Gilead Sciences halted six trials for its cancer drug Zydelig following concerns of adverse effects and deaths.

Researchers should be more cautious in dosing experimental medicines in early human trials, even when drugs are thought to be low risk, experts reviewing a French clinical study that left one person dead said on Wednesday.   The volunteer died and five others became seriously ill in January after being given high doses of a […]

Celator Pharmaceuticals Inc on Monday said its Vyxeos treatment helped older high-risk patients with a deadly form of leukemia live longer than those who received the standard of care regimen in a late stage clinical trial, sending its stock price soaring. Celator shares jumped to $9 in extended trading from a Nasdaq close at $1.68. […]

Vericel Corp.’s experimental drug reduced death, hospitalizations and emergency visits in patients who are at risk of a heart failure in a mid-stage study

Celldex Therapeutics Inc said it would discontinue a late-stage study of its brain cancer vaccine after an independent interim analysis suggested the therapy might not show a statistically significant benefit in patient survival compared with standard chemotherapy. Celldex shares more than halved to $3.76 in premarket trading on Monday. The vaccine, Rintega, belongs to an […]

Novo Nordisk said on Friday the results from a trial showed that its Victoza diabetes drug significantly reduced the risks of major adverse cardiovascular events.   “People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That’s why we are very excited about the results from LEADER (trial), which […]

Novo Nordisk and AstraZeneca, two drugmakers whose financial outlooks disappointed investors last month, are both hoping for a boost in the coming weeks from results of two closely watched clinical trials.   AstraZeneca wants to prove its blood-thinner Brilinta can help stroke patients, in addition to those with heart problems, while Novo aims to showcase the […]

In light of three failed clinical trials and disappointing financial statements, Durham, N.C.-based Chimerix (CMRX) cut about 20 percent of its workforce.   Chimerix focuses on the development of antiviral medications. At its recent fourth-quarter financial statements, the company reported a net loss of $117.4 million, or $2.67 per basic and diluted share for last […]

MUNICH, February 24, 2016 /PRNewswire/ — Recognizing the immediate need for access to new therapeutic options for multidrug-resistant TB (MDR-TB), Otsuka Novel Products GmbH (Otsuka) today announced an ambitious new public-private partnership with the Stop TB Partnership (Stop TB) to increase access and scale-up treatment of delamanid (Deltyba™) in low- and middle-income countries. Any country […]

  By Joseph Pierro, chief medical officer of Biomedical Systems.   In many clinical trials, clinical imaging plays an important role in the drug development process. Whether the trial involves drugs, biologics, or devices, imaging may be used to measure the efficacy and safety of the investigational product. An independent assessment based on the centralized […]