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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…
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…
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…
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 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 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…

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