Regulatory Focus™ > News Articles > Regulatory Recon: European Pharmaceutical Regulator EMA Turns 20 (17 March 2015)

Regulatory Recon: European Pharmaceutical Regulator EMA Turns 20 (17 March 2015)

Posted 17 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: European Pharmaceutical Regulator EMA Turns 20 (17 March 2015)

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

In Focus: US

  • The Everlasting Patent: Is it Hiding in Plain Sight in the 21st Century Cures Act? (FDA Law Blog)
  • Why Congress will end up with a less ambitious 21st Century Cures initiative (BioCentury-$)
  • FDA to Meet to Discuss Licensure of Ebola Vaccines (FDA) (SCRIP-$)
  • New Proposed Requirements for Paragraph IV Certifications and Notice (Lachman)
  • FDA staff finds no new safety problems with Glaxo's asthma drug (Reuters)
  • FDA AdComm to Discuss The Medicines Company's NDA for Cangrelor (FDA)
  • Experts call for transparency on insulin pump problems (Reuters)
  • FDA Warning Prompts Shift In Surgeries on Women (WSJ-$)
  • Aetna CMO: UDIs in claims forms necessary to improve care (Fierce) (Aetna)
  • MITA Adds Regulatory Director To Enhance Standards Efforts (Gray Sheet-$)

In Focus: International

  • EMA Turns 20 Today (EMA)
  • Novartis blood cancer drug Jakavi given EU nod (Pharmafile) (PharmaTimes) (Press)
  • How New European Regulations Could Affect Outsourcing (MDDI)
  • Study: Regulatory Professionals Needs to Focus on HTA Matters Earlier (Press)
  • MHRA: Good manufacturing practice and good distribution practice (MHRA)
  • Japan's PMDA sets 12-month target on drug, device reviews with domestics favored (Fierce)
  • Japanese doctor testifies on inflating placebo counts in Diovan trials (Fierce)
  • China FDA draft rules seek detailed tracking data for exported medical devices (Fierce)

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US: Pharmaceuticals and Biotechnology

  • The Everlasting Patent: Is it Hiding in Plain Sight in the 21st Century Cures Act? (FDA Law Blog)
  • New Proposed Requirements for Paragraph IV Certifications and Notice (Lachman)
  • FDA staff finds no new safety problems with Glaxo's asthma drug (Reuters)
  • FDA AdComm to Discuss The Medicines Company's NDA for Cangrelor (FDA)
  • Drug Makers Need Safe Harbor For Patient-Focused Development, Advocates Say (Pink Sheet-$)
  • Label Design May Affect Risk of Medication Errors in the OR (ICT)
  • FDA’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA Through Process (RPM Report-$)
  • LIGHT Data Release Raises Heavy Issues for Small Sponsors (RPM Report-$)
  • U.S. sterile manufacturer racks up 13 observations in FDA visit (Fierce) (FDA)
  • Wanted: Guidelines for Access to Experimental Drugs (WSJ-$)
  • Surrogate Endpoints In Clinical Trials Bone Of Contention In Cures Draft (IHP-$)
  • After Years Of Delay, Will The FDA Finally Make Safe Our Nation's Blood Supply? (Forbes)
  • NDA Filing Problems Lead to Lawsuit Against Acadia Pharmaceuticals (Press)
  • FDA to Hold Public Meeting on Alternative In Vitro Bioequivalence Pathways (FDA) (FDA)
  • Pfizer's $400M Class Action Settlement Gets Early Nod (Law 360-$)
  • FDA approves Actavis' VIIBRYD 20mg/day dose for adults with MDD (PBR)

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

  • Imbruvica combo meets Phase III endpoint (BioCentury) (Press)
  • Study: More CV Events Reduced With Vytorin vs. Statin Alone (MPR) (Press)
  • Pharmacyclics cancer drug successful as combination therapy: independent panel (Reuters)
  • Coherus Finalizes CHS-1701 BLA Enabling Clinical Program and Initiates Pivotal Pharmacokinetic and Pharmacodynamic Study (Press)
  • Actelion boosted by selexipag data (SCRIP-$)
  • Esperion cholesterol drug succeeds mid-stage study (Reuters)
  • CEO: Akebia trial shows anemia drug spurs 'controlled' response (BizJournal)

US: Pharmaceuticals and Biotechnology: General

  • Gilead's hepatitis C drugs largely cost-effective in U.S (Reuters) (Pharmalot)
  • Weight-Loss Drugs Seek Acceptance From Patients and Physicians (WSJ-$)
  • Doctor outreach at heart of Daiichi Sankyo $39 million Medicaid lawsuit settlement (Fierce)
  • Novartis Pays $12.6M Fine for Giving Inaccurate Pricing Data to Medicare (Pharmalot)
  • Pa. Superior Court Affirms $11M Topamax Ruling (Law 360-$)
  • FTC Says Study Documents Aren't Needed In Actavis Case (Law 360-$)

