News Wire

The FDA has approved emicizumab-kxwh (Hemlibra, Genentech) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors––the first new medication for these patients in nearly 20 years. Nearly one in three people…
The FDA has approved the first treatment for children and adults with mucopolysaccharidosis type VII (MPS VII), an extremely rare, progressive condition that affects most tissues and organs. Vestronidase alfa-vjbk (Mepsevii, Ultragenyx Pharmaceutical, Inc.) treats an inherited metabolic condition also…
In its quest for new ways to address the opioid epidemic, the FDA has cleared an existing electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for…
As a growing number of cancer treatments focus on specific genetic mutations, the FDA has authorized a next-generation sequencing (NGS) test than can rapidly identify genetic biomarkers in 468 genes––more than any test previously reviewed by the agency. IMPACT (Integrated Mutation Profiling of Actionable…
Five people have died of sepsis in late-phase trials of the Parkinson’s disease medication tozadenant (Acorda Therapeutics, Inc.), leading the company to monitor patients more closely, suspend enrollment in long-term safety studies, and discuss next steps with the FDA and the trials’ independent…
Benralizumab (Fasenra, AstraZeneca/MedImmune) has secured  FDA approval for the add-on maintenance treatment of patients with severe asthma 12 years of age and older with an eosinophilic phenotype. The FDA approval is based on results from the WINDWARD program, including the pivotal phase 3 exacerbation…
Add another regret to my list. A few years ago I interviewed Uwe Reinhardt for this magazine. Our conversation was placed on our website here. It hints, but only hints, at the measure of the man: his brilliance, kindness, humor, and zest for life. After the filming, he and I and the cameraman talked…
Janssen Biotech, Inc., a unit of health care conglomerate Johnson & Johnson, has dropped a lawsuit it filed to block a copy of its rheumatoid arthritis drug infliximab (Remicade) produced by South Korea’s Samsung Bioepis Co. Ltd. from being sold in the United States. Janssen, in a document to the…
A new analysis from the CANVAS program has shown that canagliflozin (Invokana, Janssen) demonstrated a reduced risk of cardiovascular (CV) outcomes in patients with and without a history of CV disease. The drug also achieved similar and proportional risk reductions for hospitalization due to heart failure…
High blood pressure should be treated earlier with lifestyle changes and in some patients with medication—at 130/80 mm Hg rather than 140/90—according to the first comprehensive new high blood pressure guidelines in more than a decade. The guidelines are being published by the American Heart Association…
The FDA has approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor, Otsuka Pharmaceutical Co., Ltd.) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment…
The FDA has approved aprepitant injectable emulsion (Cinvanti, Heron Therapeutics, Inc.) for intravenous (IV) infusion for treating acute and delayed chemotherapy-induced nausea and vomiting (CINV). The agent, a substance P/neurokinin-1 (NK1) receptor antagonist, is indicated in adults, in combination…
The FDA has expanded the indication for dasatinib tablets (Sprycel, Bristol-Myers Squibb Company) to include the treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. Approval was based on data from 97 pediatric patients with chronic phase CML evaluated…
Cariprazine (Vraylar, Allergan PLC) has received FDA approval for the maintenance treatment of adults with schizophrenia. Cariprazine was previously approved for adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. "Schizophrenia is one…
Testing of C-reactive protein (CRP) may offer a quick and reliable way to identify the patients most likely to achieve the greatest benefits from long-term treatment with canakinumab (Novartis), according to a new analysis of the phase 3 CANTOS study. The results, presented by Dr. Paul Ridker, MD, at…

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