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Regulatory Focus™ > News Articles > 2019 > 8 > Recon: China Eases Drug Import Rules; GSK Licenses Two Hep B Candidates From Ionis

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

Posted 27 August 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Other International
  • 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)
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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