Recon: FDA to get less funding in Senate budget bill for FY 2023 compared to House version; EU funders fail to measure clinical trial transparency
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 (The Pink Sheet) (Senate)
- US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas (The Pink Sheet)
- FDA greenlights Marius; oral hypogonadism pill; VBL Therapeutics makes cuts to its workforce (Endpoints)
- Biden Names Monkeypox Coordinator as States Declare Emergencies (Bloomberg) (Washington Post)
- Gottlieb predicts monkeypox will become public health failure (The Hill)
- A chaotic sprint to lower insulin prices and AIDS activists go after Biden on monkeypox (STAT)
- Paxlovid rebound happens, though why and to whom are still a mystery (STAT)
- California governor declares monkeypox emergency (Reuters) (Bloomberg)
- Thousands of lives depend on a transplant network in need of ‘vast restructuring’ (Washington Post)
In Focus: International
- Major European research funders often fail to set policies or monitor progress on clinical trial transparency (STAT) (JAMA)
- EU signs joint procurement deal with HIPRA for COVID vaccines (Reuters)
- Amid Expected Enhertu Entry, Chinese Domestic ADC Developers Race To Market (Scrip)
- Inside the super-secure Swiss lab trying to stop the next pandemic (Reuters)
Pharma & Biotech
- After delay, CSL’s $11.7B deal for Vifor poised to close next week (Fierce)
- Analyst ahead of H1 report: Strong momentum looks set to continue for Novo Nordisk (Medwatch)
- Genentech-AC Immune’s Alzheimer’s drug failed, but what have they learned from crenezumab? (Fierce) (Endpoints)
- AstraZeneca Ends Phase 3 Study on Immunotherapy in Head and Neck Cancer (FDAnews)
- ObsEva Scraps Plans for Uterine Fibroid Candidate (FDAnews)
- Axcella misses primary endpoint in long COVID trial but plots path to market based on fatigue scores (Fierce)
- Amid Expected Enhertu Entry, Chinese Domestic ADC Developers Race To Market (Scrip)
- With $122M, Startup IDRx Intends to Stop Cancer Mutations in their Tracks (Biospace)
- Less than two weeks after failure-induced stock shock, VBL Therapeutics lays off staff (Fierce)
- New biotech from Alexis Borisy will test Merck KGaA, Blueprint cancer drug combo in bid to fulfill Gleevec promise (Endpoints)
- Under pressure from advocates, ViiV strikes a deal to make its long-acting HIV injectable more accessible (Endpoints)
- French biotech armed with Series A looks to build out manufacturing facility for plant-based protein tech (Endpoints)
Medtech
- US FDA Provides Monkeypox Update, Including Testing Protocols (MedTech Insight)
- BioMérieux Gets 510(k) Clearance for Vidas Neprocheck Assay (FDAnews)
- FDA Provides Update on Covidien’s Recall of Its Palindrome and Mahurkar Hemodialysis Catheters (FDAnews)
- Bose abandons hearing aid plans, hands off direct-to-consumer tech to Lexie Hearing (Fierce)
- Cognito’s light-and-sound therapy slows brain tissue atrophy in Alzheimer’s study (Fierce)
- South Korea develops nanotech tattoo as health monitoring device (Reuters)
Government, Regulatory & Legal
- Boston Scientific pays $85M to settle long-running patent dispute with Nevro (MedTech Dive) (Law360)
- AbbVie Beats Antitrust Challenge to Humira Patent Settlements (Bloomberg)
- AstraZeneca Nexium Suits Should Overcome Preemption Challenge (Bloomberg)
- West Virginia cities reach $400 mln opioid distributor settlement (Reuters) (Bloomberg)
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.
