Regulatory Focus™ > News Articles > Regulatory Recon: EMA's Clinical Data Transparency Measures Face Critical Vote Today (2 October 2014

Regulatory Recon: EMA's Clinical Data Transparency Measures Face Critical Vote Today (2 October 2014)

Posted 02 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: EMA's Clinical Data Transparency Measures Face Critical Vote Today (2 October 2014)

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

In Focus: US

  • FDA's Sentinel Program Now Officially Online, Out of Test Phase (Pharm Journal)
  • FDA Gives Innovation, Harmonization Added Attention In Final Priorities Report (Pink Sheet-$)
  • FDA Annual Summary Report on Antimicrobials Sold or Distributed in 2012 for Use in Food-Producing Animals (FDA)
  • FDA Releases Final GDUFA Technology and Informatics Plan (FDA)
  • "Reminder-like" Promotions and Black Box Drugs (RegulatoryRx)
  • An Active Fall Anticipated For mHealth Regulatory Policymaking (Gray Sheet-$)
  • FDA Panel Rejects Sonablate 450 HIFU Device For Prostate Cancer (Gray Sheet-$)
  • HHS to Release Report on Informed Consent and 45 CFR Part 46 (DHHS)

In Focus: International

  • European Medicines Agency votes on clinical trial transparency today (All Trials) (EMA)
  • WHO Provides Extensive Situation Breakdown on Ebola, Treatments (WHO)
  • Paying for High-Priced Drugs: Comparing Global Strategies from U.S., UK, and Scotland (Context Matters)
  • Landmark UK patent law change will boost clinical research (PharmaTimes)
  • Lundbeck's alcohol consumption pill gets NHS green light (PharmaTimes)
  • India, US to Form Working Group on IP Issues (India Times)
  • GlaxoSmithKline, NewLink working to bring Ebola vaccines online: WHO (Reuters) (SCRIP-$)
  • Hedge Funds Listen In on Patient Chats for Pharma Bets (Bloomberg)

US: Pharmaceuticals and Biotechnology

  • FDA's Sentinel Program Now Officially Online, Out of Test Phase (Pharm Journal)
  • FDA Gives Innovation, Harmonization Added Attention In Final Priorities Report (Pink Sheet-$)
  • FDA Annual Summary Report on Antimicrobials Sold or Distributed in 2012 for Use in Food-Producing Animals (FDA)
  • FDA Releases Final GDUFA Technology and Informatics Plan (FDA)
  • Takeda Shared Actos Cancer Data, Ex-FDA Official Testifies (Law 360-$)
  • "Reminder-like" Promotions and Black Box Drugs (RegulatoryRx)
  • Upsher Smith, Strides Arcolab Seeking ANDA Pathway for Generic Namenda (FDA) (FDA)
  • Drug side effects study published, debunks previously accepted limitation in the use of FEARS data for monitoring drug safety (MNT)
  • Expert Details Benefits of Social Media Use for Drug Development (FDA News-$)
  • Social Media Monitoring: The Next Frontier In Corp. Integrity Agreements? (Pink Sheet-$)
  • Injectable Zantac in Shortage Due to API Disruptions (FDA)
  • California Governor Vetoes antibiotic farm bill, seeks new legislation (SCPR)
  • ‘Sham’ Programs? Novartis Must Face a Kickback Lawsuit Filed by the Feds (Pharmalot)

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

  • Regeneron, Sanofi Say Sinusitis Drug Met Goals (AP) (PMLive) (Press)
  • ARIAD’s AP26113 Receives FDA Breakthrough Therapy Designation For ALK+ Non-Small Cell Lung Cancer Resistant to Crizotinib (Press)
  • Erytech reports positive Phase III results from Graspa study in acute lymphoblastic leukemia (PharmaLetter-$) (Press)
  • Takeda presents Phase III data for Entyvio in UC and Crohn’s Disease (Pharma Letter-$)
  • Intarcia’s Phase III diabetes data shows sustained blood sugar control (Pharma Letter-$) (Fierce)
  • Esperion's ETC-1002 succeeds in Phase IIb, but Zetia combo could be key (SCRIP-$) (BioCentury) (Fierce)
  • FDA Grants Fast Track Designation to NKT Therapeutics' NKTT120 for the Treatment of Sickle Cell Disease (Press)
  • Lilly to Discontinue Development of Tabalumab Based on Efficacy Results in Phase 3 Lupus Studies (Press) (Bloomberg)

