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Recon: China Approves 17 Cancer Drugs for National Health Insurance Coverage

Posted 10 October 2018 | By Michael Mezher 

Recon: China Approves 17 Cancer Drugs for National Health Insurance Coverage

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Early blood cancer trial is shuttered, possibly dimming hopes for promising therapy (STAT)
  • FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote (Fierce) (FDA)
  • FDA staff says AcelRx opioid painkiller is not better than rivals (Reuters)
  • No More Secrets: Congress Bans Pharmacist ‘Gag Orders’ On Drug Prices (KHN)
  • Perrigo appoints new CEO, reshuffling leadership for 3rd time since 2016 (BioPharmaDive) (WSJ)
  • That New Apple Watch EKG Feature? There Are More Downs Than Ups (NYTimes)
  • Short-term rule fight likely to fizzle (Politico)
  • Trump Administration Seeks Public Comments On Marijuana Reclassification (Forbes) (Federal Register)
  • Walking the walk, Alnylam appoints former FDA head Margaret Hamburg to the board (Endpoints)
  • In New York, Gotham Starts Up With $54M for RNA-Modifying Drugs (Xconomy) (Endpoints) (Fierce)
  • Novartis builds its case for a new sickle cell drug, eyeing a delayed FDA filing in ’19 (Endpoints) (PharmaTimes)
  • The Death of the IPO (The Atlantic)
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In Focus: International
  • China approves 17 anti-cancer drugs for medical insurance coverage (Reuters) (Fierce) (Gov.CN)
  • Russia to allow imported drugs that have not undergone clinical trials in the country (PharmaLetter-$)
  • A look ahead to key trial readouts at ESMO (PMLive)
  • NICE recommends first new X-linked hypophosphataemia therapy in over 30 years (Pharmafile) (PharmaTimes)
  • Update on EMA’s Brexit preparedness (EMA)
  • Scotland Launches New ‘Ultra-Orphan’ Assessment Pathway (Pink Sheet-$)
  • WHO voices concern over British immigration policies after researchers refused entry (Pharmafile)
  • Stada, eyeing OTC expansion, circles Bristol-Myers’ French Upsa business: report (Fierce)
  • Ebola response tightens in eastern Congo as seven new cases confirmed: health ministry (Reuters)
Pharmaceuticals & Biotechnology
  • One of the world’s largest drug makers is paying docs again — and patients are the worse off (STAT)
  • As it moves out of the lab, CRISPR brings tough questions into the clinic (STAT)
  • At Hal Barron’s R&D group at GSK, consensus is out, leaders are in and watch out for an ‘intense drive’ to spur the late-stage pipeline (Endpoints)
  • Opinion: Cure for cancer would become more likely if FDA streamlined the drug approval process (The Hill)
  • Petition Approval Letter from FDA CDER to Baxter Healthcare Corp (FDA)
  • BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. (BIO)
  • Eyeing NASH, Glympse Raises $22M to Test Disease Detection Nanotech (Xconomy)
  • Rare disease startup Therachon to absorb GLyPharma and its SBS candidate (Fierce)
  • CAR-T therapies face logistical bottleneck as market set to see major growth (MedCity)
  • Novartis Launches Biome Health Tech Initiative (BioCentury)
  • Docs in Urban Settings Favor Brand-Name Drugs (Medpage)
  • Neurocrine, Jnana team up to discover CNS drugs (Fierce)
  • We Haven’t Ruled Out Drug Price Increases, Says Regeneron’s Schleifer (SCRIP-$)
  • Sackler-owned Mundipharma acquires biosimilar firm Cinfa Biotech (Pharmafile)
  • Formal Dispute Resolution: A Different Perspective on Wins and Losses (FDA Law Blog)
  • Standardization Of Drug Compendia That Support Off-Label Use Reimbursement Of Cancer Drugs (Forbes)
  • Clinical trial transparency: ‘There is no one answer to what must be disclosed’ (Outsourcing Pharma)
  • Report: Corporate venture capital is catalyzing groundbreaking biomedical innovation in the United States (PhRMA)
  • Want An RMAT Designation? Please Include At Least Some Data, US FDA Tells Sponsors (Pink Sheet-$)
  • Innovation challenges are all the rage with pharma, and they're likely here to stay: study (Fierce)
  • Ziopharm cuts Precigen ties, narrowing its R&D focus (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression Over Five Years in Relapsing and Primary Progressive Multiple Sclerosis (Press)
  • Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray for Treatment-Resistant Depression (Press)
  • New analysis estimates the positive impact of empagliflozin on prolonging life expectancy in adults with type 2 diabetes and established cardiovascular disease (Press)
  • Epizyme to Present Updated Data on Tazemetostat from Full Phase 2 Study Cohort in Epithelioid Sarcoma at ESMO (Press)
  • New Analyses from Pivotal Phase 3 Trials of Oral Ozanimod to Be Presented at ECTRIMS 2018 (Press)
  • Antibe Therapeutics Receives Approval to Initiate Part One of Phase 2B Dose-Ranging, Efficacy Study for ATB-346 (Press)
Medical Devices US: Assorted & Government
  • For U.S. patients, access to medical records often difficult and costly (Reuters)
  • Boston Scientific Merger Trial Fast-Tracked In Chancery (Law360-$) (MassDevice)
  • AdvaMed Backs Wright Medical in Hip Liability Case (MDDI)
  • Gilead, Indian Generic Co. Drop Truvada Infringement Suit (Law360-$)
  • 450 Tribes Demand A 'Seat At The Table' In Opioid MDL (Law360-$)
  • Conn. Jury Hands Boehringer 3rd Straight Pradaxa Trial Win (Law360-$)
  • What About Erie? (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Vertex Extends Portfolio Pricing and Reimbursement Approach To Denmark (Pink Sheet-$)
  • How To Deal With A Dawn Raid By Competition Authorities (Pink Sheet-$)
  • Collaboration to enhance gene therapy logistics in Japan’s growing market (BioPharmaReporter)
  • Indian pharma market posts lower growth of 7.5% in September 2018 to Rs. 11,324 crore (PharmaBiz)
  • Notice: Regulatory Enrolment Process (REP) Pilot for Division 1 & Division 8 (human drugs) regulatory activities (Health Canada)
  • Australian Government response to the Senate Community Affairs References Committee report (TGA)
General Health & Other Interesting Articles 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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