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    India Fines GSK, Sanofi for Alleged Anti-Competitive Practices

    The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...
  • FDA Warning Letter Hits GSK for Contaminated API, Reproducibility Challenges

    A new Warning Letter sent to GlaxoSmithKline CEO Andrew Witty chides the company for alleged manufacturing deficiencies found by US Food and Drug Administration (FDA) inspectors at the company's manufacturing subsidiary in Cork, Ireland. That subsidiary, SmithKline Beecham (Cork) Ltd., is a manufacturer of active pharmaceutical ingredients (API) for GSK. During an October 2013 inspection, FDA said its inspectors found at least three major problems that caused the facilit...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • GSK Warns Some of its OTC Weight Loss Drug Has Been 'Tampered With'

    Pharmaceutical manufacturer GlaxoSmithKline is warning consumers that some bottles of its over-the-counter weight loss drug Alli (orlistat capsules) have "tampered with" in at least seven US states. News of the tampering was announced by GSK in a 26 March 2014 press release, in which the company said it was working with the US Food and Drug Administration (FDA) to determine what had happened and the extent of the problem. GSK said the tampered products had packaging tha...
  • GSK Bets Big on Bioelectronic Medicine as Regulatory Questions Loom on Horizon

    • 08 August 2013
    Back in April 2013, Focus covered a rather futuristic-sounding announcement from GlaxoSmithKline regarding its funding of a new field of medicine the company was calling "electroceuticals"-more formally known as bioelectronic medicine-an emerging field of medicine that might one day use the body's own electronic signals to treat patients. While the initial funding was small-just $1 million, a miniscule fraction of GSK's $40 billion in annual revenue last year-the compan...
  • In Reversal, NICE Gives GSK’s Revolade Thumbs-up for Bleeding Disorder

    The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), issued final guidance on 24 July 2013 recommending reimbursement for GSK's Revolade (eltrombopag). NICE's recommendation covers its indication as an option for treating patients with the bleeding disorder chronic immune (idiopathic) thrombocytopenic purpura who have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies.  The positi...
  • NICE Opens Second Consultation on GSK's Belimumab for Lupus

    The UK's National Institute for Health and Care Excellence (NICE) has released new draft guidance recommending against the National Health Service's (NHS) use of GlaxoSmithKline's Benlysta (belimumab) within its licensed indication as an add-on therapy in adults with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity despite standard therapy. Systemic lupus erythematosus (SLE) is an incurable autoimmune condition mainly af...
  • GSK's Less Effective, Less Costly Bleeding Disorder Treatment Wins NICE Backing

    The National Institute for Health and Care Excellence (NICE) yesterday issued final draft  guidance recommending reimbursement for GlaxoSmithKline's Revolade (eltrombopag) for chronic immune (idiopathic) thrombocytopenic purpura (ITP), a bleeding disorder, even though the drug is less effective than Amgen's Nplate (romiplostim), which NICE recommended in 2011. In guidance released on 12 June 2013, NICE agreed that eltrombopag was less effective but also less costly...
  • GSK's new COPD Therapy Wins FDA Approval

    The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's chronic obstructive pulmonary disorder (COPD) drug Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), just weeks after an FDA advisory council gave the drug its stamp of approval. The drug is a combination of the inhaled corticosteroid fluticasone furoate and a long-acting bronchodilator, vilanterol. In a statement, FDA said the drug, which had undergone clinical testing in nearl...
  • GSK Investigated for 'Pay-for-Delay' Agreements in UK

    • 19 April 2013
    So-called "pay-for-delay" deals are nothing new for US pharmaceutical companies, where the practice of exchanging a payment in return for a set date of market entry (arguably later, hence the "delay") has seen increased use in recent years. Regulators, however, have never been particularly comfortable with the idea, saying the deals are anti-competitive and thus illegal under federal law. Now that idea is spreading, with UK trade regulators accusing several companies, mo...
  • GSK Announces Grant Program to Support 'Electroceuticals,' Raising Regulatory Questions

    • 11 April 2013
    Could "electroceuticals" be the newest healthcare product category worth watching? UK life sciences manufacturer GlaxoSmithKline thinks it is, and is putting up money to what it deems is quite literally "the million-dollar question":  What promises might this new field of medicine hold? What Are Electroceuticals? In relative terms, a million-dollar bet isn't much considering the almost $40 billion in revenue GSK made in 2012, but it is a step in the right directi...
  • PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance

    Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance published by US regulators, saying minor changes are needed to reflect the clarity of the guidance and its lifespan. Background Their comments reference a 3 January 2013 draft revision of guidance for industry that would require all new drug applications (NDAs), abbreviate...