Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns

| 15 August 2022 | By Michael Mezher 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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