Recon: Novartis Wins FDA Approval for Eye Drug; New ICER Report on Net Drug Price Hikes

ReconRecon | 08 October 2019 |  By 

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-$)
  • Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer Price (FDA Law Blog)
  • FDA leaders worry agency will lose out on talent in gene therapy, cancer fields (BioPharmaDive)
  • Acorda Rebuffed by U.S. Supreme Court Over Ampyra Patents (Bloomberg)
  • Exclusive: Top drug lobbyist to depart next year (Politico) (BIO)
  • Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth (Stat-$)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • '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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • With $65M, Cygnal Tunes In to Nerve Signals for Drug-Making Clues (Xconomy)
  • Multiplex Rainbow Technology Offers New View of the Brain (NIH)
  • Trio Health and American Rheumatology Network Create New National Rheumatology Data Registry (Press)
  • New Data Insights from the Phase 3 Teprotumumab Trial (OPTIC) to be Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Scientific Symposium (Press)
  • AVROBIO Announces First Patient Dosed in Phase 1/2 Trial of Gene Therapy for Cystinosis (Press)
Medical Devices
  • SSRN Reading List . . . or Device Regulation: What Role for Tort Law? (Objective Intent)
  • National Emission Standards for Hazardous Air Pollutants: Generic Maximum Achievable Control Technology Standards Residual Risk and Technology Review for Ethylene Production (EPA)
  • An App That Can Catch Early Signs Of Eye Disease In A Flash (NPR)
  • Biodesix Names Dr. James Jett Chief Medical Officer (Press)
  • Could robots be psychology’s new lab rats? (Science)
  • FUJIFILM Irvine Scientific Receives CE Mark Approval for Multiple ART Media (Press)
US: Assorted & Government
  • Remarks by Dr. Sharpless to the 2019 Biopharma Congress (FDA)
  • Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss (Focus)
  • Gottlieb Says IPI Coming; Grogan Says Administration Making Tweaks (InsideHealthPolicy-$)
  • 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-$)
Upcoming Meetings & Events Europe
  • 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)
  • Chasing AbbVie, Gilead files for approval of filgotinib in Japan (Fierce) (Press)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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