• GSK to Publish Results of All Clinical Trials Conducted since Company's Founding

    • 05 February 2013
    Pharmaceutical manufacturer GlaxoSmithKline is making waves for the second time in the last four months, announcing that in response to a new clinical trials data transparency initiative, it will commit to make all clinical study reports (CSRs) publicly available through its proprietary clinical trials register. Background GSK made a similar announcement in October 2012, when it said that it would soon publish clinical trials data using a secure database available to ...
  • In Shift, GSK to Publish Clinical Trials Data

    • 11 October 2012
    Under fire from industry critics, UK drug manufacturing giant GlakoSmithKline has announced its intent to publish clinical trials data-a first for both the company and the pharmaceutical industry, which has historically guarded such data closely to limit potential risk. In a statement, the company said it intends to share, "Detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patient...
  • GSK Settles Charges, Agrees to Record-Setting Fine

    British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs. In a statement released 2 July , US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupr...
  • New Combination Vaccine Approved by FDA

    A new combination vaccine that protects infants against meningococcal disease and Hib disease received approval from the US Food and Drug Administration (FDA) on 14 June, the agency said. Reuters reports the vaccine, GlaxoSmithKline Biologicals'Menhibrix, had twice been rejected by the agency in both 2010 and 2011 after regulators raised questions about the benefit:risk profile of the product. The questions seemed to be resolved-or at least mitigated-during the product...
  • Suspects Nabbed in Record-Setting Pharmaceutical Heist

    • 08 May 2012
    A pharmaceutical robbery in 2010 had all the trappings of a Hollywood-inspired heist: thieves breaking into a secure facility, tens of millions of dollars in stolen product and a cold trail. Now, that heist is getting something else: an ending. Authorities had been left stunned after a March 2010 heist in Connecticut left $80 million in pharmaceutical products from an Eli Lilly warehouse missing-a heist so large it may be the largest theft of pharmaceutical products in U...
  • UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

    The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April. The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear t...
  • Union of Concerned Scientists Decries Corporate Interference in FDA Decision Making

    Scientific agencies like the US Food and Drug Administration (FDA) are under increasing pressure from "corporate abuse" of the political and legal processes, claims a new report from the Union of Concerned Scientists (UCS). The report, Heads They Win, Tails We Lose , illustrates a number of case studies in which companies sought to influence-often successfully-FDA decision making by exerting pressure through political and legal channels. Of note: "New Jersey company...
  • NICE Fires Back at Witty, Defends Role

    The National Institute for Health and Clinical Excellence (NICE), the UK's health technology assessment (HTA) body, fired back against GlaxoSmithKline (GSK) CEO Andrew Witty after he remarked that the agency is purposefully delaying drugs to save the government money. "We have not been asked to change the basis of our assessments simply to save money," said NICE chief executive Sir Andrew Dillon. "Our independent advisory committees specifically look for innovation i...
  • GSK's Witty: UK Delaying New Cancer Drugs Due to Cost

    Andrew Witty, the chief executive of pharmaceutical manufacturer GlakoSmithKline, said in an interview with the BBC on 25 February he believes the UK's National Institute for Health and Clinical Excellence (NICE) is purposefully delaying new drugs in order to save the government money . It's bad enough that reimbursement amounts are being systematically reduced across Europe, said Witty, "[but] governments are now delaying the approval of innovative new drugs." Witty...