Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Amgen's Heart Failure Drug Corlanor (16 April 2015)

Regulatory Recon: FDA Approves Amgen's Heart Failure Drug Corlanor (16 April 2015)

Posted 16 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Approves Amgen's Heart Failure Drug Corlanor (16 April 2015)

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

In Focus: US

  • FDA approves Amgen's Corlanor for heart failure (BioCentury) (Reuters) (Forbes) (Fierce) (SCRIP-$) (NYTimes) (FDA)
  • FDA panel votes in favor of Medicines Co's blood clot preventer (Reuters) (SCRIP-$) (BioCentury) (Tarius) (Press) (MedPage Today) (Pink Sheet-$)
  • Pacira Receives Subpoena from the U.S. Department of Justice (Press)
  • FDA to Extend Comment Period on Proposed Rule on Abbreviated New Drug Applications and 505(b)(2) Applications (FDA)
  • MDRs to FDA on deadly bacteria outbreaks arrived late (USA Today)
  • Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework (FDA Law Blog)
  • Study Sparks Debate on Accuracy of Genome Tests for Cancer Patients (WSJ-$) (NPR)
  • 21st Century Cures Bill Expected by End of April (IHP-$)

In Focus: International

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US: Pharmaceuticals and Biotechnology

  • FDA approves Amgen's Corlanor for heart failure (BioCentury) (Reuters) (Forbes) (Fierce) (SCRIP-$) (NYTimes) (FDA)
  • FDA panel votes in favor of Medicines Co's blood clot preventer (Reuters) (SCRIP-$) (BioCentury) (Tarius) (Press) (MedPage Today) (Pink Sheet-$)
  • Pacira Receives Subpoena from the U.S. Department of Justice (Press)
  • FDA to Extend Comment Period on Proposed Rule on Abbreviated New Drug Applications and 505(b)(2) Applications (FDA)
  • Otsuka Hits FDA With New Suit Over Abilify Generics (Law 360-$)
  • Amgen Receives No Help from the FDA -- A Biosimilar Update (PatentDocs) (BioCentury)
  • Talk to your doctor: How even annoying DTC ads can contribute to patient communication (BioWorld)
  • Teva Asks Supreme Court Again to Rule on Failure-to-Update Claims (FDAnews-$)
  • FDA Announces Funds Available for IMEDS Research (FDA) (Grant)
  • Bill would let sick kids use marijuana (The Hill) (House)
  • Data Mining FAERS to Analyze Molecular Targets of Drugs Highly Associated with Stevens-Johnson Syndrome (PubMed)
  • FDA’s Patient-Focused Drug Development: The view from the other side of the table (FasterCures)
  • Biosimilar Substitution Bill Introduced in Michigan (Scout)

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

  • Pfizer's Ibrance conquers new breast cancer territory (SCRIP-$) (Reuters) (Fierce)
  • Novartis Announces New Phase 3 Data from CLL Drug Study (Press) (Pharmafile)
  • Repros Announces November 30, 2015 PDUFA Goal Date for New Drug Application (Press)
  • Reata Pharmaceuticals Receives Orphan Drug Designation for Bardoxolone Methyl From the U.S. FDA for the Treatment of Pulmonary Arterial Hypertension (Press)
  • FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis (Press)

US: Pharmaceuticals and Biotechnology: General

  • DTC ad viewers really do ask their doctors about new meds, survey finds (Fierce)

US: Medical Devices

  • MDRs to FDA on deadly bacteria outbreaks arrived late (USA Today)
  • Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework (FDA Law Blog)
  • JAMA article calls for more effective tools to separate good mobile health apps from poor ones (MedCityNews)
  • Study Sparks Debate on Accuracy of Genome Tests for Cancer Patients (WSJ-$) (NPR)
  • First human trial for postpartum bleeding device delivers promising results (Fierce)
  • OriGen Biomedical Issues Nationwide Recall of OriGen VV13F Reinforced Dual Lumen ECMO Catheters (FDA)
  • FDA Clears the Simplexa Group A Strep Direct Test from Focus Diagnostics, a Quest Diagnostics Business (Press)

US: Dietary Supplements

  • Durbin, Blumenthal 'troubled' by FDA inaction on mislabelled supplements (MNT)
  • Attorneys General Acknowledge Questions About DNA Tests But Remain Concerned Over Supplements (NPI)

US: Assorted And Government

  • 21st Century Cures Bill Expected by End of April (IHP-$)
  • Regulatory reform bills clear House panel (The Hill)
  • Exploring the First Federal Register (OFR)

Upcoming Meetings and Events

Europe

  • DG Sanco confirms FMD safety features timeline (Securing Industry) (DG Sanco)
  • Malaria Drug Lariam Blamed for Hundreds of Cases of Psychosis (Independent) (Independent)
  • Guidance to applicants /marketing authorisation holders (MAHs) on oral explanations at EMA (EMA)
  • EC Approves Amgen's Ristempa (Pegfilgrastim) (EC)
  • Report: Policy Stunting Growth of German Pharma Industry (PharmPro)

Japan

  • AbbVie hep C drug gets priority review in Japan (Pharmafile)

Australia

Other International

  • Russia sees slight dip in clinical trial approvals in Q1 2015 (Outsourcing Pharma)
  • Russian drugmakers plan to produce copies of expensive imported drugs (PharmaLetter-$)

General Regulatory And Interesting Articles

  • Rare side effect erased woman's fingerprints (CBS)

Regulatory Reconnaissance #537 – 16 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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