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

• 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)

• 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)

• 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• BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.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)

• 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)

• Edwards launches US pivotal Centera self-expanding TAVR study (MassDevice)
• Wright Medical closes $435m Cartiva buy (MassDevice)
• Concept Medical raises $60m for sirolimus-coated balloon IDE trial (Drug Delivery)
• Switchback Medical debuts in Twin Cities metro (Medical Design & Outsourcing)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Designing an Economic Bioethics (Harvard Bill of Health)