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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,…

Career Opportunities

HAP, a subsidiary of Henry Ford Health System, is a nonprofit health plan providing coverage to individuals, companies and organizations. This executive develops strategies to meet membership and revenue targets through products, pricing, market segmentation and advertising.  Aligns business among Business Development, Commercial Sales, Medicare and Public Sector Programs and Product Development. Seeks to enhance and be responsible for business development and expansion through the development of an effective product portfolio, strong interpersonal relationships and service excellence.

Apply via email to jfedder1@hfhs.org or online at http://p.rfer.us/HENRYFORDlXqAJA

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…