• Italian Regulators Affirm Safety of Novartis' Vaccines

    • 12 November 2012
    Italy's Agenxia Italiana del Farmaco (AIFA) has joined Canadian and Swiss regulators in affirming the safety of Novartis' Agrippal (alternately known as Agriflu) and Fluad after concerns were raised about the safety effects of a protein aggregation within vials of the vaccine. The concerns were first brought to regulators' attention in late October 2012, leading several regulatory agencies-including those of Italy, Spain, Switzerland, Canada, Germany and France-to susp...
  • Novartis Vaccine Cleared by Canadian, Swiss Regulators after Quality Concerns

    • 05 November 2012
    Regulators with Health Canada and Switzerland's Swissmedic are lifting their respective bans on Novartis' trivalent flu vaccines Agrippal and Fluad after independent testing found them to be safe for human use. The vaccines had been suspended by the regulators of no fewer than five countries-Italy, Canada, Germany, Switzerland and Spain-after Novartis raised concerns with them regarding the presence of an unknown particulate aggregation , thought to be protein-based and...
  • Three More Regulators Move to Ban Sale of Novartis Vaccine

    • 29 October 2012
    Three more regulatory agencies have called for the recall and cessation of sales of two influenza vaccines manufactured by Novartis after the company reported finding particulate matter during its manufacturing process. The Italian Pharmaceutical Agency, AIFA, announced on 25 October it has banned the use and sale of Agrippal and Fluad, trivalent influenza vaccines, after it said it had become aware of the "presence of a protein aggregation phenomenon observed in the...
  • Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

    • 26 October 2012
    Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects. The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenome...
  • Novartis Cystic Fibrosis Drug Cleared for NHS Use

    The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has issued a draft guidance recommending the use of Novartis' Tobi Podhaler, an inhaled tobramycin dry powder intended for the treatment of pseudomonas lung infections in persons with cystic fibrosis. NICE's recommendation comes as Forest Laboratories' competing drug Colobreathe (colistimethate sodium dry powder for inhalation) was not recommended for use by NICE because ...
  • Sandoz Issues Recall After Packaging Errors Found

    Novartis AG subsidiary Sandoz announced on Wednesday, 6 June the initiation of a recall for ten lots of its oral contraceptive Intravole (levonorgestrel) after consumers notified the company of a packaging mix-up. Sandoz said the packaging error resulted in pills containing placebos being placed incorrectly within the blister packs, opening the possibility of consumers taking the oral contraceptives at the incorrect time. The blister packs ordinarily contain the placebo ...
  • FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

    The US Food and Drug Administration (FDA) has placed new contraindications on Novartis' Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon after taking the drug. FDA said it had completed an investigation into the adverse event reports, and while it "could not definitely conclude that Gilenya was related to any of the deaths," it remained "concerned about the cardiovascular effects of Gilenya after the first dose....
  • 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...
  • Massive Genome, Cancer Databases Made Public

    • 30 March 2012
    The National Institutes of Health (NIH) and a consortium of cancer research groups both announced this week they are releasing their respective databases-NIH's 1000 Genomes Project and the group's Cancer Cell Line Encyclopedia (CCLE) project-to the public. The moves open the world's largest set of human genetic variation and more than 1,000 cancer cell lines to public and industry use. NIH's announcement on 29 March said its 200-terabyte 1000 Genomes Project would be mad...
  • India's Pharmaceutical Industry Prepare for Pivotal Court Hearing on Drug Patents

    The Indian Supreme Court is set to hear a pivotal challenge to its patent system by Swiss pharmaceutical manufacturer Novartis, which is seeking to force the Indian government to recognize its patent on cancer drug Gleevec, reports the New York Times . Novartis contends that India improperly denied its patent for Gleevec-and, by proxy, those of many other drugs manufactured by western pharmaceutical companies-and filed suit six years ago to challenge the patent's status...
  • Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

    Swiss pharmaceutical company Novartis Consumer Health Inc. recalled four products yesterday, citing quality concerns that could expose consumers to " foreign tablets, caplets, or capsules ," as well as broken and chipped pills. The product recall affects four popular Novartis-made drugs: Excedrin, NoDoz, Bufferin and GasX. The US Food and Drug Administration's (FDA) statement noted that consumers could be exposed to dangerous doses, unintended ingredients, allergic reac...