Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Drugmakers' shares stabilize after Zantac litigation slump (Reuters)
- In a momentous vote for Pelosi, House sends drug pricing reforms to President Biden’s desk (STAT)
- Analysis: US move to negotiate drug prices a rare defeat for Big Pharma (Reuters)
- Newly-launched US drugs head toward record-high prices in 2022 (Reuters)
- Emergent receives FDA warning letter over quality control issues (Reuters)
- Novavax seeks U.S. authorization for COVID vaccine booster (Reuters)
- Brainstorm to seek FDA approval for ALS stem-cell treatment, despite agency objections (STAT)
- Hospital and Drugmaker Move to Build Vast Database of New Yorkers’ DNA (NYTimes)
- UK first to approve Omicron COVID shot with Moderna nod (Reuters) (FT) (NYTimes) (MHRA)
- The UK won't purchase AstraZeneca's Evusheld, citing 'insufficient data' (Fierce)
- U.S. and Switzerland working on facilitating pharma trade, U.S. ambassador says (Reuters)
- Abbott to add 1,000 jobs in $450 million Irish investment (Reuters)
- Novartis fails again to reuse anti-inflammatory drug to treat lung cancer (Reuters)
- AstraZeneca says data confirms Enhertu benefit in breast cancer patients (Reuters)
- Serum Institute of India's Poonawalla expects Omicron-specific vaccine in 6 months -NDTV (Reuters)
- WHO plans to rename monkeypox over stigmatization concerns (NBC)
- Korea Regulatory Streamlining Plans Eye Innovation, Commercialization Support (Pink Sheet)
- US FDA Training Up Inspectorate To Oversee Quality Of Novel Manufacturing Technologies (Pink Sheet)
- Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward (Pink Sheet)
- Ensuring a future for gene therapy for rare diseases (Nature)
- An antibiotics player axes staff in wake of PhIII fail; Horizon to fund antibody development, with option to buy (Endpoints)
- Atai prunes pipeline, drops out of partnerships as it takes on $175M loan and focuses on looming data readouts (Endpoints)
- Ideaya stock slashed after GSK punts an option (Endpoints)
- Pyxis taking scalpel to preclinical pipeline, stops development on half — for now (Endpoints)
- Clene claims its PhII MS trial, half its intended size, cleared the primary goal. But can the biotech afford PhIII? (Endpoints)
- You can add a colorful Australian mining tycoon to the list of billionaires betting on biotech (Endpoints)
- Carlyle finds its first big biotech bet after teaming with Abingworth (Endpoints)
- A treatment for monkeypox was approved under the FDA’s ‘Animal Rule.’ Here’s what that means (STAT)
- As fungal infections grow resistant to medication, desperate patients try drug after drug (NBC)
- How science is getting closer to a world without animal testing (FT)
- Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential (MedtechInsight)
- Illumina sets aside $453M to prep for potential EU fines over Grail acquisition (Fierce)
- Pear Therapeutics trims workforce, forecast as state contracts move slower than expected (MedtechDive)
- J&J, other orthopedics companies faced unequal pandemic recovery in second quarter (MedtechDive)
- Boston Scientific bulks up blood-blocking portfolio with Obsidio acquisition (Fierce)
- BD’s recall of emergency vascular access devices labeled Class I event by FDA (MedtechDive)
- Paving the way for Merck's buyout, Seagen loses arbitration dispute with Daiichi Sankyo over ADC tech (Endpoints) (BioPharmaDive)
- Pharma Exec Admits Lying To FDA About Weight-Loss Drug (Law360)
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