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  • Regulatory NewsRegulatory News

    FDA: What's Slowing Progress in Some Disease Areas?

    In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology. Why are There Effective Treatments for Some Diseases and not Others? Califf raises this question, and points to some diseases like HIV/AIDS, where advances in scientific understanding hav...
  • Regulatory NewsRegulatory News

    European Commission Says Compulsory Licensing can Only Happen at National Level

    After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license. Background In the past two years, drugmakers have launched several drugs to treat hepatitis C (HCV), a disease which left untreated can lead to cirrhosis or liver cancer. The new generation of HCV treatments, led by Gilead's Sovaldi and Harvoni, are highly eff...
  • Regulatory NewsRegulatory News

    HCV, Cancer Drugs Added to Essential Medicines List as WHO Calls for Lower Prices

    The World Health Organization (WHO) has issued a loud call for improving access to several high-profile—and high-cost—medicines by placing them on its 19th Model List of Essential Medicines released today. The updated list features 36 new medicines, including treatments for tuberculosis, HIV, hepatitis C (HCV) and cancer, and signifies a shift in WHO's approach to securing access to new and innovative medicines. Background For nearly 40 years, WHO has maintained...
  • Regulatory NewsRegulatory News

    Gilead to Offer Free HCV Treatment in Georgia

    Gilead Sciences has launched an initiative to provide its hepatitis C (HCV) treatment Sovaldi to patients in the Republic of Georgia free of charge. The move is part of an effort by Gilead to demonstrate that its products can drastically reduce HCV prevalence, which the company hopes will encourage more widespread use of Sovaldi and its successor, Harvoni. In its first year, the program will cover treatment for 5,000 patients, with Gilead looking to expand the program t...
  • FDA Places Clinical Hold on BMS Drug after Emergence of Unexpected Adverse Events

    A phase II drug compound under development by Bristol-Myers Squibb for the treatment of hepatitis C has been discontinued after at least one patient death and multiple hospitalizations for adverse events, the company said in a statement . The compound, BMS-986094, a nucleotide polymerase ( NS5B ) inhibitor, had been acquired when BMS purchased Inhibitex , a Georgia-based biopharmaceutical company focused on infectious diseases. In a 23 August statement, BMS said the...
  • 'Misleading' Patient Perspective Smacked Down by FDA in Untitled Letter

    One pharmaceutical company is learning this week that reproducing a patient's story to "mentor" other potential patients may not sit well with US regulatory authorities, regardless of whether it represents the patient's perspective accurately. Cambridge, Massachusetts-based manufacturer Vertex Pharmaceuticals was sent an Untitled Letter by the US Food and Drug Administration (FDA) warning it about its promotion of Incivek (teleprevir), a Hepatitis C (HCV) drug which FD...
  • Novartis Gets Mixed News on MS, HCV Drugs From EMA, FDA

    Swiss pharmaceuticals manufacturer Novartis AG received mixed news from European and American regulators on 18 April, with the European Medicines Agency (EMA) approving its multiple sclerosis drug GIlenya with some additional warnings, and the US Food and Drug Administration (FDA) demanding a phase III trial for its hepatitis C drug alisporivir be halted after safety concerns were raised. EMA's decision on GIlenya came after some concerns about the drug's safety were r...