Recon: AbbVie’s schizophrenia drug from $9B buyout falters in 2 studies; FDA lifts hold on Novavax flu-COVID vaccine trials
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Schizophrenia drug AbbVie picked up in $9 billion acquisition fails in key trials (STAT)
- Risk of aspiration during surgery added to GLP-1 drug labels (STAT)
- What can Trump and RFK Jr. actually do on health care? (STAT)
- What the Trump administration could mean for the health care industry, from hospitals to pharma (STAT)
- Biotech analyst Brian Skorney and CEO Daphne Zohar weigh in on election results (STAT)
- FDA lifts hold on Novavax vaccines after adverse event reclassified as ALS (Endpoints)
- Updated: FDA approves Autolus’ CAR-T cell therapy for aggressive blood cancer (Endpoints)
- Chinese study recommends region-specific diets, amid rising obesity risks (Reuters)
- WHO to convene emergency meeting on mpox on Nov. 22 (Reuters)
- UK MHRA: ‘At Least Half’ Of Novel Drug Filings To Take National Assessment Route (Pink Sheet)
- UK Toolkit To Accelerate Research Set-Up Across England, NI, Scotland And Wales (Pink Sheet)
- Japan Recommends Approval Of Brukinza, Balversa (Pink Sheet)
- Sarepta discontinues next-generation Duchenne drugs (STAT)
- Yorvipath’s approval showcases biopharma’s interest in rare endocrine disorder (Endpoints)
- Assertio denies activist investor's claims of fraud in open letter (Endpoints)
- Thermo Fisher consolidates viral vector work in Massachusetts, cuts 160 workers (Endpoints)
- Danish company pays $145M upfront to license nasal spray alternative to EpiPen (Endpoints)
- Cell therapy startup's IPO plans thrown in limbo amid legal spat with investor Alcon (Endpoints)
- Children’s Hospital Los Angeles tests generative AI to translate discharge notes into Spanish (STAT)
- These 6 companies are using AI to streamline clinical trials for pharma (STAT)
- Advamed CEO congratulates Trump, stresses need for public policy support (MedTech Dive)
- Baxter to restart second IV fluid production line at hurricane-damaged site (MedTech Dive)
- Tandem, Insulet tout Type 2 expectations as tech attracts new users (MedTech Dive)
- Exact Sciences’ forecast cut shocks analysts (MedTech Dive)
- J&J MedTech Wins FDA Approval For Varipulse Pulsed Field Ablation Platform To Treat Afib (MedTech Insight)
- Social media misinformation is scaring women about birth control (STAT)
- A new Trump administration will further loosen already-lax rules on supplements (STAT)
- Cigna says it will not pursue a merger with Humana (Endpoints)
- US minority veterans face unequal access to Ozempic and Wegovy, study finds (Reuters)
- Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development (FDA Law Blog)
- RSV Vaccines: ACIP Recommendations For Adults Younger Than Age 60 Await More Data (Pink Sheet)
- 2025 Part D Landscape Files Reveal Plans Are ‘Managing Their Risk More Carefully’ (Pink Sheet)
- Informed Consent Should Address Standard Of Care Risks, US FDA’s Califf Says (Pink Sheet)
- How the healthcare industry is reacting to a second Trump term (MedTech Dive)
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