Alirocumab injection (Praluent, Regeneron Pharmaceuticals/Sanofi) reduced the risk of major cardiac events by 15% among patients who had suffered heart attacks and other coronary events in the ODYSSEY OUTCOMES trial. The two companies have announced that they are willing to offer price breaks on the…
An independent analysis of pharmaceutical industry efforts to tackle drug resistance gives high marks to GlaxoSmithKline and Johnson & Johnson among the large research-based pharmaceutical companies, while Mylan leads the generic medicine manufacturers and Entasis leads in the biotechnology group. The…
In a late-stage study, a combination of experimental drugs—encorafenib and binimetinib (Array BioPharma, Inc.)—kept patients with advanced melanoma associated with a common gene mutation alive for nearly three years and twice as long as rival medicine vemurafenib (Zelboraf, Roche), according to…
GlaxoSmithKline (GSK) has won a further reprieve for its blockbuster lung drug Advair (fluticasone propionate and salmeterol inhalation powder) after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug, Reuters reports. The Jordan-based…
While e-cigarettes are not without health risks, they are likely to be far less harmful than conventional cigarettes, according to a congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. The committee that conducted the study concluded that e-cigarettes…
The FDA has approved a supplemental biologics license application updating the dosing schedule of nivolumab (Opdivo, Bristol-Myers Squibb) to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This approval will give health care professionals the flexibility to customize…
The FDA is adding a boxed warning to obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) in an effort to prevent incorrect dosing of the liver-disease medication in patients with moderate-to-severe primary biliary cholangitis (PBC). Obeticholic acid has been incorrectly dosed daily instead of…
The FDA has approved a combination of acetaminophen and the prodrug benzhydrocodone (Apadaz, KemPharm, Inc.) that the manufacturer believes is “a differentiated product for the short-term management of acute pain.” The FDA approved the immediate-release product for the short-term (no more than…
The FDA has approved tezacaftor/ivacaftor and ivacaftor (Symdeko, Vertex Pharmaceuticals, Inc.) to treat the underlying cause of cystic fibrosis (CF) in patients 12 years of age and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene…
Pembrolizumab (Keytruda, Merck) significantly improved recurrence-free survival compared with placebo in a phase 3 trial investigating the anti-PD-1 medication as monotherapy for surgically resected high-risk melanoma. Based on an interim analysis and following review by an Independent Data Monitoring…
Repeated vaccination for influenza in older adults reduced the severity of the virus and reduced hospital admissions, according to new research published in the Canadian Medical Association Journal. A team of Spanish researchers looked at the effect of repeated influenza vaccinations in the current…
Aetna, Inc., has announced that it will automatically pass on drug-maker rebates to about three million commercial members at the point of sale beginning in 2019, according to a BioPharma Dive report. The move comes less than a month after UnitedHealth Group, Inc., announced a similar initiative, which…
The flu or pneumonia claimed the lives of one out of every 10 Americans who died during the week ending February 3, according to the Centers for Disease Control and Prevention (CDC). Throughout most of the nation, the flu appears to remain on the rise, Acting CDC Director Anne Schuchat, MD, said at…
Solanezumab, a monoclonal antibody-based treatment for Alzheimer’s disease developed by Eli Lilly that targets amyloid plaques, did not significantly slow cognitive decline, according to a report published in The New England Journal of Medicine. Researchers have proposed that Alzheimer’s disease…
The FDA has approved the ranibizumab injection (Lucentis, Genentech) 0.3-mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and only FDA-approved medicine to treat all forms…
