Regulatory Focus™ > News Articles > Regulatory Recon: NIH Wants More Female Animals in Preclinical Studies (15 May 2014)

Regulatory Recon: NIH Wants More Female Animals in Preclinical Studies (15 May 2014)

Posted 15 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: NIH Wants More Female Animals in Preclinical Studies (15 May 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Policy: NIH to balance sex in cell and animal studies (Nature) (NYTimes) (Bloomberg)
  • Teva Loses Suit Against FDA Over Generic of Copaxone (Bloomberg) (Press)
  • J&J, Bayer Rip FDA's Over-The-Counter Reforms (Law 360-$)
  • Immunotherapy Drugs Show Promise Treating Range of Cancers (WSJ-$) (Reuters)
  • Advocating Pill, U.S. Signals Shift to Prevent AIDS (NYTimes) (Reuters) (NBC) (Bloomberg)
  • FDA to "Soon" Clarify Position on 3-D Printing (MDS) (Plastics News)
  • Report: FDA's device fast track could cut approval time by one-third (Fierce)
  • Direct-to-consumer genetic testing: a case of potential harm (Mass Device)

In Focus: International

  • European Medicines Agency and European Chemicals Agency enhance cooperation (EMA)
  • ABPI issues third version of its biosimilar position paper (Biosimilar News)
  • Anti-nausea drugs pose risk of potentially fatal syndrome: Health Canada (Globe and Mail) (Health Canada)

US: Pharmaceuticals/Biotechnology

  • Policy: NIH to balance sex in cell and animal studies (Nature) (NYTimes) (Bloomberg)
  • Teva Loses Suit Against FDA Over Generic of Copaxone (Bloomberg) (Press)
  • Drug Shortages: The Scary Reality of a World Without Meds (RD)
  • Some progress on antimicrobial resistance, but much work unfinished (SCRIP-$) (CDC) (EMA) (EC)
  • Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop (FDA Law Blog)
  • J&J, Bayer Rip FDA's Over-The-Counter Reforms (Law 360-$)
  • TEA Changes, GRASE Basics Central To CHPA Monograph Recommendations (Tan Sheet-$)
  • Wockhardt Recalling 110,000 Metoprolol Bottles Due to Dissolution Problems (FDA) (Reuters) (Bloomberg)
  • Generic Gleevec Coming to US in February 2016 (PharmAsia-$)
  • FDA Roadmap to Patient-Focused Outcome Measurement in Clinical Trials Available on Apple iPhones and iPads (Press)
  • NCATS Advisory Council Working Group to release findings about IOM’s report on CTSA Program (Press)
  • Hospira Announces Voluntary Nationwide Recall Of One Lot Of Dobutamine Injection, USP, 250 MG, 20 ML, Single-Dose Fliptop Vial, Due To Visible Particulates (Press)
  • BIO Urges Governor Markell to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines (Press)

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

  • Immunotherapy Drugs Show Promise Treating Range of Cancers (WSJ-$) (Reuters)
  • AstraZeneca cancer drug hailed as 'great white hope' in fight against illness (Guardian) (Bloomberg)
  • Lilly's Necitumumab Improves Overall Survival In Largest Ever Phase III Study In First-Line Treatment Of Stage IV Squamous Non-Small Cell Lung Cancer (Press)
  • Amgen’s Monoclonal Antibody Slashes LDL-C (Press)
  • What we learned from the big ASCO cancer drug data dump (Fierce)
  • BMS PD-1 immunotherapy nivolumab dubbed 'breakthrough' by FDA (SCRIP-$) (Press)
  • Roche immuno-oncology drug shows promise against bladder cancer (Reuters)
  • New analysis shows Boehringer Ingelheim’s Giotrif (afatinib) is the first treatment to demonstrate significant overall survival benefit for patients with a specific type of lung cancer (Press)
  • More Than 5,000 abstracts hit the wire ahead of ASCO (Pharma Times)
  • Vertex faces 'seminal' moment with pending cystic fibrosis drug data (BioFlash)

US: Pharmaceuticals and Biotechnology: General

  • Advocating Pill, U.S. Signals Shift to Prevent AIDS (NYTimes) (Reuters) (NBC) (Bloomberg)
  • Five Facts About the Value of Innovative Cancer Medicines (PhRMA)
  • Couple who ran wholesaling scam plead guilty (Fierce)

US: Medical Devices

  • FDA to "Soon" Clarify Position on 3-D Printing (MDS) (Plastics News)
  • Report: FDA's device fast track could cut approval time by one-third (Fierce)
  • Direct-to-consumer genetic testing: a case of potential harm (Mass Device)
  • FDA scolds online penis, clitoris pump maker (Mass Device) (FDA)
  • Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy (MedScape)
  • Guided Therapeutics preps for a third shot at FDA approval for its cervical scanner (Fierce)
  • Massachusetts Bill Would Restrict Sales of Medical Devices in Physician Offices (MA)
  • Public Workshop – Hemostatic Medical Devices for Trauma Use, September 3-4, 2014 (FDA)
  • Summary of the Ophthalmic Devices Panel Meeting (FDA)
  • Recall of 60,000 Alaris Infusion Pumps due to Software Issue (FDA)

US: Dietary Supplements

  • Is a lack of GLPs for supplements a hindrance for the testing industry? (NI-USA)
  • Diet Drugs' Maker To Pay $40M, Issue Recall Over Labeling (Law 360-$)

US: Assorted And Government

  • FDA Enforcement Report (FDA)

Europe

  • European Medicines Agency and European Chemicals Agency enhance cooperation (EMA)
  • ABPI issues third version of its biosimilar position paper (Biosimilar News)
  • EMA: Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (EMA)
  • EFPIA Urges Drug Makers To See Value In Mobile Apps (Pink Sheet-$)

Japan & China

  • China bribery claims: GSK may not want to stay if punishment seems unfair (Guardian)

Other International

  • Anti-nausea drugs pose risk of potentially fatal syndrome: Health Canada (Globe and Mail) (Health Canada)
  • Health Canada Concludes Safety Review of Diane-35, Serotonin Blocking Drugs (Health Canda)
  • BIOCAD announces the final approval of rituximab biosimilar in Russia (Biosimilar News)

General Regulatory And Interesting Articles

  • The Complicated Question of Drugs in the Water (PBS)
  • Pharmaceutical Industry Reeling As More Moms Making Vaccines At Home (Humor) (The Onion)
  • BMJ Articles Critical Of Statins Provoke Kerfuffle (Forbes)
  • Study: Antidepressant may cut Alzheimer's protein (AP)

Regulatory Reconnaissance #319 – 15 May 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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.


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