Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Galapagos' closely watched rheumatoid arthritis drug filgotinib scores in PhIIb

Belgium's Galapagos says that its oral JAK1 inhibitor filgotinib met its primary and other endpoints in a crucial Phase IIb study for rheumatoid arthritis.

Roche hustles its PD-L1 'breakthrough' star into 11 late-stage trials

In the checkpoint receptors race, Bristol-Myers Squibb is out in front with the biggest and fastest effort, a comeback Merck is in hot pursuit and Roche/Genentech and AstraZeneca are following but still in the front of the pack.

AstraZeneca's MedImmune gets RSV candidate fast-tracked

Two Maryland-based companies are racing to get a vaccine for respiratory syncytial virus to market--and one just picked up a regulatory boost.

One of Shire's top blockbuster drug prospects flops in a key PhII study

Two months ago Shire CEO Flemming Ornskov held up the rare liver disease drug SHP625 as a prime example of its most promising development programs. Today, though, Shire was forced to concede that the drug flopped against both the primary and secondary endpoints in the first of several Phase II studies.

Portola says it's ready to file 'breakthrough' anticoagulant antidote

Portola Pharmaceuticals has snapped in the last piece to a Phase III program puzzle for its "breakthrough" anti-anticoagulant, painting a clear path to an accelerated regulatory submission later in the year.

Ocular Therapeutix plunges as eye treatment blurs the line in PhIII

Ocular Therapeutix needed a clean sweep in its expansive Phase III program for a postoperative eye treatment in order to set itself up for a clear shot at an FDA approval. But it didn't get it.

Analysts: GSK shingles vaccine could steal market share from Merck's Zostavax

While GlaxoSmithKline is still awaiting late-stage results for its shingles vaccine, HZ/su, Cowen & Co. analysts believe the vaccine may just be better than Merck's Zostavax.

GlaxoSmithKline and Merck Ebola vaccines succeed in Phase II Liberian trials

Two Ebola vaccines, one developed by the NIH and GlaxoSmithKline and the other by Merck and NewLink, have sailed through Liberian trials and, based on the results, may now advance to Phase III trials.

PledPharma jumps 20% on PhII chemotherapy-induced nerve damage data

PledPharma has posted Phase IIb data linking its oxidative stress protector to a 43% drop in incidence of chemotherapy-induced peripheral neuropathy. The data triggered a 20% jump in the stock price of the company as investors responded to the results and talk of a possible partnership.

Quintiles and Quest team up for lab testing with $575M JV

Months after LabCorp acquired its rival Covance, Quintiles has signed a sweeping agreement with lab testing giant Quest Diagnostics to launch a joint venture focused on clinical trials.