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Duobrii Produces Positive Phase 3 Results in Psoriasis Treatment

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…

Keytruda Scores Another Win in Phase 3 Lung Cancer Study

The pivotal, phase 3 KEYNOTE-042 trial evaluating pembrolizumab (Keytruda), Merck’s anti-programmed death-1 (PD-1) therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary…

FDA Restricts Sale and Distribution of Essure Contraception Device

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…

Researchers Propose New Alzheimer’s Definition Based on Biology

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…

FDA OKs Second Ovarian Cancer Indication for PARP Inhibitor Rubraca

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…

FDA Approves Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

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…

Briefly Noted April 2018

The window of time between a stroke and effective thrombectomy may be as long as 16 hours in many cases, according to a study in the New England Journal of Medicine. But advanced brain imaging technology may give physicians an extra 10 hours or more to respond to treat some strokes. A study published…

Pradaxa Reversal Agent Praxbind Receives Full FDA Approval

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…

FDA Clears First Contact Lens With Light-Adaptive Technology

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…

Managed care rules in Medicaid

Thirty-nine states had contracts with comprehensive risk-based Medicaid managed care organizations and in 29 of those states, 75% or more of the Medicaid beneficiaries were enrolled in one of those organizations. A large majority (27 of 32) of the Medicaid expansion states used managed care organizations to cover newly eligibly adults.

FDA Approves Opdivo Plus Yervoy Combination for Certain Renal Cell Carcinoma

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…

Study: As Cancer Drug Prices Climb, Value Not Keeping Pace

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…

Express Scripts Targets New Migraine Drugs to Change U.S. Pricing Dynamic

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…

Tagrisso Upgraded to First-Line Treatment for Certain Lung Cancer

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.…

FDA Approves First Therapy for Rare Inherited Form of Rickets

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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