Recon: FDA approves generic lenacapavir intended for lower income countries; EMA to review Lundbeck's Deanxit for reported serious side effects
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries (AP News)
- US FDA approves Inovio's treatment for rare throat disease; shares surge (Reuters) (FDA)
- FDA approves Sun Pharma’s Ilumya for psoriatic arthritis, as clinic-administered IL-23 inhibitor (The Pharma Letter)
- FDA provides clarity to support cell and gene therapy development and quality (FDA)
- US health department to remove broad black box warning from three estrogen patch products (Reuters) (Pink Sheet)
- Adcomm supports FDA verdict on Sydnexis’ myopia drug, finds trial and literature issues (Pink Sheet)
- FDA to review uniQure's Huntington's gene therapy, decision due on May 2027 (Reuters)
- ACIP seeks new members, suggesting resurgence in 2027 (Pink Sheet)
- FDA pushes back PFUFA date for Agios’ sickle cell disease sNDA (The Pharma Letter)
- FDA, CMS scramble to avoid regulatory logjam as more states look to test AI in clinical settings (STAT)
In Focus: International
- EMA to review Lundbeck's depression, anxiety drug Deanxit after serious side effects reported (Reuters)
- MHRA backs expanded use of Vertex’ Casgevy (The Pharma Letter)
- MHRA conditionally approves Ultragenyx’s Dojolvi for rare fatty acid oxidation disorders (The Pharma Letter)
- Indian pharma: OPPI seeks policy reforms, Goyal stresses R&D (The Pharma Letter)
- EU opens smoother import route for Singapore-made APIs (Pink Sheet)
- UK’s rare disease framework risks ‘going no further’ without NICE alignment (Pink Sheet)
- FAST-EU’s speedier trial reviews may be creating a conditional-approval problem (Pink Sheet)
- Japan's Omron Healthcare taps India manufacturing to reduce reliance on Vietnam (Reuters)
- South Africa's Aspen Pharmacare to sell women's health product in Europe to Ennogen (Reuters)
- Bavarian Nordic gets four-year contract for mpox and smallpox vaccine from UK government (Reuters)
Pharma & Biotech
- AstraZeneca follows GSK with $1.5B annual savings push (Endpoints) (BioSpace)
- Fresenius signs biosimilars pipeline agreement with WuXi Biologics (Reuters) (Fierce Pharma)
- Aspen Neuroscience lands $141M IPO, while Bambusa secures $169M (Endpoints) (The Pharma Letter)
- CinRx, Sam Waksal's Graviton team up on ROCK2 for PAH, other cardio conditions (Endpoints)
- China's InventisBio delivers competitive TYK2 data in phase 3 psoriasis win (Fierce Biotech)
- Lower dose of Tiziana's MS drug reduces neuroinflammation, while higher dose struggles (Fierce Biotech) (Reuters)
- Teva ends trial of one of its original line-up of innovative meds over futility (Fierce Biotech) (Reuters)
- Pelthos Therapeutics to merge with Castle Creek Biosciences (The Pharma Letter)
- Jazz's $820M Actio buyout gives rise to Setara, armed with $90M series A (Fierce Biotech)
- UniQure snags May Day decision date for Huntington’s gene therapy after arduous year (BioSpace)
Medtech
- France recalls more condoms over manufacturing defects (Reuters)
- Lilly boosts Alzheimer’s pipeline with blood and speech diagnostics (Medtech Insight)
- Resmed’s new strategy takes shape as sleep sales boost Q1 2027 (Medtech Insight)
- Dexcom plays down PBM contract loss, readies ‘Dexcom Direct’ to steer patients to medical benefit (Medtech Insight)
- Illumina lifts 2026 outlook as NovaSeq X placements rise but instrument revenue slips (Medtech Insight)
Food & Nutrition
- FDA warns rice noodle maker about sanitation failures (Food Safety News)
- Indonesian free meals agency pledges urgent action to curb food poisoning (Reuters)
Government & Legal
- How Congress can fix expert advisory committees (STAT)
- Federal judge rejects new Medicaid ‘frailty’ definition for work requirements (STAT)
- US court lifts ruling requiring Idaho to allow some abortions to protect women's health (Reuters)
- Medicaid work requirements go live in 2 months. Many states won't be ready. (Politico)
- The four biggest ways the midterms could change health policy, according to policymakers, lobbyists, and experts (STAT)
- In dueling health messages, Democrats focus on cost and Republicans on fraud (New York Times)
- The trust-busters going after CVS are Republicans (Politico)
- Why a MAHA mom who loves RFK Jr. is backing Democrats who don’t (Politico)
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.
