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.
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.
Both Summit Therapeutics plc and Insmed Inc. have taken wiping out bacteria to the next level, releasing separate clinical trial data last week that show their drugs target specific bacteria and reach hard-to-treat places in the lung that bacteria hide, respectively.