• Regulatory NewsRegulatory News

    Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar

    For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s blockbuster Enbrel (etanercept). Wednesday’s vote – 20-0, with no abstentions – comes on the heels of Tuesday’s 26-0 vote i n favor of approving Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab) . The discussion of Sandoz’s biosimilar was also less focuse...
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    FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster

    Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.” “In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences i...
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    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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    Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants

    The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate. The tours and program are part of efforts by CDER to train and develop its regulatory project management staff to further enhance review efficiency and quality by providing the staffers with a better understanding ...
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    EU High Court Upholds Orphan Exclusivity Ruling

    Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe. In its appeal, Teva contested the ruling of a lower court that found orphan product exclusivity covers all indications a product is approved for. Background In 2001, Novartis won marketing authorization for its orphan product Glivec (imatinib), marketed as Gleevec in the US, as a first-line t...
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    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
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    India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment

    India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss. The notice comes just two days after officials in two Indian states put sales of the cancer drug on hold after injections of the drug damaged the vision of 15 patients in the western state of Gujarat. According to Reuters, ...
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    After Being Sued for Patent Infringement, Cipla Offers to License Novartis Drug

    In the midst of arguments before a prominent court in India, generic drug maker Cipla has offered to pay a "reasonable" royalty to Swiss multinational Novartis, The Economic Times reports. The case will test a number of issues, including how licensing arrangements could work out when a company has already launched a generic version of a patented medicine and India's stance on the controversial practice of compulsory license. Intellectual Property: Background Novartis...
  • NICE: Novartis' Jakavi not Cost-Effective for Treating Myelofibrosis

    In final draft guidance released today, the UK's National Institute for Health and Care Excellence (NICE) has recommended against the use of ruxolitinib (Jakavi, Novartis) for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis, or post essential thrombocythaemia myelofibrosisi. Myelofibrosis is a rare blood cancer in which the bone marrow produces too many cells too...
  • Novartis Hammered by US Attorneys for Second Time in Four Days as Further Allegations Emerge

    The US subsidiary of pharmaceutical manufacturing giant Novartis has been hit with a lawsuit filed by the federal government, the second in just four days as US attorneys hone in on the company for a string of alleged infractions that now include paying kickbacks to individuals and companies in return for prescribing the company's medication in place of others'. Background Novartis' week was already off to a bad start, having been accused by the US government of condu...
  • Novartis' and Forrest's Cystic Fibrosis Drugs Green Lighted by NICE

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has recommended  reimbursement for tobramycin (Tobi Podhaler, Novartis) and colistimethate sodium (Colobreathe, Forest Laboratories UK) dry powders for inhalation (DPI) as options for treating lung infections in patients with cystic fibrosis.   The recommendation for each drug is limited to clearly defined circumstances. Novartis' tobramycin DPI is recommended ...
  • NICE Gives Thumbs Down to Novartis Breast Cancer Drug

    In draft guidance released on 20 March 2013, the UK's National Institute for Health and Clinical Excellence (NICE) recommends against National Health Service (NHS) reimbursement for Novartis' breast cancer drug Afinitor (everolimus) despite its life extending benefits. Novartis submitted clinical trial data that established that the median progression-free survival benefit (the time point in the trial at which the 50% of people experience either disease progression or d...