Topic:

Clinical Trials

Latest Headlines

Latest Headlines

UPDATED: Merck's 'breakthrough' hep C combo plays catch-up with promising PhII results

Merck may be playing catch-up in the race to develop the first all-oral combo treatment for hepatitis C, but it made a good case over the weekend that it has a real contender in the pipeline.

Merck's next-gen HPV vaccine looks good in PhIII, but sales may disappoint

Merck believes it can win near-term approval for a new HPV vaccine that will do better than Gardasil in guarding women against the virus that causes cervical cancer. But the vaccine's estimated peak sales potential won't relieve the company's migraine over weakening drug sales.

Study: Drug developers routinely--and unethically--leave trial data in the dark

Drug companies routinely herald their concern for patients as the leading reason why they spend billions of dollars on drug research. But a new study questions Big Pharma's real commitment to its ethical obligations to patients when companies routinely neglect to publish the results of clinical trials.

Sanofi, Merrimack cancer drug flops (again) in second round of PhII program

Seven months after a mid-stage cancer drug from Sanofi and Merrimack Pharmaceuticals flunked its first mid-stage test, researchers are back with another failure to report. The Cambridge, MA-based biotech said that MM-121 (SAR256212), partnered with Sanofi in a $530 million deal, failed to hit the primary endpoint on progression free survival for ovarian cancer when combined with Taxol. Once again, though, the investigators are pointing to a subpopulation which benefited from the drug.

Pfizer bets big on PCSK9 with 'massive' Phase III outcomes study

Tantalized by various megablockbuster projections for the PCSK9 field of cholesterol drugs, Pfizer has mapped out one of the most ambitious late-stage programs in the industry for RN-316. 

Novum reaches into N. Dakota for clinical trials

CRO Novum has opened its latest hub for clinical trials, expanding into Fargo, ND, in an effort to grow the company's footprint and diversify its offerings.

SRI sets sights on CRO growth with Virginia expansion

Research outfit SRI International is bolstering its CRO division, spending millions to stretch its capabilities and lure more drug development clients to its Virginia labs.

UPDATED: Sanofi makes case for Fluzone superior clinical benefit label

In August, Sanofi gave a first look at eagerly anticipated data from Phase III comparing its high-dose Fluzone vaccine with a standard jab. The data prompted Sanofi to talk up its chances of getting a label for superior efficacy data in people aged over 65, and this week it began making its case.

UPDATED: Bristol-Myers adds promising survival update on breakthrough cancer drug

Bristol-Myers Squibb has added a few more brushstrokes to the very promising picture that's emerging from early-stage studies of nivolumab, a top PD-1 checkpoint receptor inhibitor billed as a major breakthrough in cancer drug research. 

Repros plummets as FDA questions testosterone drug data

Repros has again swung southward in its up-and-down development of the testosterone drug Androxal, pushing back its proposed NDA filing and revealing that the FDA is taking a hard look at its Phase III results, news that hammered its shares by about 30%.