Regulatory Focus™ > News Articles > Regulatory Recon: EMA Recommends 11 New Medicines (24 April 2015)

Regulatory Recon: EMA Recommends 11 New Medicines (24 April 2015)

Posted 24 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: EMA Recommends 11 New Medicines (24 April 2015)

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

In Focus: US

  • FDA Extends Comment Period on 505(b)(2) Application Rule (FDA)
  • Novartis Heart Failure Combo LCZ696 Might Skip FDA Advisory Cmte. (Pink Sheet-$)
  • Antibiotics shortages could put patients at risk from superbugs (CBS)
  • Hospira's New Whitepaper on Biosimilar Extrapolation (Hospira)
  • CDRH Hiring New Director of the Office of Compliance (CDRH)
  • Fitzpatrick To FDA: It's Time For Conversation About Medical Device Safety (IHP-$)
  • FDA Slams Supplement Cos. Over Untested Ingredient (Law 360-$) (Tan Sheet-$) (WSJ-$) (NI-USA) (NYTimes) (Forbes) (Reuters)
  • FDA Enforcement Metrics, FY2009 – FY2014 (Unger Consulting) (FDA)

In Focus: International

  • EMA Recommends Approval of 11 New Medicines (EMA)
  • Bristol wins EU green light for immune system cancer drug (Reuters) (Press) (EMA)
  • Annual ABPI gathering debates affordability solutions (SCRIP-$) (PMLive)
  • First EU treatment for rare sleep-wake disorder, Hetlioz (EMA)
  • Change at the top for regulatory agencies in Greece and Slovenia (Clinica-$)
  • AstraZeneca: UK medicines deal not delivering (PharmaPhorum)
  • World's first malaria vaccine moves closer to use in Africa (Reuters)
  • Drug Review Times Vary Widely from Country to Country (Thomson Reuters)

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US: Pharmaceuticals and Biotechnology

  • FDA Extends Comment Period on 505(b)(2) Application Rule (FDA)
  • Novartis Heart Failure Combo LCZ696 Might Skip FDA Advisory Cmte. (Pink Sheet-$)
  • Antibiotics shortages could put patients at risk from superbugs (CBS)
  • Hospira's New Whitepaper on Biosimilar Extrapolation (Hospira)
  • FDA's breakthrough status: an investment magnet (SCRIP-$)
  • FDA Appears to be Expediting Reviews of Some ANDAs (Lachman)
  • The next bend up in the cost curve: Rising prices for old proven drugs? (Running a Hospital)
  • Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Bupivacaine HCl Injection Due To Potential Iron Oxide Particulate In Glass Vials (FDA)

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

  • Merck's breakthrough HCV drug aces trial (PMLive) (Press) (MM&M) (SCRIP-$)
  • U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C (Press)
  • GW Pharmaceuticals Receives Orphan Drug Designation From FDA for Cannabidiol for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (Press)
  • FDA Grants Orphan Drug Designation for DCR-PH1, Dicerna’s Investigational Therapy for the Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
  • POMALYST (pomalidomide) Label Update Including Progression-Free and Overall Survival Benefits Approved by U.S. FDA (Press)
  • Aerie shares crushed after glaucoma therapy flops in PhIII (Fierce) (Reuters)
  • Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir Plus Sofosbuvir in Genotype 1 HCV Patients With and Without Cirrhosis (Press)

US: Pharmaceuticals and Biotechnology: General

  • H.R. 1821 - Opioid Overdose Reduction Act Of 2015 (Congress)

US: Medical Devices

  • CDRH Hiring New Director of the Office of Compliance (CDRH)
  • Fitzpatrick To FDA: It's Time For Conversation About Medical Device Safety (IHP-$)
  • FDA approves Siemens 3D breast tomo device (MassDevice) (Fierce)
  • Medtronic facing new wrongful death lawsuit over failed insulin pump in wake of 2009 recall (Fierce)
  • FDA Classifies Recall of Unapproved, Uncleared Ebola Detection Devices as Class 1 (FDA)
  • Nipro Diagnostics Announces FDA Clearance of TRUE METRIX AIR (Press)
  • Class 1 Recalls for Two Medical Devices (FDA) (FDA)

US: Dietary Supplements

  • FDA Slams Supplement Cos. Over Untested Ingredient (Law 360-$) (Tan Sheet-$) (WSJ-$) (NI-USA) (NYTimes) (Forbes) (Reuters)
  • NYAG affair may ultimately serve to reinforce smaller retailers' quality message, execs say (NI-USA)
  • Stopping unfair competition from unlawful ingredients and products at the border (NI-USA)

US: Assorted And Government

Upcoming Meetings and Events

Europe

  • EMA Recommends Approval of 11 New Medicines (EMA)
  • Bristol wins EU green light for immune system cancer drug (Reuters) (Press) (EMA)
  • Annual ABPI gathering debates affordability solutions (SCRIP-$) (PMLive)
  • First EU treatment for rare sleep-wake disorder, Hetlioz (EMA)
  • Change at the top for regulatory agencies in Greece and Slovenia (Clinica-$)
  • EMA recommends avoidance of certain hepatitis C medicines and amiodarone together (EMA)
  • Codeine not to be used in children below 12 years for cough and cold (EMA)
  • AstraZeneca: UK medicines deal not delivering (PharmaPhorum)
  • Version 2.1 of the HTA Core Model® available (EUnetHTA)

India

  • Mylan Pharmaceuticals launches generic hepatitis C drug MyHep in India (India Times)
  • Health ministry to come out with national list of medical devices soon (PharmaBiz)

Japan

  • Bayer Submits Marketing Authorization for Radium-223 Dichloride to Treat Prostate Cancer with Bone Metastases in Japan (Press)

China

  • New CFDA Chief Appointed (Xinhua)
  • China proposes patent law changes to toughen IP protection (Fierce)

Canada

  • New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses (HealthCanada)
  • J&J recalls contraceptives for subpotency (Fierce)

Australia

  • Reduction of assessment fees for medical devices (TGA)

Other International

  • World's first malaria vaccine moves closer to use in Africa (Reuters)
  • Drug Review Times Vary Widely from Country to Country (Thomson Reuters)
  • WHO's new global medtech regulatory model will change international devices scene (Clinica-$)
  • Big Medical Device Makers Form Their First Industry Trade Group in Asia (Pharmalot)

General Regulatory And Interesting Articles

  • Measuring mAbs with magnetic resonance can help regulatory testing (BioPharma-Reporter)
  • Regulatory Compliance Challenges in a Global Economy (PCM)
  • New gel medication breakthrough delays release of drug to benefit the patient (MNT)
  • Common asthma steroids linked to side effects in adrenal glands (Reuters)

Regulatory Reconnaissance #543 – 24 April 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

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