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In women with metastatic ovarian cancer restricted to the abdominal cavity (stage III), hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival with almost no additional side effects, according to research published in the New England Journal of Medicine. The research, led by the Netherlands…
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 U.S. Patent & Trademark Office (USPTO) has overturned the sole unexpired patent keeping generic competition at bay for the prostate-cancer medication abiraterone acetate (Zytiga, Janssen Oncology). Generic drug-maker Argentum Pharmaceuticals LLC successfully challenged all claims of a Janssen patent…
Cabozantinib (Cabometyx, Exelixis, Inc./Ipsen) improved overall and progression-free survival among previously treated liver cancer patients in the pivotal phase 3 CELESTIAL trial, according to results being presented at the 2018 ASCO-GI Symposium in San Francisco. At the planned second interim analysis…
Sick and tired of dealing with generic drug shortages and unpredictable price increases, five large U.S. health systems are taking an unusual step, Fierce Pharma reports: they're forming their own nonprofit generic drug-maker. Representing more than 450 hospitals, nonprofit groups Intermountain Healthcare,…
Early results from a key study have shown that a cocktail of Merck’s blockbuster drug pembrolizumab (Keytruda) and two chemotherapy agents helped lung cancer patients live longer and stopped the disease from advancing, according to a recent Reuters report. The results cement Merck’s position as…
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…
The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by…