Regulatory Focus™ > News Articles > Regulatory Recon: Do Cancer Trials Under-Report Side Effects? (13 February 2015)

Regulatory Recon: Do Cancer Trials Under-Report Side Effects? (13 February 2015)

Posted 13 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Do Cancer Trials Under-Report Side Effects? (13 February 2015)

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

In Focus: US

  • Clinical trials may under report side effects of cancer drugs (Reuters)
  • Clinical-trial specialist could be next FDA chief (Nature)
  • NIH Extends Comment Period on Clinical Trials Registration Rule (NIH)
  • FDA approves Eisai's Lenvima for a type of thyroid cancer (FDA)
  • Painkiller in Short Supply Following Hospira Recall (WSJ-$)
  • Woodcock Reflects on 2014 and What's Ahead for 2015 (FDA)
  • FDA permits marketing of fecal incontinence device for women (FDA)
  • Cepheid Receives FDA Clearance for Expanded Claims on Tuberculosis Test (FDA) (Press)
  • Risk Principles and Medical Devices: A Post-Market Perspective (AAMI)
  • DNA Testing of Herbal Supplements - Does it Work or Doesn't It? (USP)

In Focus: International

  • PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines (EMA)
  • Switzerland rejects allegations it offers drug fakers easy route to the EU (In-Pharma)
  • EC Authorizes Use of Zoetis' Cattle Drug Zulvac (EC)
  • NICE issues fresh rejection for Celgene’s cancer drug Imnovid (PMLive) (PharmaTimes)
  • France fights to prevent approval of Orexigen's obesity drug (SCRIP-$)
  • Harper Government launches new online tool for drug safety information (Press) (Website)
  • Canada gets strict on commercial reprocessing of single-use medical devices (SCRIP RA-$)

Sponsored Message: Learn About China's New Medical Device Regulations

  • China’s growing medical device market is the 3rd largest in the world. Learn about the new medical device regulations that went into effect on 1 October 2014 and how they impact foreign medical device manufacturers registering their products in China. The webcast will also focus on the challenges and best practices for executing clinical trials in China and how to avoid them.
  • Join RAPS, Wednesday, 18 February for New China Medical Device Regulations: Best Practices for Clinical Trials.

US: Pharmaceuticals and Biotechnology

  • FDA approves Eisai's Lenvima for a type of thyroid cancer (FDA)
  • Painkiller in Short Supply Following Hospira Recall (WSJ-$)
  • Woodcock Reflects on 2014 and What's Ahead for 2015 (FDA)
  • Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex (FDA Law Blog)
  • We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing” (FDA Law Blog)
  • FDA Globalization Capacity, Shortage Monitoring Remain Concerns, GAO Says (Pink Sheet-$) (GAO)
  • Improving Pharmaceutical Innovation by Building a More Comprehensive Database on Drug Development and Use (HealthAffairs)
  • Background Analysis: US FDA Advisory Committee to Review GlaxoSmithKline’s Breo Ellipta (Tarius)
  • Will FDA advisers shoot down Amgen's cancer vaccine? (Fierce)
  • High-Dose Flu Vaccine More Effective in Older Adults (PubMed)
  • CMPI Starting Push to "Promote Earlier Access" to Drugs for Terminally Ill Patients (Press)
  • Takeda Ordered to Pay $2.3 Million in Damages to Actos User (Bloomberg)
  • Appeals court rules for Lupin, against Teva over generic HIV drugs (Reuters)

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

  • FDA to review Hospira's EPO biosimilar (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Senator Introduces Bill to Ban Comparative Effectiveness Research (Senate)

US: Medical Devices

  • FDA permits marketing of fecal incontinence device for women (FDA)
  • Cepheid Receives FDA Clearance for Expanded Claims on Tuberculosis Test (FDA) (Press)
  • Risk Principles and Medical Devices: A Post-Market Perspective (AAMI)
  • Presentations from CDRH's Industry Basics Workshop (FDA)
  • Pelvic mesh lawsuits: Boston Scientific wants 700 Philly cases sent to federal court (Mass Device)
  • J&J blinks in vaginal mesh cases, drops complaint over patient solicitation (Fierce)

US: Dietary Supplements

  • DNA Testing of Herbal Supplements - Does it Work or Doesn't It? (USP)
  • NY AG shifts focus & subpoenas retailers on structure-function label claims (NI-USA)
  • Cooperman: AG used wrong test, but that doesn't mean there isn't a quality problem in supplement industry (NI-USA)
  • AHP sends 58-page response to New York AG (NewHope)
  • Allegation of Wrong Identity for Dietary Supplements Means Increased FDA Scrutiny for the Whole Industry (FDAimports)
  • An assay is only as good as the reference material (NI-USA)

US: Assorted And Government

  • Clinical-trial specialist could be next FDA chief (Nature)
  • NIH Extends Comment Period on Clinical Trials Registration Rule (NIH)
  • Study: Physicians Report Few Requests By Patients For ‘Unnecessary’ Treatments (Kaiser) (Bloomberg) (TIE) (Vox)
  • Enforcement Report - Week of February 11, 2015 (FDA)
  • European Medicines Agency/FDA Patient Engagement Fellowship: A Time to Learn and Share (FDA)

Upcoming Meetings

Ebola Outbreak

  • Ebola Epidemic Should End in May, Say Disease Modelers (MIT TR)

Europe

  • PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines (EMA)
  • Switzerland rejects allegations it offers drug fakers easy route to the EU (In-Pharma)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015 (EMA)
  • EC Authorizes Use of Zoetis' Cattle Drug Zulvac (EC)
  • NICE issues fresh rejection for Celgene’s cancer drug Imnovid (PMLive) (PharmaTimes)
  • France fights to prevent approval of Orexigen's obesity drug (SCRIP-$)
  • Italy’s new HTA system signals major change (Clinica-$)
  • MHRA: Hormone replacement therapy (HRT) and the risk of ovarian cancer (MHRA)
  • Boehringer and Sanofi admit to code breaches (Pharmafile)
  • New provisions for the invoicing of inspection expenses (EDQM)
  • Half a million cancer patients in EU use targeted drugs (PMLive)

China

  • For many of China's biotech brains-in-exile, it's time to come home (Reuters)

Canada

  • Harper Government launches new online tool for drug safety information (Press) (Website)
  • Canada gets strict on commercial reprocessing of single-use medical devices (SCRIP RA-$)
  • How Drugs are Reviewed in Canada (Health Canada)
  • Case Study for Health Canada Device License & 11 Steps to Obtain CMDCAS Certification (Eisner)

Other International

  • Saudi labeling guidance: new requirements, but many points should be familiar (Clinica-$)

Clinical Trials

  • Clinical trials may under report side effects of cancer drugs (Reuters)

General Regulatory And Interesting Articles

  • Drug discovery returns to the wild (PharmJournal-$)
  • Stem cells offer promising key to new malaria drugs: U.S. research (Reuters)
  • DARPA and OSRF Developing Next-Gen Prosthetic Limbs in Simulation and Reality (IEEE) (MedGadget)

Regulatory Reconnaissance #493 – 13 February 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 @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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe