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The FDA has approved an expanded indication for fingolimod (Gilenya, Novartis) to treat relapsing multiple sclerosis (MS) in children and adolescents 10 years of age and older. This is the first FDA approval of a drug to treat MS in pediatric patients. “For the first time, we have an FDA-approved…
The Department of Justice has joined whistleblower litigation accusing Insys Therapeutics, Inc., of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications, Reuters reports. The government’s involvement was disclosed in a filing made public earlier this…
The FDA has approved the use of daratumumab (Darzalex, Genmab) in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The supplemental biologics license application…
A new discovery shows that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain. However,…
A new discovery shows that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain. However,…
Kymriah (tisagenlecleucel), the landmark cell therapy Novartis brought to market last year, has gained a new indication that puts it in direct competition with Yescarta (axicabtagene ciloleucel), a rival treatment from Gilead Sciences, according to a recent BioPharma Dive article. Both therapies now…
The FDA has approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and is BRAF V600E mutation-positive. Both drugs are Novartis products.…
The FDA has permitted marketing of Hemospray (Wilson-Cook Medical, Inc.), a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. “The device provides an additional nonsurgical option for treating upper and lower GI bleeding in certain patients and may help…