Immuno-oncology drugs Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) came in first and third in the latest edition of the Trinity Drug Index, with hepatitis C drug Harvoni (sofosbuvir/ledipasvir, Gilead Sciences Inc.) taking the second spot. This version of the annual index scores the 41 drugs approved by the FDA in 2014 based on commercial, therapeutic and R&D categories.
Immuno-oncology drugs Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) came in first and third in the latest edition of the Trinity Drug Index, with hepatitis C drug Harvoni (sofosbuvir/ledipasvir, Gilead Sciences Inc.) taking the second spot. This version of the annual index scores the 41 drugs approved by the FDA in 2014 based on commercial, therapeutic and R&D categories.
The old saying "many hands make quick work" doesn't apply to drug manufacturing for use in clinical trials, according to a new study from The Tufts Center for the Study of Drug Development (CSDD) looking at single-source vs. multivendor manufacturing at contract development and manufacturing organizations (CDMOs).
With a third of the world's cancer patients residing in China and upward of half of them enrolling in clinical trials, small U.S.-based companies are looking across the Pacific to test their oncology drug candidates.
The use of artificial intelligence (AI) in drug development has increased substantially over the last few years. And both large pharmaceutical companies and venture capital are starting to take notice.
The use of artificial intelligence (AI) in drug development has increased substantially over the last few years. And both large pharmaceutical companies and venture capital are starting to take notice.
T-cell checkpoint inhibitors, such as drugs targeting PD-1/PD-L1 and CTLA-4, have been successful at helping the immune system attack certain tumors, but the drugs fail to spur a response in many tumor types. Palleon Pharmaceuticals Inc. is taking a different approach, developing drugs to inhibit glycoimmune checkpoints that allow tumors to evade the innate immune system – dendritic cells, macrophages and NK cells – as well as T cells.
It's been a rough couple of weeks for Intercept Pharmaceuticals Inc. In the middle of September, Intercept issued a Dear Healthcare Provider letter stressing the importance of proper dosing of its primary biliary cholangitis (PBC) treatment, Ocaliva (obeticholic acid), in patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis) who are supposed to take 5 mg of Ocaliva once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. Instead, some doctors were giving the dose for patients with no or mild hepatic impairment (noncirrhotic or Child-Pugh A cirrhosis), which starts at 5 mg once daily – seven times the dose for patients with moderate or severe hepatic impairment.
It's a double whammy for cardiovascular drug developers, according to a new study from the Tufts Center for the Study of Drug Development. It's taking longer to get a cardiovascular drug through the clinic and onto market. And more drugs are failing along the way.
