The FDA has approved a new type of antiretroviral medication for adults living with human immunodeficiency virus (HIV) who have tried multiple medications that are no longer controlling their disease. Ibalizumab-uiyk (Trogarzo, TaiMed Biologics USA Corp.) is indicated for heavily treatment-experienced…
A new noninvasive stereotactic radiotherapy system (GammaPod, Xcision Medical Systems, LLC) intended for use in treating cancer in breast tissue has received FDA approval. “… Patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast…
Novartis’s Sandoz division has won FDA approval for a larger dosage of glatiramer acetate injection (Glatopa) for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market, according to a Reuters report. The FDA approved a 40-mg/mL injection of…
A new treatment for the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) that would cut the number of infusions needed each year by three-quarters fared well in a pivotal phase 3 study, the developer announced. ALXN1210 (Alexion Pharmaceuticals, Inc.), an investigational long-acting C5…
Updated results from a global clinical trial of the CAR T-cell therapy tisagenlecleucel (Kymriah, Novartis) show that children and young adults continued to show high rates of durable, complete remission of their high-risk form of acute lymphoblastic leukemia (ALL), according to a study published in…
A final analysis of the phase 3 ASPIRE trial showed that adding carfilzomib (Kyprolis, Amgen) to lenalidomide and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma, Amgen announced. The analysis, published…
The FDA has approved Giapreza (angiotensin II injection, La Jolla Pharmaceutical Co.) for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. "Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death," said Norman…
A vast research study that sought to settle a long-standing debate about whether or not antidepressant drugs really work has found they are indeed effective in relieving acute depression in adults, according to a Reuters report. The international study––a meta-analysis pooling results of 522 trials…
The new year has again coincided with a hike in U.S. drug prices, with more than 30 drugs seeing an increase. However, after receiving continued criticism from both the public and politicians, the industry appears to be sticking within a 10% self-imposed price-hike limit, according to consultant GlobalData.…
The FDA has approved apalutamide (Erleada, Janssen Pharmaceutical Companies), the first treatment indicated for nonmetastatic, castration-resistant prostate cancer. “This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread…
President Donald Trump said prescription drug prices will come “rocketing down” under the leadership of the new secretary of Health and Social Services (HHS), according to a report from The Hill. “We have to get the prices of prescription drugs way down and unravel the tangled web of special interest…
Newly released phase 3 results have shown that lanadelumab, Shire plc’s experimental hereditary angioedema (HAE) drug, reduced monthly attack rates and improved quality of life compared with placebo. Recently presented at the 2018 American Academy of Allergy, Asthma, and Immunology meeting, the data…
As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information, says FDA Commissioner Scott Gottlieb, MD. The agency is especially focused on information that can improve patient care and better…
Of the 30 U.S. children who have died from the flu so far this season, some 85% had not been vaccinated, said Centers for Disease Control and Prevention Director Brenda Fitzgerald, MD, who urged Americans to get flu shots amid one of the most severe flu seasons in years. “My message is, if you haven’t…
The Advisory Committee on Immunization Practices (ACIP) has voted to restore the recommendation it withdrew two years ago for the use of an intranasal flu vaccine. The recommendation reflects positive results from a U.S. study in children between their second and fourth birthdays. AstraZeneca announced…
