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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Heart Failure Treatment Endpoints

    As heart failure afflicts 6.5 million in the US, the Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s current thinking on developing drugs to treat heart failure. While noting that there are no effective treatments for heart failure with preserved ejection fraction (HFpEF), which represents about 50% of heart failure cases, FDA says up front that the 7-page draft has two purposes: to make clear that an effect on symptoms or physical...
  • Regulatory NewsRegulatory News

    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
  • Regulatory NewsRegulatory News

    Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria

    A team of researchers say that no currently available patient-reported outcomes for heart failure meet the US Food and Drug Administration's (FDA) criteria for supporting product approval. In a recently published review in the Journal of the American College of Cardiologists , the researchers checked the patient-reported outcomes against nine criteria adapted from the 14 listed in FDA's 2009 guidance, Patient-Reported Outcome Measures: Use in Medical Product Developme...
  • Regulatory NewsRegulatory News

    EMA Offers New Draft Guidance on Developing Treatments for Chronic Heart Failure

    The European Medicines Agency (EMA) on Thursday released new draft guidance for public consultation on the clinical development of new drugs to treat chronic heart failure (CHF). The new draft is meant to update previous guidance, known as “Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure,” in order to differentiate the types of heart failure between reduced and preserved ejection fraction, call for companies to inclu...
  • FDA Says Sponsors of Chronic Fatigue Syndrome Drugs can Rely on Patient-Reported Outcomes

    The US Food and Drug Administration (FDA) has released a new draft guidance document intended to expedite the development of drugs to treat chronic fatigue syndrome (also known as myalgic encephalomyelitis)-a poorly understood condition that has recently been subject to significant interest by FDA regulators. Background Chronic fatigue syndrome (CFS) affects patients by causing severe, persistent and often debilitating fatigue. Little is known about the underlying cause...
  • FDA Presses BMS to Investigate Association Between Diabetes Drug Onglyza and Heart Failure

    The US Food and Drug Administration (FDA) announced Tuesday that it is initiating an investigation into the safety of saxagliptin, a diabetes drug, and its association with heart failure. Background Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is marketed under the trade names Onglyza and Kombiglyze XR (saxagliptin and metformin) by Bristol-Myers Squibb (BMS), its manufacturer, and AstraZeneca. The drugs are FDA-approved as an adjunct to diet and exe...
  • EMA Releases Draft Guideline on Acute Heart Failure Therapies

    The European Medicines Agency (EMA) has released a new draft guideline detailing what information it expects of sponsors developing new therapies to treat acute heart failure (AHF). The guideline , released 15 October, is intended to fill in gaps in its chronic heart failure guidance, explained EMA. AHF is composed of what EMA refers to as a "wide spectrum of symptoms and signs, accompanied by hemodynamic abnormalities and neuroendocrine activation that arise secondary...
  • UK NICE Gives Green Light to Servier's Procoralan for Chronic Heart Failure

    The UK's National Institute for Health and Clinical Excellence (NICE) on 7 August issued draft guidance recommending French drugmaker Servier Laboratories' cardiovascular drug Procoralan (ivabradine) be used by the National Health Service (NHS). In clinical trials, ivabradine has been shown to reduce mortality and improve quality of life in patients with certain forms of chronic heart failure. The draft guidance recommends ivabradine as an option for the treatment...
  • Feature ArticlesFeature Articles

    Pythons—A Model to Study Human Heart Disease?

    • 15 June 2012
    • By
    Many of my previous articles for RAPS have featured a host of disparate animals that are or could be used in medicine or in medical research, including leeches, maggots, rats, spiders, whipworms, Gila monsters and zebrafish. Now, there is new evidence to include Burmese pythons on this distinguished list. This snake species may be used to develop drugs to treat human heart disease. 1 In anticipation of this event, it would be prudent to know more about  Burmese pyth...
  • Reviewers Express Doubts in Advance of Xarelto Review

    An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug. CNBC reports the panel of advisors was particularly troubled by missing data , including 12% of patients in the study and several deaths which were not counted in ...
  • ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, providing four new pieces of insight on the clinical evaluation of non-antiarrhythmic drugs. ICH's Q&A document for E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs was originally released under Step 4 o...