News Wire

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 of life for people with this debilitating disease,” he said.

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, as determined by an FDA-approved test, and who have progressed on or after platinum-containing che

The FDA’s Gastrointestinal Drugs Advisory Committee has voted unanimously (17 to 0) to recommend accelerated approval of Ocaliva (obeticholic acid, Intercept Pharmaceuticals) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act is May 29, 2016.

Staff reviewers at the FDA have questioned whether the lung cancer treatment rociletinib (Clovis Oncology) is more effective than available treatments. The reviewers also recommended including a boxed warning in the drug’s label, if it is approved.

An FDA safety review has found that type-2 diabetes medications containing saxagliptin or alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.

A new screening approach developed by Kaiser Permanente has been shown to close gaps in diagnosis and care for patients with hepatitis C virus (HCV) infection, according to new research published in Clinical Infectious Diseases.

A new data analysis has shown that levels of eosinophils can help identify patients with chronic obstructive pulmonary disease (COPD) who may or may not benefit from the addition of inhaled corticosteroid (ICS) treatment. The post hoc analysis was published online in Lancet Respiratory Medicine.

The Institute for Clinical and Economic Review (ICER), a nonprofit organization whose members include drug makers and insurers, has scheduled a meeting next month to review the value of multiple myeloma treatments and to determine a benchmark for payers. The meeting comes as concerns grow over the costs of these drugs, which range from $8,000 to $14,000 a month.

The FDA has approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System (Medtronic) works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.

One of the tools designed to be a “fix” for medical errors isn’t working as well as it should, according to a report from the Leapfrog Group, a nonprofit organization known for rating hospitals on patient safety.

Enrollment has begun in the first of two multinational clinical trials of an intravenously delivered investigational antibody for preventing human immunodeficiency virus (HIV) infection.

Researchers at the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital in Boston have designed a new type of pill that, once swallowed, can attach to the lining of the gastrointestinal (GI) tract and slowly release its contents.

An article published in the journal BioMetals has raised questions about the safety of the gadolinium-based contrast agents that are used in approximately 30% of magnetic resonance imaging (MRI) scans. Researchers in Israel analyzed studies detailing the known and proposed mechanisms of retained gadolinium toxicity.

Zika investigators now believe that microcephaly in newborns and Guillain–Barré syndrome in adults may be just the most obvious disorders caused by the mosquito-borne virus, according to a report from Reuters. Fueling that suspicion are recent discoveries of serious brain and spinal cord infections, including encephalitis, meningitis, and myelitis, in people with Zika virus infection.

The FDA has approved infliximab-dyyb (Inflectra, Celltrion, Inc.) for multiple indications. The product is biosimilar to infliximab (Remicade, Janssen Biotech), which was originally licensed in 1998. This is the second time the FDA has cleared a biosimilar product.

Infliximab-dyyb is indicated for the treatment of: