News Wire

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,…
Days after President Donald Trump delivered a speech on prescription drug prices that was notably light on criticism of the pharmaceutical industry, his health secretary on Monday struck a far more aggressive tone, warning that the administration would be “turning on the pressure” on drug makers,…
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…
The FDA has approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution, Salix Pharmaceuticals, Ltd.), a lower-volume (1-L) polyethylene-glycol–based bowel preparation. Colorectal cancer is the third leading…
Flushing the bladder with gemcitabine—a common chemotherapy drug—immediately after surgery significantly reduces the chances of bladder cancer returning, according to a major study led by Edward M. Messing, MD, and an international clinical trials network (SWOG) funded by the National Cancer Institute…
Frustrated by tepid sales and practical stumbling blocks, Regeneron and Sanofi are offering a huge discount on their treatment for bad cholesterol in exchange for a promise that health care’s biggest middleman will make it easier for patients to actually get the drug, according to a STAT report. Starting…
The FDA has cleared the emergency use of PLX-R18 (Pluristem Therapeutics), a placenta-based stem cell therapy, to treat acute radiation exposure in a nuclear event. Pluristem said it will start preparations to keep an emergency stock of PLX-R18 on hand for use in such events, Reuters reports. Full approval…
The FDA has granted both qualified infectious disease product (QIDP) and fast-track designations for the oral formulation of SCY-078 (SCYNEXIS, Inc.), a novel antifungal agent, for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC. In addition, the company announced…
The FDA has approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist), both Novartis products, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. The…
The FDA has approved tolvaptan (Jynarque, Otsuka Pharmaceutical Co., Ltd.) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disease with consequences that can lead to dialysis…
Many think that a marriage between the tech and health sectors would be a match made in heaven, but so far here on plain old planet Earth, it’s been at most a flirtation.  But big tech is doing some health care hiring, so perhaps something real is starting to happen.  Stat reported recently…
The FDA has approved burosumab-twza (Crysvita, Ultragenyx Pharmaceutical), the first drug approved to treat adults and children 1 year of age and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone…

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