Regulatory Focus™ > News Articles > Regulatory Recon: China Slams GSK With $492M Fine, Deportation for Execs (19 September 2014)

Regulatory Recon: China Slams GSK With $492M Fine, Deportation for Execs (19 September 2014)

Posted 19 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: China Slams GSK With $492M Fine, Deportation for Execs (19 September 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA hands Eli Lilly a big win, OKs dulaglutide for diabetes (Fierce) (FDA) (SCRIP-$) (Forbes) (MedPage Today) (Press) (PMLive) (Pharma Times) (BioCentury)
  • FDA advisers shoot down Clarus' pitch for a new low-T drug (Fierce) (Tarius) (WSJ-$) (Medscape) (Pink Sheet-$) (BioCentury) (Press)
  • Vioxx, Ten Years Later: It's Continuing Effects on the Regulatory System (Pharm Journal)
  • Critics demand stronger warnings for potent antibiotics (USA Today)
  • Compounding Group to FDA: Proposed Rule Should be Delayed While Compounding AdComm is Constituted (FDA)
  • On the Regulation of Redirecting Ads (RegulatoryRx)
  • US FDA Advisory Committee Hears Updates of Research Programs About Monoclonal Antibodies and Therapeutic Proteins (Tarius)
  • Takeda Hid Actos Bladder Cancer Risks, Philly Jury Hears (Law 360-$)
  • "Accelerating Medicines Partnership" and other Collaborations to Speed Discovery of New Therapies (Policy and Medicine)
  • 20 Years of Improving Women’s Health: 1994 – 2014 (FDA)
  • Hearings on new business models for antibiotics (TIE) (E&C)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Flexion discusses sterility issue (BioCentury)
  • Lilly's Cyramza shows survival benefit in gastro cancers (Pharma Times)
  • Merck's weekly DPP-IV on par with daily Januvia: study (MM&M) (Fierce)
  • Navidea Receives Orphan Drug Designation from FDA for Use of Lymphoseek in Head and Neck Cancers (Press)
  • Salix Announces FDA User Fee Goal Date of February 28, 2015 for XIFAXAN® 550mg sNDA for Treatment of Irritable Bowel Syndrome with Diarrhea (Press)

US: Pharmaceuticals and Biotechnology: General

  • After Obamacare, two-thirds of insured women now get their birth control pills free (Vox)

US: Medical Devices

  • NxStage Dialysis Needle Technology Gets FDA Nod (Gray Sheet-$) (Mass Device) (Press)
  • Intuitive Surgical expands into transoral surgery with new FDA win (Mass Device) (Press)
  • FDA Clears Siemens’ SOMATOM Scope CT System (Mass Device)
  • EOS imaging receives FDA clearance for new software dedicated to sagittal balance and posture analysis (MNT)

US: Dietary Supplements

  • FTC Releases Draft Consent Agreement Against Supplement Company for Bad Ad Practices (FTC) (FTC)

US: Assorted And Government

  • FDA Weekly Enforcement Report (FDA)
  • House passes repackaged 'jobs bills' containing regulatory provisions (The Hill)
  • Lawmakers exit Washington to campaign (The Hill)

Upcoming Meetings

Ebola Outbreak

  • Why the Ebola vaccine is still years away (Vox)
  • MHRA praised as the first volunteer receives new Ebola vaccine in UK clinical trial (MHRA)
  • Eight bodies found after attack on Guinea Ebola education team  (Reuters)

Europe

  • EMA rejects claims of undue industry influence on data disclosure policy (SCRIP-$)
  • Europe okays Novo Nordisk diabetes combo Xultophy (Pharma Times) (Press) (BioCentury) (Fierce)
  • European Commission Grants Marketing Authorization for Gilead’s Zydelig (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma (Press)
  • ABPI backs NICE call to review NHS adoption of new drugs (Pharma Times)
  • Secure Italian military lab to grow medical marijuana (Reuters)

India

  • NPPA caps prices of 43 drug formulation packs (India Times) (SCRIP-$) (India Times) (India Times) (Reuters)
  • Health ministry to revise Schedule M-III for medical devices to make it harmonious with international standards (PharmaBiz)
  • Pharmexcil to step up interaction between DCGI, DGFT and stakeholders to help exports (PharmaBiz)
  • NPPA asks drug makers to register for online database (India Times)
  • India's Drug War Is Good News (Bloomberg View)

China

Japan

  • Aricept Approved In Japan As Treatment For Dementia With Lewy Bodies (Press)

Canada

  • ''Feeble’ Health Canada can't block dodgy drug imports (The Star)

Australia

  • Marketing functional foods in Australia - how to navigate the rules on health and therapeutic claims (Food Processing)

Other International

  • ASEAN Supplement Harmonization 90% Complete (NPI)
  • Human error seen in measles vaccination deaths in Syria: WHO (Reuters) (Forbes)
  • Country At A Glance: Chile (Arazy Group)

Clinical Trials

  • A New Era in Risk-Based Monitoring (Reuters)
  • Two New RBM Papers from TransCelerate (Polaris)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #403 – 19 September 2014

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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