Regulatory Focus™ > News Articles > Regulatory Recon: GSK Accused of Bribery in Romania as Gov't Probes 11 Cancer Drugmakers (31 July 20

Regulatory Recon: GSK Accused of Bribery in Romania as Gov't Probes 11 Cancer Drugmakers (31 July 2015)

Posted 31 July 2015 | By Michael Mezher 

Regulatory Recon: GSK Accused of Bribery in Romania as Gov't Probes 11 Cancer Drugmakers (31 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Why Pharma Must Change Its Model (Forbes)
  • Why is Everyone So Surprised about FDA Side Effect Reporting Delays? (Adverse Events)
  • FDA approvals for the first 6 months of 2015 (Nature-$, Free Table)
  • Drone transport 'does not affect blood samples' (MNT)
  • Ten Steps to Comply with FDA UDI Requirements (RegistrarCorp)
  • What’s New in Health Disparities? (FDA Voice)
  • Senate Bill Would Protect Banks Serving Marijuana Businesses (FDA Law Blog)
  • Plaintiffs Allowed to Make a Case Out of Thin Air in Prozac Case (FDA Law Blog)
  • Prosecution of Off-Label Speech In A Post-Caronia World (Law360-$)

In Focus: International

  • GSK faces new corruption allegations, this time in Romania (Reuters) (FiercePharma)
  • Romania Investigates 11 Drugmakers in Separate Bribery Probe (Reuters)
  • Bribery and corruption in the pharma industry: what the law says (SCRIP-$)
  • New Drug Approvals in ICH Countries 2005 – 2014 (Life Sciences Connect)
  • Bacteriophage therapies re-enter clinical trials (Nature-$)
  • EU Publishes New List of Standards for Medical Device Directives (MassDevice)
  • NHS England launches investigation into drug company payments (Pharmaceutical Journal)
  • DoP to study factors affecting competitiveness of Indian medical devices in domestic market (PharmaBiz)
  • Indian pharma views latest norms on analytical & validation methods for drugs & biologics crucial for global audits (PharmaBiz)
  • China Ups Penalties for Quality Violators under Tougher Regulation (Gold Sheet-$)
  • Japan Commits to Comparability Protocols as ICH Q12 Takes Shape (Gold Sheet-$)
  • WHO's Chan says initial results from Ebola vaccine trial 'promising' (Reuters) (Merck)
  • Approval of biosimilar insulins: regulations across the globe (GaBI)
  • Key drug regulatory changes take effect in Russia (SCRIP-$) (Pink Sheet-$)
  • Is Asia's IP landscape in for big changes under TPP? (FiercePharmaAsia) (Nikkei)

US: Pharmaceuticals and Biotechnology

  • Why Pharma Must Change Its Model (Forbes)
  • Bribery and corruption in the pharma industry: what the law says (SCRIP-$)
  • Why is Everyone So Surprised about FDA Side Effect Reporting Delays? (Adverse Events)
  • FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix and antiplatelet Brilinta (FDA) (FDA)
  • FDA proposes monitoring quality at drugmakers to avert shortages (ModernHealthcare) (Focus)
  • HCTZ Bottles Recalled After Discovery of Blood Thinner Tablet (MPR)
  • FDA Dings Pfizer China Facility Over Sample Retesting, Other cGMP Deviations (FDANews)
  • FDA Modifies REMS for Tanzeum, Trulicity (MPR)

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

  • Galapagos reports additional Phase IIb filgotinib data in RA (BioCentury)
  • Ascendis announces Phase II results for ACP-001 (BioCentury)
  • Worth The Money? Paying To Ensure A Representative Cohort In The Precision Medicine Initiative (HealthAffairsBlog)
  • FDA Approves Bayer's Finacea Foam, 15% for Treatment of Inflammatory Papules and Pustules of Mild to Moderate Rosacea (Press)
  • Amphetamine XR-ODT NDA Resubmitted for ADHD Treatment (MPR)
  • Dactinomycin Nanoparticle Formulation Receives Orphan Drug Designation (MPR)
  • Mundipharma EDO Announces FDA INDA of its First Anti-Cancer Compound (Press)
  • Positive Phase 3 Results for Plecanatide in Chronic Idiopathic Constipation (MPR)
  • FDA Approves Deltoid Injection Site for Abilify Maintena for extended-release injectable suspension in the Treatment of Schizophrenia (Press)
  • Isis antisense drug lowers triglycerides; Phase III ongoing (SCRIP-$)
  • Synergy scores second Phase III success for plecanatide (SCRIP-$)
  • No expansion for Astellas' Cresemba (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • FDA approvals for the first 6 months of 2015 (Nature-$, Free Table)
  • ACR position statement on biosimilars addresses naming and substitution (GaBI)
  • FDA ReleasesVICH Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products Guidance (FDA)
  • Drone transport 'does not affect blood samples' (MNT)