US: Medical Devices

  • An Active Fall Anticipated For mHealth Regulatory Policymaking (Gray Sheet-$)
  • FDA Panel Rejects Sonablate 450 HIFU Device For Prostate Cancer (Gray Sheet-$)
  • FDA Issues Draft LDT Guidance Documents; Provides 120-Day Comment Period and will Host October Public Meeting (FDA Law Blog)
  • Covidien Unit Escapes FCA Suit Over Off-Label Marketing (Law 360-$)
  • St. Vincent Healthcare Workers Honored by FDA for Medwatch Reporting (KULR8)
  • Devon Medical Products Announces FDA 510(k) Clearance of Foam Wound Dressing Kit for extriCARE 2400 Negative Pressure Wound Therapy Portable Pump (Press)

US: Dietary Supplements

  • Researchers Call on State Attorneys General to Increase Regulation of Dietary Supplements (NPI)
  • Mass spectrometric analysis of pharmaceutical adulterants in products labeled as botanical dietary supplements or herbal remedies: a review (PubMed)
  • 'Natural' industry executive Dan Fabricant speaks out on food, supplements and personal care (Deseret News)
  • Supplement Industry Must Turn Up Volume On Political Spending – Fabricant (Tan Sheet-$)
  • Months after issuing import ban, FDA still working to get kratom off market (NI-USA)

US: Assorted And Government

  • Analysis: Government’s New Doctor Payments Website Worthy of a Recall (ProPublica) (MedPage Today) (Pharmalot)
  • HHS to Release Report on Informed Consent and 45 CFR Part 46 (DHHS)
  • Physician Payments Sunshine Act: Breakdown of Research Payments, Including List of Top Manufacturers (Policy and Medicine)
  • How Much? A Glaxo Goof Remains in the Sunshine Database (Pharmalot)

Upcoming Meetings

Ebola Outbreak

  • WHO Provides Extensive Situation Breakdown on Ebola, Treatments (WHO)
  • GlaxoSmithKline, NewLink working to bring Ebola vaccines online: WHO (Reuters) (SCRIP-$)
  • U.S. Will Increase Production of the Ebola Drug ZMapp, but May Not Meet Demand (NYTimes)
  • U.S. nears solution for safe disposal of Ebola waste (Reuters)
  • Ebola toll rises while ZMapp drug production takes its time (CBS)
  • Canada vaccine shipped to Geneva, U.S. hospitals as precaution (Reuters)
  • Experimental Drug Jams Ebola Gene To Fight The Virus (NPR)
  • Dallas braces for second Ebola case (The Hill)
  • Ebola vaccine: Why it's taking so long to make one (CNBC)

Europe

  • European Medicines Agency votes on clinical trial transparency today (All Trials) (EMA)
  • Paying for High-Priced Drugs: Comparing Global Strategies from U.S., UK, and Scotland (Context Matters)
  • Landmark UK patent law change will boost clinical research (PharmaTimes)
  • Lundbeck's alcohol consumption pill gets NHS green light (PharmaTimes)
  • Two hardliners among EU Parliament’s shadow rapporteurs for device reg file (Clinica-$)
  • Zero-Gravity Suspended Radiation Protection Floor Unit Suits Get European Approval (MedGadget)
  • LoneStar Heart wins CE Mark for hydrogel heart implant (Mass Device)
  • Scotland: NHS, SMC, and HIS Explained (Context Matters)

India

  • India, US to Form Working Group on IP Issues (India Times)

China

  • Health Technology Assessment In China: a friend in need? (SCRIP-$)

Japan

  • Vaniprevir, Edoxaban Among Formal Japan Approvals (PharmAsia-$)
  • Mesoblast cell therapy submitted in Japan (BioCentury)

Canada

  • Health Canada Issues NPN for Sensoril (NPI)

Other International

  • The WHO's "biological qualifier": voluntary or compulsory? (SCRIP-$)
  • APEC boosting blood supply chain as demand surges (APEC)
  • Physician Payments Sunshine: Columbia Seeks to Join Global Transparency Trend (Policy and Medicine)

Clinical Trials

  • HHS to Release Report on Informed Consent and 45 CFR Part 46 (DHHS)

General Regulatory And Interesting Articles

  • Hedge Funds Listen In on Patient Chats for Pharma Bets (Bloomberg)
  • 5 Keys To Protecting Your Medical Device From Cybersecurity Threats (MedDevice Online)
  • Why Doesn't Plan B Work For Heavier Women? (PopSci)
  • Complex regs and unknown markets top API shippers' logistics headaches (In-Pharm)

Regulatory Reconnaissance #412 – 2 October 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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