News Wire

The FDA has accepted a supplemental biologics license application that seeks to expand the use of nivolumab (Opdivo, Bristol-Myers Squibb) to include patients with classical Hodgkin’s lymphoma (cHL) after prior therapies. The application included data from the CheckMate-205 trial, which evaluated…
In response to concerns about incomplete and misleading data, 60 senators have sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting that the agency delay releasing overall star ratings for hospital quality on April 21. In their letter to acting CMS administrator Andy Slavitt,…
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 12 to 1 in favor of requiring Clovis Oncology to finish its pivotal phase 3 study of rociletinib before the agency considers whether to approve the drug for marketing. Most of the panelists concluded that it was too early to confirm the…
A global head-to-head phase 2b study has compared afatinib (Gilotrif, Boehringer Ingelheim) and gefitinib (Iressa, AstraZeneca) in patients with non–small-cell lung cancer (NSCLC) whose tumors harbored the most common epidermal growth factor receptor (EGFR) mutations. The results, published in Lancet…
The FDA has announced that the new drug application for Remoxy (Durect Corporation/Pain Therapeutics), an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review. September 25, 2016, is the target action date under the Prescription…
Clemastine fumarate, a common antihistamine used to treat symptoms of allergies and the common cold, partially reversed damage to the visual system in people with multiple sclerosis (MS) in a preliminary study presented at the American Academy of Neurology’s 68th annual meeting in Vancouver, Canada.…
Proposed changes in Medicare payments for physician-administered drugs would reduce reimbursements for treatments that cost more than $480 per day starting in the fall of 2016, according to a new analysis from Avalere Health. As a result, specialists who use higher-priced drugs, including oncologists,…
At a White House briefing, Dr. Anne Schuchat, a deputy director of the Centers for Disease Control and Prevention, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, expressed concern about the threat the Zika virus poses to the United States. They said that…
The FDA has approved venetoclax (Venclexta, AbbVie/Genentech) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venetoclax is the first FDA-approved treatment that targets…
The U.S. Preventive Services Task Force (USPSTF) has released a final recommendation statement on the use of aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer. Evidence shows that low-dose aspirin use is most beneficial for adults 50 to 59 years of age, according…
The FDA has approved BioMonitor 2 (Biotronik), an insertable cardiac remote monitor designed to provide physicians with the ability to detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who…
A new plant-derived drug could be a step forward in preventing and treating multiple sclerosis (MS) and other autoimmune diseases, according to Dr. Christian Gruber, a researcher at the University of Queensland in Australia. “This is a really exciting discovery because it may offer a whole new quality…
The FDA has accepted a biologics license application (BLA) and granted a priority review designation for atezolizumab (Genentech) for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) whose disease expresses programmed death ligand-1 (PD-L1) proteins,…
A newly discovered antibiotic-resistant gene is threatening to open a new front in the war against “superbugs” by rendering a last-resort drug ineffective, experts warn. Dubbed mcr-1, the resistance-conferring gene easily transfers among bacteria found in humans, animals, or the environment. The…
The medical marketplace is about to get bigger. The FDA cleared a second biosimilar product—Inflectra (infliximab-dyyb, Janssen Biotech), a biosimilar to Remicade (infliximab, Janssen)—on April 5 and expects to approve other biosimilars in the future. The agency gave the nod to Zarxio (filgrastim-sndz,…

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