
- Canada sets clinical trial transparency expectations ahead of mandatory rules (Pink Sheet)
- Canada moves to cut pharmacovigilance inspection burden (Pink Sheet)
- Industry groups urge India to enact standalone Medical Devices Act, say 30-plus fixes ignored (Medtech Insight)
- Seeking faster oversight, notified bodies request full access to EU medtech database (Medtech Insight)
- Talks on launch of clinical trial of Ebola vaccine in DRC advance, WHO says (STAT)
Pharma & Biotech
- Fresenius pulls one batch of Actemra biosim over glass particle concerns (Fierce Pharma)
- Neurocrine Biosciences rare disease drug possibly tied to safety issues, experts say (STAT) (Endpoints)
- Eli Lilly files first lawsuits over retatrutide 'black market' (Endpoints) (Reuters)
- Definium's LSD drug clears bar in first of two phase 3 anxiety disorder trials (Endpoints) (STAT)
- Did Exelixis use a 'trivial' modification to its cash cow to product-hop past a patent cliff? These researchers think so (Endpoints)
- Taiho, Cullinan's lung cancer drug passes phase 3 test, lining up Rybrevant contest (Endpoints)
- Biotech company co-founded by top autoimmune researcher lays out plans with antibody therapies (STAT) (Endpoints)
- PTC Therapeutics, Lilly to buy up bits of Sangamo in bankruptcy auction (Endpoints) (BioSpace)
- Zealand sells milestone, royalty rights to rare blood cancer asset for up to $100M (BioSpace)
Medtech
- Breakthrough device sponsors to lose key payment bridge as FDA, CMS demands climb (Medtech Insight)
- Former SpineFrontier CFO sentenced to four months in surgeon kickback scheme (Medtech Insight)
- Four serious injuries linked to class I recall of Hamilton Medical ventilator circuit sets (Medtech Insight)
- What Medicare incentives for AI-based devices mean for tech companies and hospitals (STAT)
- J&J bets on outpatient ablation boom with ACCESS GPO electrophysiology deal (Medtech Insight)
- Medtronic veteran departs for CEO role at heart valve startup (MedTech Dive)
- Alcon’s new-product wave carries Q2 as it walks away from accommodating IOL bet (Medtech Insight)
- Five barriers blocking Asia-Pacific’s medtech ascent and the playbooks to overcome them (Medtech Insight)
Food & Nutrition
- Acting FDA chief urges confidence in lettuce as agency updates produce safety guidance (New York Times) (Reuters)
- Whole Foods recalls items containing jalapenos on potential salmonella contamination (Reuters)
Government & Legal
- Vaccine makers throw cold water on Trump’s push to split MMR vaccines (Endpoints) (STAT)
- Providers notch No Surprises Act legal win that could boost their pay (STAT)
- US appeals court voids formula used to avert surprise medical bills (Reuters)
- AbbVie, Novartis and Bristol Myers file 340B lawsuits in Illinois (Endpoints)
- Trump administration’s new ‘treatment first’ addiction toolkit emphasizes faith, abstinence (STAT)
- Medicaid will stop paying for some gender-affirming care for transgender minors (STAT) (Reuters)
- Snapchat creates ad format to support pharma disclosure needs (Fierce Pharma)
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.
