Regulatory Focus™ > News Articles > Regulatory Recon: Risk of Brain Deposits Prompts FDA to Calls for Limiting Gadolinium-Based Contrast

Regulatory Recon: Risk of Brain Deposits Prompts FDA to Calls for Limiting Gadolinium-Based Contrast Use (28 July 2015)

Posted 28 July 2015 | By Michael Mezher 

Regulatory Recon: Risk of Brain Deposits Prompts FDA to Calls for Limiting Gadolinium-Based Contrast Use (28 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

  • FDA Examines Whether MRI Drugs Accumulate in Brain Tissue (ProPublica) (MedpageToday) (FDA) (FDA)
  • Some serious drug side effects not told to FDA within 15 days (Reuters) (SCRIP-$)
  • Praluent Looks Cheap to Those With Extreme Cholesterol (NYTimes)
  • FDA forestalls unpopular payer decisions on PCSK9s (EP Vantage-$)
  • Could generic breast cancer combo be more effective than wonder drug tamoxifen? (Washington Post)
  • FDA recall notice issued for nearly 2,000 Medtronic MiniMed insulin pumps (FierceMedicalDevices)
  • 21st Century Cures: Myth-Fact (USHR)
  • Senate chance to improve 'Cures,' but don't expect soon (SCRIP-$)
  • GpHA, Biosimilars Council pen open letter to President Obama on TPP (DSN)

In Focus: International

  • Fast track routes for medicines that address unmet medical needs (Press Release) (Draft) (EMA)
  • EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences (FiercePharmaAsia) (Pharmalot)
  • European Guidance on IFU for Sterilizing Medical Devices (Emergo)
  • UK May Require Doctors to Report Their Financial Ties to Drug Makers (Pharmalot)
  • India may contest EU move to ban 700 drugs (Economic Times)
  • WHO urges India to stick to safety guidelines for hepatitis prevention (Economic Times)
  • China: Drugmakers Told to Verify GCP (FDANews-$)

US: Pharmaceuticals and Biotechnology

  • Some serious drug side effects not told to FDA within 15 days (Reuters) (SCRIP-$)
  • FDA Examines Whether MRI Drugs Accumulate in Brain Tissue (ProPublica) (MedpageToday) (FDA) (FDA)
  • Praluent Looks Cheap to Those With Extreme Cholesterol (NYTimes)
  • FDA forestalls unpopular payer decisions on PCSK9s (EP Vantage-$)
  • Could generic breast cancer combo be more effective than wonder drug tamoxifen? (Washington Post)
  • Teva recalls lots of Adrucil in USA (PharmaLetter-$) (FDA)
  • Moses Lake Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance (FDA)

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

  • Lilly continues test of HDL cholesterol drug, on panel's advice (Reuters) (Press) (FierceBiotech) (PharmaLetter-$)
  • Merck Submits NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4 and 6 (Press)
  • FDA Grants Breakthrough Therapy Designation to Eisai's Lenvatinib for the Potential Treatment of Metastatic Renal Cell Carcinoma (Press)
  • Kerastem Receives Conditional Approval from FDA for Alopecia Trial (Press)

US: Pharmaceuticals and Biotechnology: General

  • Survey Shows Need for Greater Consistency in “Real World” Observational Research (Press)
  • Cancer Docs Price Control Prescription Is Misinformed (DrugWonks)
  • More people should be taking statins for primary prevention, US study suggests (PJ Online)
  • The next phase in transplant medicine (Press)
  • No Benefit from Chemo at End of Life (MedpageToday)

US: Medical Devices

  • FDA recall notice issued for nearly 2,000 Medtronic MiniMed insulin pumps (FierceMedicalDevices)
  • Essential Medical launches Manta device trial (MassDevice)
  • FDA uses previous trial data to design faster study of certain ablation devices (FierceMedicalDevices)

US: Assorted and Government

  • 21st Century Cures: Myth-Fact (USHR)
  • Senate chance to improve 'Cures,' but don't expect soon (SCRIP-$)
  • GpHA, Biosimilars Council pen open letter to President Obama on TPP (DSN)
  • FDA and FTC to address key industry concerns at CRN Conference (DSN)
  • US Senate bill aimed at streamlining combination product regulation (Clinica-$)
  • 21st Century Cures bill doesn't push innovation far enough, policy group says (Modern Healthcare)
  • GAO IDs 3 ways DEA can improve communications with pharmacists, manufacturers (DSN) (GAO)
  • Biolitec takes $75m AngioDynamics beef to the Supremes (MassDevice)
  • Medtronic asks Supremes to review loss to NuVasive (MassDevice)

Upcoming Meetings and Events

Europe

  • Fast track routes for medicines that address unmet medical needs (Press Release) (Draft) (EMA)
  • EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences (FiercePharmaAsia) (Pharmalot)
  • European Guidance on IFU for Sterilizing Medical Devices (Emergo)
  • UK May Require Doctors to Report Their Financial Ties to Drug Makers (Pharmalot)
  • Public consultation on the HTA Core Model for rapid Relative Effectiveness Assessments (EUnetHTA)
  • Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (EMA)
  • Merck Receives Positive CHMP Opinion for Investigational Antibiotic ZERBAXA (Press)
  • CHMP recommends approval of isavuconazole in the EU (EuropeanPharmaceuticalReview)
  • Sanofi says new data analyses support its dengue vaccine (Reuters)
  • EMA Validates Teva's Reslizumab Marketing Authorization Application (Press)
  • Two rival treatments for multiple myeloma have been granted 'accelerated assessment' by Europe's medicines regulator (PharmaPhorum)
  • Tafinlar and Mekinist combination therapy achieves regulatory milestones (EuropeanPharmaceuticalReview)
  • EMA accelerated assessment for Takeda’s ixazomib for MM patients (PharmaLetter-$) (EuropeanPharmaceuticalReview)
  • CHMP recommends Revolade for severe aplastic anaemia (EuropeanPharmaceuticalReview)
  • Undercover Report on Industry Relationship With NHS Inspires Discussion For UK Sunshine Law (Policy and Medicine)

India

  • India may contest EU move to ban 700 drugs (Economic Times)
  • WHO urges India to stick to safety guidelines for hepatitis prevention (Economic Times)
  • India may suffer Rs 6,300 crore loss in pharma exports (Economic Times)

China

  • China: Drugmakers Told to Verify GCP (FDANews-$)

Canada

  • KYTHERA Biopharmaceuticals gains Health Canada OK of Belkyra/Kybella (PharmaLetter-$)
  • Summary Basis of Decision: Keytruda (Health Canada)

Australia

  • Submissions received: Orphan drugs program (TGA)
  • Australia Gearing Up For More Price Cuts This Year And Next (PharmAsiaNews)

Other International

  • Fight Against Tropical Diseases Is Framed as Efficient (NYTimes)
  • Africa risks large meningitis outbreak (WHO)
  • Indian, African experts to participate in HIV-AIDS conference (Economic Times)
  • Turkey Firms Up More Positive Policies As It Seeks Biotech Boost (PharmAsiaNews)

General Health and Interesting Articles

  • Imperfect vaccines could make viruses more dangerous, at least in chickens (Washington Post)

Regulatory Reconnaissance #605– 28 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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