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June 27, 2023
by Michael Mezher

Recon: Lilly’s experimental ‘triple G’ drug achieves 24% weight loss in Phase 2; Merck, Ridgeback withdraw EU COVID drug application

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Analysis: Weight loss drug candidates multiply, spurring hopes of better outcomes, lower costs (Reuters)
  • Obesity drug Wegovy's popularity has US employers rethinking insurance coverage (Reuters)
  • Lilly experimental 'triple G' obesity drug leads to 24.2% weight loss in trial (Reuters)
  • With Wegovy and Ozempic’s success, can device makers keep up in the race to treat obesity? (STAT)
  • First U.S. malaria cases diagnosed in decades in Florida and Texas (Reuters)
  • Illumina starts job cuts, plans office exit to rein in costs (Reuters)
  • GSK's gonorrhoea vaccine receives FDA's 'fast-track' designation (Reuters)
  • Grail faces uphill battle to get Medicare to cover its cancer screening test (STAT)
  • The DEA Relaxed Online Prescribing Rules During Covid. Now It Wants to Rein Them In. (KFF)
  • Rep. Pallone pushes House Republicans to address drug shortages in PAHPA reauthorization (Endpoints)
In Focus: International
  • Merck, Ridgeback withdraw COVID drug application in EU (Reuters)
  • More evidence needed on Lilly's weight loss drug, UK watchdog says (Reuters)
  • EMA Fees: Parliamentary Committee Insists On Full Transparency & Sufficient Funding (Pink Sheet)
  • Egyptian Agency Becomes First ICH Member From Africa, Get Rights To USP (Pink Sheet)
  • EU Clinical Trials System Should Be Free Of Major Bugs Within Three Months (Pink Sheet)
  • UK's flagging clinical trial sector faces fresh challenge as National Cancer Research Institute set to close (Fierce) (Endpoints)
  • Development of a guideline on the quality aspects of mRNA vaccines (EMA)
Pharma & Biotech
  • FDA’s McMullen: No Bigger Waste Than Drug Shortages Due To Data Integrity (Pink Sheet)
  • Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative (FDA)
  • FDA approves first of two UCB myasthenia gravis drugs, following Alexion and argenx’s lead (Endpoitns)
  • Ipsen’s Palovarotene Ultra-Rare Bone Disorder Drug Faces Hurdles At US FDA Adcomm (Pink Sheet) (Endpoints)
  • FibroGen plans new round of cost cuts after latest study setback (BioPharmaDive)
  • Brookings’ Drug Shortages Remedies Target Both Hospitals And Manufacturers (Pink Sheet)
  • Blackstone injects $140M cash into Sutro Biopharma for Vaxcyte royalties (Fierce)
  • Reckitt creates 'air sanitizing spray' effective against coronavirus (Reuters)
  • Sanofi's $1.1B eczema drug hits midphase goal, spurring talk of phase 3 and new indications (Fierce)
  • After data breadcrumbs, Takeda shows elimination of deadly blood clot attacks for rare disease drug (Fierce)
  • J&J touts PhII data in rare blood disorder as it plots a pivotal study (Endpoints)
  • Aldeyra says its candidate won in chronic cough PhII, setting stage for bout with Merck, GSK (Endpoints)
  • Xentria and Meitheal ink licensing deal for rare lung disease treatment in North America (Endpoints)
Medtech
  • Fresenius Medical Care shares drop on U.S. dialysis payment adjustment (Reuters)
  • FDA Prepares To Regulate LDTs, One Way Or The Other (MedtechDive)
  • Restor3d inks Conformis buyout, adding hip and knee implants to portfolio (MedtechDive)
  • How Manufacturers Of Innovative Devices For Stroke Patients Could Benefit From EU Funding (MedtechDive)
Government, Regulatory & Legal
  • J&J's $8.9 billion talc settlement faces US bankruptcy test (Reuters)
  • A Comprehensive Overview Of PTAB Trends For Biologics (Law360)
  • AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert (Fierce)
  • Lilly reaches $2.4 million settlement with EEOC over age discrimination lawsuit (STAT)
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.
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