Recon: Novartis Wins FDA Approval for Eye Drug; New ICER Report on Net Drug Price Hikes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Novartis gets FDA boost in crowded eye drug market (Reuters) (PMLive) (Press)
- ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence (ICER) (Reuters) (Stat-$)
- Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer Price (FDA Law Blog)
- FDA leaders worry agency will lose out on talent in gene therapy, cancer fields (BioPharmaDive)
- Acorda Rebuffed by U.S. Supreme Court Over Ampyra Patents (Bloomberg)
- Exclusive: Top drug lobbyist to depart next year (Politico) (BIO)
- Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth (Stat-$)
- World report on vision (WHO)
- Crisis in the supply of medicines (BMJ)
- Sanofi employees start 96-hour work abstention (Business Standard)
- EMA Staff Losses Tick Up as Workload Increases (Focus)
- European Medicines Agency's Priority Medicines (PRIME) scheme at 2 years: An evaluation of clinical studies supporting eligible drugs (Study)
- Zantac – MHRA drug alert issued as GlaxoSmithKline recalls all unexpired stock (MHRA)
- Novo, Uni of Birmingham team up against fatty liver disease (Pharma Times)
- Gilead's CAR-T therapy Yescarta now available via NHS Scotland for two forms of B-cell lymphoma (Pharmafile)
- Chinese infectious disease biotech Ascletis nabs Novartis exec as CSO (Fierce)
- J&J completes €300m Irish expansion, adding 200 jobs (Biopharma-Reporter)
- 'Project Orbis' Oncology Pilot Eventually Will Target 'Major Impact' Applications (Pink Sheet-$)
- AstraZeneca enlists artificial intelligence for sales rep coaching (FiercePharma)
- Merck taps 4D pharma for bacterial vaccine R&D project (Fierce)
- Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls (Pink Sheet-$)
- New Cambridge biotech Korro aims to develop a reversible form of gene editing (Boston Business Journal)
- A cancer company has misled investors repeatedly about its drug. It’s time for some truth-telling (Stat-$)
- Kate Pickert Writes About Her Ordeal With Cancer In 'Radical' (NPR)
- AMAG Pharmaceuticals Announces Settlement Agreement with Caligan Partners LP (Press)
- GenSight Biologics Appoints Magali Taiel as Chief Medical Officer (Press)
- Merck Issues 2018/2019 Corporate Responsibility Report (Press)
- With $65M, Cygnal Tunes In to Nerve Signals for Drug-Making Clues (Xconomy)
- Multiplex Rainbow Technology Offers New View of the Brain (NIH)
- Trio Health and American Rheumatology Network Create New National Rheumatology Data Registry (Press)
- New Data Insights from the Phase 3 Teprotumumab Trial (OPTIC) to be Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Scientific Symposium (Press)
- AVROBIO Announces First Patient Dosed in Phase 1/2 Trial of Gene Therapy for Cystinosis (Press)
- SSRN Reading List . . . or Device Regulation: What Role for Tort Law? (Objective Intent)
- National Emission Standards for Hazardous Air Pollutants: Generic Maximum Achievable Control Technology Standards Residual Risk and Technology Review for Ethylene Production (EPA)
- An App That Can Catch Early Signs Of Eye Disease In A Flash (NPR)
- Biodesix Names Dr. James Jett Chief Medical Officer (Press)
- Could robots be psychology’s new lab rats? (Science)
- FUJIFILM Irvine Scientific Receives CE Mark Approval for Multiple ART Media (Press)
- Remarks by Dr. Sharpless to the 2019 Biopharma Congress (FDA)
- Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss (Focus)
- Gottlieb Says IPI Coming; Grogan Says Administration Making Tweaks (InsideHealthPolicy-$)
- Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product (FDA)
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)
- Warning letter for Family Fertility Center (FDA)
- With a new lobbying group and a day at the White House, synthetic biology looks for footing in Washington (Stat-$)
- EU tells British PM Johnson to stop playing 'stupid' Brexit blame game (Reuters)
- Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033) (MHRA)
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.