US: Medical Devices

  • Industry, FDA Coming Together On Risk Management For Marketed Devices (Silver Sheet-$)
  • Experts call for transparency on insulin pump problems (Reuters)
  • FDA Warning Prompts Shift In Surgeries on Women (WSJ-$)
  • Genelex Exec: FDA Too Slow to Regulate LDTs (MDDI)
  • AACC Cautions FDA Against Over-regulating the Genetic Testing Technology Vital to Precision Medicine (AACC)
  • Aetna CMO: UDIs in claims forms necessary to improve care (Fierce) (Aetna)
  • MITA Adds Regulatory Director To Enhance Standards Efforts (Gray Sheet-$)
  • Senator: Getting Medical Devices and Treatments from the Lab to the Patients That Need Them the Most (Senate)
  • Registry data shows Abbott's MitraClip transcatheter valve is performing well in real-world settings (Fierce)
  • A Requiem For Routine Clot Removal During Heart Attacks (Forbes)
  • Too Much Cardiac Testing (NYTimes)
  • Toshiba's Infinix 4DCT Receives FDA Clearance With Aquilion PRIME CT Configuration (Press)

US: Dietary Supplements

  • NPA submits 2nd amicus brief in FTC v. Bayer (NewHope360-$)
  • Supplements Industry Sees Silver Lining in Botanicals Probe (NI-USA)
  • How a Real Testing Lab Tests Herbal Extracts (NPI)
  • Vitamin Shoppe Says Falsely Labeled Product Doesn't Exist (Law 360-$)

US: Assorted And Government

  • Why Congress will end up with a less ambitious 21st Century Cures initiative (BioCentury-$)
  • FDA Watching For “Unintended Consequences” of 21st Century Cures (RPM Report-$)
  • A Fitting Farewell: Hamburg Earns Praise From Rep. Rogers In Final Approps Hearing (RPM Report-$)
  • Hamburg Speech on FDA Budget Requests (FDA) (FDA)

Upcoming Meetings and Events

Ebola Outbreak

  • FDA to Meet to Discuss Licensure of Ebola Vaccines (FDA) (SCRIP-$)
  • FDA Grants Emergency Authorization to Roche Ebola Detection Device (FDA)

Europe

  • EMA Turns 20 Today (EMA)
  • Novartis blood cancer drug Jakavi given EU nod (Pharmafile) (PharmaTimes) (Press)
  • Margaret Hamburg on the EMA at 20: An ever stronger bilateral partnership with the US FDA (SCRIP-$)
  • How New European Regulations Could Affect Outsourcing (MDDI)
  • Study: Regulatory Professionals Needs to Focus on HTA Matters Earlier (Press)
  • The EMA at 20: Twenty years of success - the EMA and the European medicines agencies regulatory network (SCRIP-$)
  • MHRA: Good manufacturing practice and good distribution practice (MHRA)
  • European Commissioner for Health and Food Safety visits EMA (EMA)
  • General Court confirms orphan drug data exclusivity (TaylorWessing)
  • UK, Drugmakers Establish $100M Alzheimer's Venture Fund (AP) (SCRIP-$)
  • Electronic common technical document v4.0 draft European Union module 1 implementation guide public consultation (EMA) (Exalon)
  • Volcano Receives CE Mark For iFR Scout Pullback Software To Help Diagnose Serial Lesions And Diffuse Coronary Disease (MedDeviceOnline)
  • VAXIL Receives EU Orphan Drug Designation for ImMucin for the Treatment of Multiple Myeloma (Press)
  • Tuberculosis and superbug strains 'ravaging' Europe, WHO warns (Reuters)

India

  • Government to launch huge media campaign on immunisation from March 23 (India Times)
  • Over 12% meds brought into Maharashtra sub-standard, admits Maharashtra government; says action taken (DNA India)
  • After shortage, government buys condoms from open market (India Times)
  • India and China gear up for trade talks with a pharma focus (Fierce)
  • Indian efforts on pricing of patented drugs gather steam? (SCRIP-$)

Japan

  • Japan's PMDA sets 12-month target on drug, device reviews with domestics favored (Fierce)
  • Japanese doctor testifies on inflating placebo counts in Diovan trials (Fierce)
  • Astellas Submits Supplemental New Drug Application for Kiklin Capsules, a Treatment for Hyperphosphatemia, in Japan (Press)

China

  • China FDA draft rules seek detailed tracking data for exported medical devices (Fierce)

Canada

  • Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals on Human Use (ICH) Guidance: M8 - Electronic Common Technical Document: Implementation Guide (Health Canada)

Other International

  • General's Prosecutor Office inspects Russian business of Abbott (PharmaLetter-$)

Clinical Trials

  • Apple's ResearchKit: Five Guidelines for Pharma (MM&M)
  • Informed Consent and Health Literacy: Workshop Summary (IOM)
  • New PhRMA Report on Clinical Trials (PhRMA)

General Regulatory And Interesting Articles

  • Social Media Used to Discover Unnoticed Side Effects of Drugs (MedGadget)
  • Medtronic heart monitors used in black bear study (Mass Device)
  • Old blood as good as fresh in patients with life-threatening illnesses (Press)
  • Implanted heart valve safe for low-risk patients: Danish study (Reuters)

Regulatory Reconnaissance #515 – 17 March 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.


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