News Wire

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 authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients. Specifically, the FDA permitted marketing for a new use of the BRUKER MALDI Biotyper CA system (Bruker Daltonik GmbH) for the identification of C. auris,…
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…
The FDA has approved fostamatinib disodium hexahydrate (Tavalisse, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen tyrosine kinase…
The FDA has approved osimertinib (Tagrisso, AstraZeneca) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.…
The largest U.S. manager of prescription benefits is telling drug-makers that the current pricing model is broken and is taking aim at Amgen and other makers of new migraine medicines to try and fix it, according to a Reuters report. Express Scripts told Reuters it is pressing them to forego the usual…
The FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate- or poor-risk, previously untreated advanced renal cell carcinoma (RCC). The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label…
The FDA has provided full approval for idarucizumab (Praxbind, Boehringer Ingelheim), the specific reversal agent for dabigatran (Pradaxa, Boehringer Ingelheim). Idarucizumab is indicated for patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency…
The FDA has permitted marketing of IDx-DR (IDx LLC)—the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood…
The cost of new anticancer drugs increased more than fivefold from 2006 to 2015, but a new analysis suggests that cancer patients and insurers may be getting less for their money, according to a Reuters report. Anticancer medications account for the lion’s share of global drug spending, and the average…
The FDA has cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology (Johnson & Johnson Vision Care, Inc.) are soft contact lenses indicated for daily use…
The FDA has approved rucaparib (Rubraca, Clovis Oncology, Inc.) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The agency granted regular approval…
The FDA has issued an order to restrict the sale and distribution of the Essure permanent contraception device (Bayer) to ensure that all women considering use of the device are provided with adequate risk information so that they can make informed decisions. The agency is taking this step after becoming…
Alzheimer’s researchers have proposed a radical change in the way the disease is defined, focusing on biological changes in the body rather than clinical symptoms such as memory loss and cognitive decline, according to a Reuters report. The new research framework, released by the Alzheimer’s Association…
Positive first-time results have been published for Duobrii (halobetasol propionate and tazarotene lotion, Ortho Dermatologics) for the treatment of plaque psoriasis. The data appear in the Journal of the American Academy of Dermatology. Two phase 3, multicenter, randomized, double-blind clinical trials…

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