Recon: FDA approves AZ’s breast cancer drug over negative adcomm vote; Novartis sees setbacks for drugs targeting cholesterol, myotonic dystrophy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves AstraZeneca’s oral SERD for breast cancer despite negative adcomm vote (Endpoints) (BioSpace)
- Ionis wins FDA clearance for Alexander disease drug, company's first solo neurology approval (Endpoints) (Ionis)
- FDA tightening foreign clinical trial enforcement amid phase 1 re-shoring campaign (Pink Sheet)
- FDA hiring binge reversing losses, but only slightly (Pink Sheet)
- FDA and SEC compare notes: What the new MOU means for FDA-regulated public companies (FDA Law Blog)
- The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains (STAT)
- A breakthrough pancreatic cancer drug won approval. They still struggle to access it (STAT)
In Focus: International
- Industry warns EMA’s role in filing dates could erode EU market protection incentive (Pink Sheet)
- Cepheid’s Ebola test becomes fourth WHO emergency diagnostic (Medtech Insight)
- Novo Nordisk says semaglutide cut obesity rates in young children in trial (Reuters)
- England’s new QoL measurement triggers drug access warning from industry (Pink Sheet)
- EMA tests mechanism for better-timed, better-prepared drug filings (Pink Sheet)
- EMA to test speedier scientific advice for focused drug development questions (Pink Sheet)
- EMA clarifies how to submit ePI as countdown begins to digital transition (Pink Sheet)
- EMA tries again on NAMs data sharing after ‘safe harbor’ mechanism falls flat (Pink Sheet)
- WHO says staff shortage, funding challenges hamper Congo Ebola response (Reuters)
- Claret says its latest fund will have larger focus on European life sciences (Endpoints)
- Italy's Menarini gets into obesity with European rights to GLP-1 from China's Gan & Lee (Endpoints)
Pharma & Biotech
- Novartis’ experimental cardiovascular drug fails a pivotal study (STAT) (Reuters)
- Neuromuscular drug from Novartis fails in key study, adding to pressure on company (STAT) (Endpoints)
- Novo Nordisk cans two more trials of IL-6 heart drug for futility (Endpoints) (STAT)
- Inhibrx opens door to cancer vaccine combo for its OX40 agonist (Endpoints) (STAT)
- Daiichi unit American Regent recalls 3 epinephrine batches on particulate, leakage concerns (Fierce Pharma)
- Pharvaris' genetic disorder drug meets main goal in late-stage trial (Reuters)
- Diabetes cell therapy biotechs Sernova and Seraxis to merge (Endpoints)
- Gilead opens research center as $32 billion US build-out continues (PharmaLetter)
- AstraZeneca's drug combo helps lung cancer patients live longer in late-stage study (Reuters)
- AstraZeneca’s experimental COPD treatment posts strong results in late-stage studies (STAT)
- Roivant reports phase 2 win for lung disease drug that it got from Bayer (Endpoints) (Reuters)
- Bristol Myers' blood cancer cell therapy succeeds in mid-stage trial (Endpoints) (Reuters)
Medtech
- FDA backs PFAS in medical devices as Europe moves to ban them and suppliers offer alternatives (Medtech Insight)
- Abbott wins FDA approval for dual-energy ablation catheter (Medtech Dive)
- Vara receives CE mark for first autonomous breast cancer screening (MedTech Dive)
- Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries (Medtech Dive) (Medtech Insight)
- Carvolix will accelerate AI/robotic cardio and stroke plans with €30m debt funding (Medtech Insight)
- Appeals court upholds device right to repair as DMCA renewal looms (Medtech Insight)
- iRhythm to buy VitalConnect, plugging 30-day MCT gap and broadening its cardiac monitoring platform (Medtech Insight)
- From ISH downclassification to RAPID exclusion: FDA maps the diagnostics landscape (Medtech Insight)
Food & Nutrition
- Cyclospora outbreak followed years of declining FDA foreign inspections (AP News)
- Bubs Australia gets permanent FDA nod for infant formula sales in US, shares jump (Reuters)
- EU opens comments on cereulide limit proposals for infant formula (Food Safety News) (Food Safety Magazine)
- Raids, shutdowns, warning labels - India's unprecedented food safety push (Reuters)
Government & Legal
- Gov. Shapiro gets validation: A Pennsylvanian did die of measles (Politico) (Reuters)
- Kennedy hires COVID vaccine skeptic to look at dubious claims of military deaths (New York Times)
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.
