Recon: New FDA oncology chief vows continued innovation in OCE; FDA approves drugs for two rare genetic diseases
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind OCE legacy (Fierce Pharma)
- Scholar Rock wins FDA approval for first drug to target SMA muscle loss (STAT)
- FDA approves Pharming’s Joenja for children (The Pharma Letter)
- FDA extends review of Exelixis' colorectal cancer drug candidate (Endpoints) (Reuters)
- Woman dies of complications from measles in western Pennsylvania (Reuters)
- Patients urge FDA to address financial, logistical barriers in chronic wound clinical trials (Pink Sheet)
- OS in oncology: FDA message to plan for interim analyses resonating (Pink Sheet)
- Opioid benefit-risk should include harm of under-treating pain, patients say (Pink Sheet)
- Insomnia drug sponsors support DEA bid to loosen controls, but want more flexibility (Pink Sheet)
- PDUFA reauthorization offers a chance at clinical trial reforms. Will the US take it? (PharmaVoice)
In Focus: International
- Industry backs EU shift toward value-based procurement but warns on localization (Pink Sheet)
- Pharma wins a battle over the cost of wastewater treatment in Europe (STAT)
- Industry wary as EMA walks the fine line between better dossiers and filing control (Pink Sheet)
- Singapore to expand HSA’s remit to simplify industry engagement (Pink Sheet)
- Broad political consensus on new pharma policy for Sweden (The Pharma Letter)
- Industry seeks clear rules for resolving filing date disputes with EMA (Pink Sheet)
- Australia’s 5% discount rate is costing patients access to drugs - industry calls for fix (Pink Sheet)
- German industry assesses reimbursement and health reform challenges as Bundestag resumes (Medtech Insight)
- GSK makes ‘difficult decision’ to shutter German flu vaccine manufacturing site (Fierce Pharma) (Reuters)
- Ebola infections top 7,000 in Democratic Republic of Congo, government data show (Reuters)
Pharma & Biotech
- Seeking a fresh start, Novo drops the 'Nordisk' (Endpoints) (STAT)
- GE HealthCare in talks over possible $1 billion deal for Sofie Biosciences (Financial Times) (Reuters)
- Electra Therapeutics targets $977.6 million valuation in US IPO (Bloomberg) (Reuters)
- Akeso details survival win for its PD-1xVEGF drug versus Keytruda (Endpoints) (Fierce Pharma)
- Definium says its LSD drug notched another phase 3 win in anxiety disorder (Endpoints) (STAT)
- BioNTech says lung cancer drug candidate prolonged lives in trial (Reuters) (Bloomberg)
- AstraZeneca’s next-gen SERD disappoints in untreated advanced breast cancer (Endpoints) (STAT)
- Sanofi divests older medicines as new CEO pushes for innovation (Bloomberg)
- Merck, Gilead’s failed Trodelvy lung cancer trial shows better China results (Fierce Pharma)
- Cullinan, Taiho showcase 6-month survival benefit in phase 3 trial for advanced lung cancer (Fierce Biotech)
Medtech
- CDRH moves to close rare disease device gap with new initiative and device list (Medtech Insight)
- Flow Neuroscience launches at-home, FDA-approved brain stimulation device for depression in US (Medtech Insight)
- FDA approval in hand, Implantica prepares to launch mechanical GERD fix in US (Medtech Insight)
- J&J orthopedics unit draws Apollo interest in potential $20 billion deal (Bloomberg) (Reuters)
- Diagnostics firms expect German health minister to deliver on market access and ‘dialog’ agenda (Medtech Insight)
- Bridge to Life’s $110 million bet on making hypothermic perfusion - and viability testing - standard of care (Medtech Insight)
- Plaque plus physiology: Elucid’s $55 million Series D funds a two-front coronary AI push (Medtech Insight)
- An AI tool aims to catch harder-to-detect heart attacks in EKGs (STAT)
Food & Nutrition
- US officials declare an end to record-setting cyclospora outbreak, but its origin is still unknown (STAT) (Reuters)
- FDA warns two food importers about failures involving peppers, candy and other foods (Food Safety News)
- Canada posts results of food safety surveillance across range of commodities for microbial, chemical contaminants (Food Safety Magazine)
- India court orders regulator to provide timeline for food warning labels (Reuters)
Government & Legal
- Confirmatory evidence for all? FDA’s approval of Lytenava for wet AMD shows how non-rare diseases can use confirmatory evidence and that ‘failed’ studies can provide confirmatory evidence (FDA Law Blog)
- Right before midterms, Trump dangles $500 refunds for select ACA enrollees (STAT) (New York Times)
- Arizona accuses L'Oreal of concealing cancer risks linked to hair relaxers (Reuters)
- Pharma marshalling legal challenges of Medicare negotiation fixed combo policy (Pink Sheet)
- Trump’s secretive pharma deals may undermine ‘most-favored nation’ pricing, an analysis suggests (STAT)
- Restoring public trust in science doesn’t have a simple solution. That’s OK (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.
