• Regulatory NewsRegulatory News

    EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug

    A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals. “The risk in the canagliflozin groups was 6 per 1000 patient years, compared with 3 per 1000 patient years with placebo,” the regulators and Janssen UK and Ireland’s medical director ...
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    RAPS Launches Global Survey of Regulatory Professionals' Work and Compensation

    RAPS has just launched its biennial global survey of regulatory professionals who work with healthcare and related products. RAPS’ Scope of Practice & Compensation Survey of the Regulatory Profession , conducted every two years, is the largest and most comprehensive survey of professionals in this important field, vital to ensuring healthcare products are safe and effective. Respondents work in the pharmaceutical, biotechnology and medical device industries, governme...
  • Regulatory NewsRegulatory News

    WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

    A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...
  • Feature ArticlesFeature Articles

    Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective

    This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview. Introduction The professional field of regulatory advertising and promotion has become increasingly essential to pharmaceutical companies because of the increased volume of advertisements and promotional materials available to them as well as accessibility to a wide variety of different advertisi...
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    J&J’s Regulatory Executives Groomed as Business Leaders

    Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study . Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and crea...
  • Regulatory NewsRegulatory News

    ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

    • 21 July 2014
    In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not —have. Background In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that US Food and Drug Administration (FDA), the Office of the National Coordinator (ONC) for Health IT and the Federal Communication Commission all work...
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    US Supreme Court Decision in Myriad: Are Genes Patentable?

    • 13 August 2013
    The pharmaceutical and life sciences industries waited anxiously for the Supreme Court's decision in Association of Molecular Pathologists v. Myriad Genetics (" Myriad") 1 The high court's decision, handed down 13 June 2013, will have a significant impact on the pharma and device industries as they relate to human genes and genetic material. The decision found that naturally occurring genes cannot be patented, but synthetically produced genetic material remains patent...
  • J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece

    On Wednesday, the US Food and Drug Administration (FDA) released the text of a new Untitled Letter sent to Johnson & Johnson - the second sent in as many months to the same company - regarding promotional material for its blockbuster anticoagulant Xarelto (rivaroxaban), alleging that the company failed to present the risks of the drug in a fair and balanced manner. Background: Doxil Untitled Letters are less serious than the more widely-known Warning Letters, whic...
  • BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable

    In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is. Background The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of th...
  • Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

    The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...
  • Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants

    • 29 January 2013
    At the beginning of 2012, The New York Times made something of a sensational claim: Johnson & Johnson had worked to privately phase out its now-controversial metal-on-metal hip implants in 2009 after US regulators approached the company with concerns about their durability and patient safety. In response to that report, the company indicated that the two events were "unrelated," but now new and potentially troubling information is emerging from a Los Angeles cou...
  • WSJ: Johnson & Johnson Looks to Ease Drug Shortages through Shared Manufacturing Plan

    • 09 October 2012
    A long-running drug shortage involving Johnson & Johnson's anti-cancer drug Doxil (doxorubicin) may be on the verge of easing after the company applied to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new, shared manufacturing method. The root of Doxil's shortages is a " voluntary shutdown " of an Ohio facility run by Ben Venue Laboratories, a contract manufacturer working for J&J, after a November 2011 i...