News Wire

The FDA has approved latanoprostene bunod ophthalmic solution, 0.024% (Vyzulta,  Bausch + Lomb) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Vyzulta, a once-daily monotherapy, is the first prostaglandin analog that has nitric oxide (NO)…
The drug approval process should include an only-in-research (OIR) step that would gauge real-world effectiveness. That’s the argument put forth by Anirban Basu, a professor at the University of Washington, in a Health Affairs blog post. Basu says that at the completion of phase II trials, the manufacturer…
A panel convened by President Donald Trump to tackle the opioid crisis has called for more treatment programs, tighter prescribing guidelines, and additional drug courts to help reduce overdose deaths, Reuters reports. The commission, led by New Jersey Governor Chris Christie, said the recommendations…
FDA advisory committees voted in a joint session to endorse two proposed products for the treatment of opioid problems: CAM2038 (Braeburn Pharmaceuticals, Inc.) and RBP-6000 (Indivior PLC). The agency is not obliged to follow the recommendations of its advisory committees, but it often does so. Braeburn…
Lackluster study results are leading global pharmaceutical giants to reconsider their development of interleukin (IL)-4 and IL-13 inhibitors in the treatment of lung ailments, Fierce Biotech reports. Sanofi disclosed that it has “decided to stop the development of SAR156597 in idiopathic pulmonary…
The FDA has granted accelerated approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology…
Opioid addicts saved by the overdose reversal medication naloxone are still in danger following their close brush with death, a new study shows. About 10% of overdose patients saved with naloxone (Narcan, Adapt Pharma, Inc.) in Massachusetts hospitals ended up dying within a year, Harvard researchers…
An independent nonprofit organization that evaluates the clinical and cost effectiveness of new medicines in the U.S. has received significant new funding that will enable it to greatly expand its work, the organization has announced.  The Boston-based Institute for Clinical and Economic Review (ICER)…
Forty-six state attorneys general taking part in a wide-ranging antitrust investigation of the generic drug industry are asking a federal court for permission to file a new complaint in the states’ pending lawsuit that increases the number of generic-drug manufacturer defendants from six to 18 and…
A phase 3 investigational study evaluating dupilumab (Dupixent, Sanofi and Regeneron Pharmaceuticals) in adults and adolescents with severe, steroid-dependent asthma has met its primary endpoint and key secondary endpoints. Dupilumab, a fully human monoclonal antibody, was approved by the FDA in March…
The FDA has approved the 10-mg once-daily dosing of rivaroxaban (Xarelto, Janssen) for reducing the continued risk for recurrent venous thromboembolism (VTE) after patients complete at least six months of initial anticoagulation therapy. This approval follows an FDA priority review and is based on data…
The FDA has granted orphan drug designation to MM-121 (seribantumab, Merrimack Pharmaceuticals, Inc.), an investigational drug candidate, for the treatment of heregulin positive non-small-cell lung cancer. MM-121 is a fully human monoclonal antibody designed to block tumor survival signals and enhance…
Full results from the positive phase 3 PARADIGMS study, investigating the safety and efficacy of fingolimod (Gilenya, Novartis), an oral disease-modifying therapy, versus interferon beta-1a in children and adolescents (ages 10–17 years) with multiple sclerosis (MS), have been announced. Treatment…
A phase 3 trial has demonstrated that, at the approved dose of 60 IU/kg, Haegarda (C1 esterase inhibitor subcutaneous [human]) reduced the median number of hereditary angioedema (HAE) attacks per month by 98% in patients who had frequent attacks, from a 16-week placebo period to a 16-week treatment…
The FDA has proposed a rule revoking the right of companies to say soy protein protects the heart, while potentially allowing a more circumspect health claim. The agency, which to date has never revoked a health claim, said studies published since it authorized the soy protein claim in 1999 had shown…

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