Recon: China Eases Drug Import Rules; GSK Licenses Two Hep B Candidates From Ionis

• FDA gives fast track status to AstraZeneca's diabetes drug Farxiga (Reuters) (Press)
• Pharma Cash Rolls Into Congress To Defend An Embattled Industry (KHN)
• Watch: In never-before-seen video, Purdue’s Richard Sackler defends OxyContin marketing (STAT)
• An FDA report reveals the agency believed Novartis data problems were resolved months ago (STAT)
• Bristol-Myers opens up the Phase 0 pathway in testing its new cancer therapies, following in Celgene’s footsteps (Endpoints)
• J&J liable for $572 million in Oklahoma opioid epidemic trial; shares rise (Reuters) (NYTimes)
• Why Was Johnson & Johnson the Only Opioid Maker on Trial in Oklahoma? (NYTimes)

• Canadian officials say ‘all options’ on the table in responding to Trump importation plan (STAT)
• GSK licenses Ionis' experimental hep B treatments in up to $262M deal (Endpoints) (Fierce)
• China Eases Rules on Cheap Drug Imports to Fight Chronic Diseases (NYTimes)
• How big pharma is targeting India's booming opioid market (The Guardian)
• HMRC targets GSK contractors in UK tax crackdown (Financial Times)
• NICE to work with GW Pharma after Epidiolex rejection (PhamaTimes)
• Biotechs fight fears of ‘antibiotic apocalypse (Financial Times)
• Brazil ‘Internationalizes’ GMP Regulatory Framework (Pink Sheet-$)
• German Oncology Biosimilars Take Over Three-Fifths Of The Available Market (Generics Bulletin-$)
• EC Approves Alexion’s Soliris for Neuromyelitis Optica Spectrum Disorder (Press)
• Japan’s GHIT ramps up fight against neglected diseases (Financial Times)
• Debate over vaccination strategies dogs Ebola efforts in Congo (Financial Times)

• Transplanting islet cells can fix brittle diabetes. Why isn’t it available in the U.S.? (STAT)
• The Opioid Crisis (Bloomberg)
• Developing cancer drugs from African plants (Nature)
• FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels (Focus)
• FDA Calls for Men to be Enrolled in Breast Cancer Trials (Focus)
• FDA's OPDP Warns Metuchen Pharmaceuticals Over Misleading DTC Ads (Focus)
• Top FDA exec Edward Cox jumps ship and joins Regeneron as new regulatory VP (Endpoints)
• Biopharma jobs boom in Massachusetts, though challenges still exist (BioPharmaDive)
• Gene editing: even Crispr (Financial Times)
• The Medicines Company Trumpets New Inclisiran Cholesterol Lowering Results, But Big Questions Remain (Forbes)
• How Oracle Is Using Cloud Tech To Find Cancer Cures (Forbes)
• Adaptimmune pledges $312M for Noile-Immune's T cell boosting tech in drive to deliver on TCR promise (Endpoints) (Fierce)
• Boehringer pharma chief heads for the exit amid a top-level reshuffling (Fierce) (Endpoints)
• Franchise killer: Are Regeneron and Sanofi about to get handed their walking papers on PCSK9? (Endpoints) (Fierce)
• Strides buys soft gel capsule facility in U.S. (Fierce)
• For sale: Boston Children’s team touts a new CRISPR delivery system for triple-negative breast cancer — plus — after testing it in mice and cells (Endpoints)
• Playing the game of biotech chutes and ladders: The lure of raw science (Fierce)
• Pharma's shift away from TV to digital is inevitable, report says (Fierce)
• Heart Failure Drug Development Might Need A Good Lawyer After US FDA Guidance (Pink Sheet-$)
• CRISPR slows the growth of triple-negative breast cancer in mice (Fierce)

• Santhera's Duchenne effort gets a boost on positive PhIIa for alternative steroid vamorolone — though there's a lot left to prove (Endpoints)
• Sigilon Therapeutics Receives Orphan Drug Designation for SIG-001 for the Treatment of Hemophilia A (Press)
• Viela Bio Announces U.S. FDA Accepts for Review Inebilizumab Biologics License Application for Neuromyelitis Optica Spectrum Disorder (Press)
• InDex's topical ulcerative colitis drug hits goal in phase 2b (Fierce) (Press)
• LEO Pharma Files IND Application to FDA for a Clinical Study of JW1601/LP0190 in the US (Press)
• Worldwide Clinical Trials Works with Orphazyme to Complete Recruitment of Phase 3 Trial in ALS (Press)
• Antibe Therapeutics Provides Update on Phase 2B Dose-Ranging, Efficacy Study for ATB-346 (Press)

• Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn (Focus)
• Survey From CDRH Officials Finds Informed Consent Process Needs Improving (Focus)
• STAAR Surgical Announces FDA IDE Clinical Study Approval (Press)
• AtriCure wins expanded indications for AtriClip LAA (MassDevice)
• FDA approves Alcon’s AcrySof IQ PanOptix trifocal IOL (MassDevice) (Press)

• DEA to expand marijuana research after years of delay (Reuters)
• The Most Expensive Medicare Patients Aren't Who You Think (Forbes)
• Mysterious Vaping Lung Injuries May Have Flown Under Regulatory Radar (KHN)
• Insurer that denied cancer treatment asks for dismissal of Boston woman’s lawsuit (Boston Globe)
• Preemption After Albrecht – Retiring “Most Favorable” Factual Review (Drug & Device Law)
• Deference to Agency Deference (FDA Law Blog)

• FDA Advisory Committee Calendar

• Watch Out For Early Effects Of SPC Waiver, UK Firms Told (Pink Sheet-$)
• Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028) (MHRA)

• Drug Risk Information of Ongoing Evaluation (PMDA)
• Asia Regulatory Roundup: China Changes Stance on Fake Drugs and Online Sales in Legal Update (Focus)

• Pharma company accountant held for sharing its data with rival firm (Economic Times)
• Shadow On Novartis' Ceritinib In India After Patent Revoked (Scrip-$)
• AFDLH writes to DCGI against state FDA for exempting exporters from submitting stability data (Pharmabiz)
• NPPA fixes ceiling prices of 2 products under DPCO 2013 dated Aug 23 (Pharmabiz)

• TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework - an overview, 12 June 2019 (TGA)

• 42nd Expert Committee on Drug Dependence (ECDD) 21 to 25 October 2019, WHO Headquarters, Geneva Switzerland  (WHO)
• Venezuelan migrants to get regional vaccination cards under 10-nation pact (Reuters)