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)
- 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)
- 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)
- 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)
- 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)
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