Report: Ranbaxy may sell generic Lipitor rights if unable to get FDA approval
NEW YORK — While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can’t win Food and Drug Administration approval in time, according to published reports.
Citing Credit Suisse analysts, Bloomberg reported that the FDA may delay approval of Ranbaxy’s version of Lipitor (atorvastatin), which would prevent it from marketing the drug starting Nov. 30, as it has planned to do.
Still, according to Bloomberg, the company — mostly owned by Japan’s Daiichi Sankyo — is in discussions with the FDA.
Lipitor is the world’s top-selling drug, with more than $7 billion in sales in the United States, according to IMS Health data.
Sandoz sues Novo Nordisk over diabetes drug
NEW YORK — Generic drug maker Sandoz is suing Danish drug maker Novo Nordisk over a generic version of a drug used to treat diabetes, according to published reports.
Bloomberg reported that Sandoz, the generics arm of Swiss drug maker Novartis, was suing Novo Nordisk in a Detroit federal court, hoping the court would find that the Sandoz generic version of Novo Nordisk’s Prandin (repaglinide) did not infringe on the latter company’s patent covering the drug.
Sandoz is hoping to bring the drug to market before the drug loses patent protection, according to Bloomberg. The patent is scheduled to expire in June 2018, according to Food and Drug Administration records.
Breast cancer drug may cause heart health problems among those with history of heart disease, diabetes
NEW YORK — A new study published in the Annals of Oncology found that a certain breast cancer drug may pose an increased risk of heart problems in elderly patients with a history of heart disease and/or diabetes.
After examining the records of 45 women between the ages of 70 and 92 years that have been treated with trastuzumab since 2005, 12 of the patients (26.7%) developed heart problems. Additionally, 33% of the women with a history of heart disease developed either asymptomatic and symptomatic heart problems as a result of taking trastuzumab, compared with only 9.1% of women without such a history, and 33.3% of women with diabetes developed problems, compared with only 6.1% without the condition. When trastuzumab treatment was stopped, all but one of the women fully recovered, while five of them were able to restart the treatment.
Study author César Serrano, who conducted the research while working as a clinical fellow at the Department of Medical Oncology Breast Cancer Centre at the Vall d’Hebron University Hospital in Barcelona, said that "this is the first study specifically to assess trastuzumab-related cardiac toxicity and the cardiovascular factors that are associated with an increased risk in a selected population of elderly breast cancer patients."
Serrano, who now is a postdoctoral research fellow at Brigham and Women’s Hospital in Boston, said that based on the results, "[we] think that it is reasonable to refer elderly breast cancer patients to a cardiologist if one or more cardiovascular risk factors are present before or during treatment with trastuzumab. Moreover, a closer surveillance of early symptoms and cardiac function is highly recommended."