Recon: FDA Oks J&J’s Talvey for blood cancer; Novo agrees to buy obesity drugmaker Inversago for $1B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves Johnson & Johnson's blood cancer therapy (Reuters) (Endpoints)
- Obesity drug data could boost companies' case for US coverage (Reuters)
- US hospital pharmacists ration drugs as shortages persist – survey (Reuters)
- ‘Underwhelming’: NIH trials fail to test meaningful long Covid treatments — after 2.5 years and $1 billion (STAT)
- Genentech weighs slow-walking ovarian cancer therapy to make more money under drug pricing reform (STAT)
- Tainted Medication Fears Spur US Defense Department to Seek Outside Testing (Bloomberg)
- Decentralized Trials: Stakeholders Press FDA On Design Flexibility, Role Of HCPs, Harmonization (Pink Sheet)
- New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination (Pink Sheet)
- BioNTech and Twitter warned by PR body for trying to duck COVID-19 vaccine debate (Fierce Pharma)
- Bumps On The Path To EU Harmonized Standards Path As Stakeholders Demand Speedier Progress (MedTech Insight)
- Pakistan Acts To Harmonize Disclosure Of Medtech Payments To Doctors (MedTech Insight)
- Coronavirus Notebook: WHO Issues New Recommendations On Access To COVID-19 Products Amid Spread Of New EG.5 Variant (Pink Sheet)
- Regulators Still To Get To Grips With Neurodegenerative Outcome Measures (Pink Sheet)
- How Do Japan’s Clinical Trial eConsent Rules Compare With The EU And US? (Pink Sheet)
- Rare Diseases: European Market Access ‘Better Organized’ Than US, Says Rhythm (Pink Sheet)
- Novo eyes other health benefits from weight-loss drug Wegovy after major trial (Reuters)
- Novo Nordisk CEO sees US supply curbs on weight-loss drug Wegovy into 2024 (Reuters) (STAT)
- Novo Nordisk to acquire obesity drug developer Inversago (Reuters) (BioSpace)
- Pharma budget tightening trickles down to Doximity (STAT)
- Anavex, maker of rare disease drug, keeps shifting the goalposts in its clinical trials (STAT)
- DNA-sequencing giant Illumina slashes 2023 revenue projections (STAT)
- Regeneron dials up in gene therapy with Decibel deal (Pharmaphorum) (BioSpace)
- Exclusive: AstraZeneca’s outgoing R&D chief Mene Pangalos reflects on a 14-year R&D turnaround and the industry's future (Endpoints)
- Galera Therapeutics to cut 70% of staff in wake of rejection for radiotherapy complication treatment (Endpoints)
- Emergent commits to layoffs and C-suite trimmings, no longer focusing on CDMO activity (Endpoints)
- Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges (BioSpace)
- Mirati CEO Steps Down After Going Toe-to-Toe with Amgen in KRAS (BioSpace)
- Bluebird Pins Hopes on Zynteglo Uptake, FDA Verdict Amid Cash Constraints (BioSpace)
- Regeneron's high-dose Eylea shows staying power as company awaits FDA decision (Fierce Pharma)
- Dyslipidemia space to 'undergo a massive shake-up,' but pharmas must price new drugs carefully: report (Fierce Pharma)
- Despite mounting failures, analysts see NASH market as holding 'enormous untapped potential' (Fierce Pharma)
- Elevidys Clinical Development: Confidence In Surrogate Endpoint A Longstanding Concern For FDA Reviewers (Pink Sheet)
- Boston Scientific receives FDA approval for cryoablation system (MedTech Dive)
- Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts (MedTech Dive)
- Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations (MedTech Dive)
- Elon Musk’s brain implant company raises $280M to fund clinical trials (MedTech Dive)
- Guardant, Illumina agree to end litigation, extend commercial partnership (MedTech Dive)
- July Warning Letter Prompts Pause In Dialysis Accessory Distribution (MedTech Insight)
- CDC director overhauls leadership of center that oversaw response to Covid-19 (STAT)
- Companies Advised To ‘Re-Think’ SPC & Regulatory Strategies For ‘Loose’ Combination Products (Pink Sheet)
- Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant (Fierce Pharma)
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