Recon: Danaher to purchase Masimo for $9.9B; EU authorizes higher dose of Novo’s Wegovy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
FDA rejects Disc Medicine's rare disease drug despite granting it a commissioner voucher (Endpoints)
Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod (Reuters )
Act For ALS Boosted Drug Access, But Rollout Faced Initial Hurdles, GAO Says (Pink Sheet)
Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda & Plausible Mechanism Draft Guidance On Its Way (FDA Law Blog)
CDC Left Leaderless Again After Acting Director Departs HHS (BioSpace) (Reuters)
In Focus: International
As China’s drug industry races ahead, its GLP-1 race is accelerating too (STAT)
Lilly targets India as global export hub amid booming Mounjaro sales (Reuters)
EU approves higher dose of Novo Nordisk's Wegovy (Reuters)
Dr Reddy’s says Wegovy copycat to be priced competitively, with 50–60% discounts feasible (Reuters)
Obesity Drug Boom Buoys Ireland’s Pharma Production for Export (Bloomberg)
Elevidys Becomes Japan’s Highest-Priced Drug Nine Months After Approval (Pink Sheet)
Time for Innovative Medicines Fund 2.0 in England: Industry and Patients Want Change (Pink Sheet)
Pharma & Biotech
Ocular’s experimental eye drug beats low dose of Regeneron’s Eylea in late-stage trial (STAT)
Compass says its psilocybin drug helped patients with severe depression in two trials (STAT)
Boehringer Ingelheim stops work on inhaled cystic fibrosis gene therapy (Endpoints)
Roche heads to regulators with new autoimmune win for Gazyva (Fierce Pharma)
Lilly's rare cancer drug Retevmo looks to broaden reach with adjuvant trial win (Fierce Pharma)
Medtech
Danaher to buy Masimo in $9.9 billion deal in diagnostics push (Reuters)
Medtronic completes first Hugo case in the US (MedTech Dive)
Medline Recalls Beds After Reports Of Injuries and Deaths Due To Fire, Entrapment (MedTech Insight)
NASA’s Former AI Chief Omar Hatamleh: AGI Is Closer Than We Think, Then Everything Will Change (MedTech Insight)
Food & Nutrition
A Life-Saving Vitamin for Babies Is Getting Swept Up in Vaccine Backlash (Bloomberg)
Familiar faces: Why food and beverage companies are bringing back former CEOs (Food Dive)
Government, Regulatory & Legal
In a financial pinch, major health insurers are turning to AI for help (STAT)
When IV opioids are in short supply at the hospital, who gets pain relief? (STAT)
AMA CEO: Deepfake doctors are a threat to public health (STAT)
Bayer proposes $10.25 billion plan for all Roundup cancer cases (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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.