Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 September 2013)

Regulatory Reconnaissance (6 September 2013)

Posted 06 September 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

In Focus: International

  • European Medicines Agency's workshop on conflicts of interests today (EMA)
  • ABPI responds to NICE over R&D costs (Pharma Times)
  • EU IP Law Reform Won't Protect Pharma's Commercially Confidential Data (Pink Sheet)
  • Regulatory Approvals Encouraging for Biosimilar Makers, says Coherus (BioPharma Reporter)
  • Medicines regulation reforms in Africa 'incomplete', says WHO (Securing Industry)
  • Industry wary as India proposes Central Drugs Authority, tighter trial regs (SCRIP)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA gives Endo's hypogonadism drug Aveed 2nd chance (SCRIP) (DD&D) (PharmPro) (BioCentury)
  • Indian companies among firms yet to pay annual facility fees to FDA (India Times)
  • Plant in Spain gets warning letter for failing to test products (Fierce)
  • Drug Firms, Patients Push For Strict Limits On Office Use Compounding (IHP)
  • GSK's cancer vaccine fails first Phase III endpoint (SCRIP) (EP Vantage) (PMLive)
  • Mallinckrodt's painkiller successful in late-state trial (Reuters) (Mallinckrodt)
  • Elcelyx's NewMet meets 1st Phase IIb endpoint (SCRIP)
  • Theravance Phase IIb success with GSK-independent COPD drug (SCRIP)
  • Genentech Sues Rivals Over Generic Anti-Viral Drug Plans (Law 360)
  • FDA grants priority review to Takeda's colitis drug (PMLive)
  • Celgene's Phase III Study (MM-003) of Pomalidomide Plus Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma Meets Primary Endpoints (Celgene)
  • Investigational Submicron Diclofenac Reduces Use of Opioid Rescue Medication in Post-Surgical Pain in a Phase 3 Study (Iroko)
  • NCPA Urges House to Ensure Patient Access to Customized Medications As Lawmakers Consider Compounding Pharmacy Oversight Legislation (NCPA)
Pharmaceuticals and Biotechnology: General
Medical Devices
  • Rented Medtronic tools linked to possible CJD exposure in Thirteen Patients (Fierce) (Reuters)
  • FDA Advisors Will Scrutinize CT Colonography Evidence (Gray Sheet) (MedPage Today)
  • App Makers Crowdfund to Avoid Blindside Hit of FDA Rules (Bloomberg)
  • CDRH Issues Draft Guidance on the Applicability of GLPs in Device Submissions (FDA Law Blog)
  • StelKast Receives FDA Clearance of EXp for Proven Gen-Flex Total Knee System (StelKast)
Assorted And Government
  • Is Your TweetChat "Regulation Safe?" Regulators Should Publish Opinions on Specific Social Media Initiatives Such as #COPDChat (Pharma Marketing)
  • Don't Confuse "Made In USA" And "Inspected By FDA" With Patriotism (Life Science Leader)
  • Enforcement Report - Week of September 4, 2013 (FDA)
  • FDA's CFSAN Sets Priorities for Public Health (NPI)
  • Information for Foreign Governments: Frequently Asked Questions on Food Inspection Systems Recognition (FDA) (FDA)
Upcoming Meetings And Events
  • 2-5 September 2013: Pharmacovigilance Risk Assessment Committee (EMA)
  • 5-6 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 5 September 2013: ENVI Meeting on Medicines and Innovation (ENVI)
  • 6 September 2013: EMA Meeting on Best Expertise vs. Conflicts of Interest (EMA) (Agenda)
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Medicines Agency's workshop on conflicts of interests today (EMA)
  • ABPI responds to NICE over R&D costs (Pharma Times)
  • EU IP Law Reform Won't Protect Pharma's Commercially Confidential Data (Pink Sheet)
  • Regulatory Approvals Encouraging for Biosimilar Makers, says Coherus (BioPharma Reporter)
  • Pharma company says info on adverse effects of drugs should be trade secret (AllTrials)
  • EMA to Accept Use of SAFE-BioPharma Digital Signatures on eSubmissions (PR)
  • G-BA now finds benefit for Caprelsa (BioCentury)
  • G-BA rebuffs Lyxumia for Type II diabetes (BioCentury)
  • Bayer seeks to expand Stivarga's EU label (BioCentury)

Asia

  • Industry wary as India proposes Central Drugs Authority, tighter trial regs (SCRIP)
  • GlaxoSmithKline could be considering quitting China, says BBC editor (Pharma Letter)
  • Eisai, Takeda Take Similar Paths To Speed Alzheimer's Drug Approvals (PharmAsia)

Other International

  • Medicines regulation reforms in Africa 'incomplete', says WHO (Securing Industry)
  • International Rx Shortages Summit Urges New Purchasing Models (Pink Sheet)
  • New device maintenance fee schedule announced in Argentina (Mass Device)

General Regulatory And Interesting Articles

  • 3D Printing Is a Matter of Life and Death (Mashable)
  • Social media: boon to business or compliance death trap? (Inside Counsel)
  • Using Infographics to Increase Understanding of Clinical Trials (Eli Lilly)
  • The race for the next-generation of Alzheimer's drugs (NBC)
  • Five-year studies will help decide if genomic analysis should be routine screening for all newborns (Med City News)
  • Human gut microbes alter mouse metabolism, depending on diet (EurekAlert) (CBS) (NPR)
  • Skipping meds linked to more hospital visits for kids (Reuters)
  • A Biotech King, Dethroned (NYTimes)

Regulatory Reconnaissance #147  - 6 September 2013

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.


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