US: Medical Devices

  • Ten Steps to Comply with FDA UDI Requirements (RegistrarCorp)
  • 2-pound DNA-reader could help fight Ebola, TB, HIV (Fortune)
  • At Internet of Things hearing, industry groups petition Congress for light regulatory touch (MobiHealthNews)
  • FDA clears device to protect caregivers from hazardous drug exposure (FierceMedicalDevices)
  • Blood test predicts prognosis for traumatic brain injuries (MNT)
  • Colonoscopies of the future: Adjustable-focus endoscope helps to reduce discomfort (MNT)
  • New 3-D human skin models could replace animal testing to assess dermal sensitivity to medical device (MNT)

US: Assorted and Government

  • What’s New in Health Disparities? (FDA Voice)
  • Senate Bill Would Protect Banks Serving Marijuana Businesses (FDA Law Blog)
  • Plaintiffs Allowed To Make a Case Out of Thin Air in Prozac Case (FDA Law Blog)
  • Prosecution Of Off-Label Speech In A Post-Caronia World (Law360-$)
  • No New Trial For Drug Buyers In Nexium Pay-For-Delay Suit (Law360-$)
  • Medical Device Manufacturer NuVasive Inc. to Pay $13.5 Million to Settle False Claims Act Allegations (DoJ)
  • Senate Uses Valeant Pharma, Burger King, AB InBev To Expose Unequal Corporate Taxation In U.S. (Forbes)
  • Gaming the US tax system: 'Wolf packs,' other strategies (SCRIP-$)
  • Territorial systems, 'patent boxes' urged for US tax reform (SCRIP-$)
  • Biotech-specific Subject Matter Eligibility Materials Delayed (Patent Docs) (Federal Register)
  • Actavis hit with lawsuit over generic version of weight-loss drug (GaBI)

Upcoming Meetings and Events                                                            

Europe

  • EU Publishes New List of Standards for Medical Device Directives (MassDevice)
  • GSK faces new corruption allegations, this time in Romania (Reuters) (FiercePharma)
  • Romania Investigates 11 Drugmakers in Separate Bribery Probe (Reuters)
  • NHS England launches investigation into drug company payments (Pharmaceutical Journal)
  • UK public don’t understand meaning of antibiotic resistance (OnMedica)
  • EMA opens consultation on revision of biosimilar G-CSF guideline (GaBI)
  • Biosimilars penetration in Europe varies widely (GaBI)
  • Echo's cannabis API delivery formulation could aid low solubility drugs (In-Pharma Technologist)
  • Roche's Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer (Press)

India

  • Strides Arcolab gets USFDA nod for Benzonatate capsules (Economic Times)
  • DoP to study factors affecting competitiveness of Indian medical devices in domestic market (PharmaBiz)
  • Indian pharma views latest norms on analytical & validation methods for drugs & biologics crucial for global audits (PharmaBiz)
  • India drugs watchdog to look at feasibility of online drug sales (FiercePharmaAsia)

China

  • China Ups Penalties for Quality Violators under Tougher Regulation (Gold Sheet-$)

Japan

  • BIO joins coalition to caution against further restructuring of Japan’s Pharmaceutical Pricing (BioSpectrum)
  • Japan Commits to Comparability Protocols as ICH Q12 Takes Shape (Gold Sheet-$)

Canada

  • Health Minister Announces Regulatory Amendments to Help Control Prescription Drug Abuse in Canada (Press)
  • Health Product InfoWatch July 2015 (Health Canada)              
  • Submissions Under Review (Health Canada)

Australia

  • GMiA becomes Generic and Biosimilar Medicines Association (Biosimilar News)

Ebola Outbreak

  • Vaccine success holds hope for end to deadly scourge of Ebola (Reuters)
  • WHO's Chan says initial results from Ebola vaccine trial 'promising' (Reuters) (Merck)

Other International

  • Bacteriophage therapies re-enter clinical trials (Nature-$)
  • New Drug Approvals in ICH Countries 2005 – 2014 (Life Sciences Connect)
  • Approval of biosimilar insulins: regulations across the globe (GaBI)
  • Key drug regulatory changes take effect in Russia (SCRIP-$) (Pink Sheet-$)
  • Is Asia's IP landscape in for big changes under TPP? (FiercePharmaAsia) (Nikkei)

General Health and Interesting Articles

  • What will genomics look like in a decade? (MedCityNews) (PLOS)
  • CDC says too few U.S. teens getting HPV vaccine (CBS News)
  • The European Space Agency sent Kombucha into space for science and stuff (Washington Post)
  • Medication may reduce injury risk for kids with ADHD (Reuters)

Regulatory Reconnaissance #608– 31 July 2015

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 @Michael_Mezher 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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