Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Regeneron, Sanofi herald a blockbuster contender with groundbreaking study

If you want to understand why Regeneron R&D chief George Yancopolous gets a king's ransom in annual compensation, you need look no further than the Phase IIb data that has just been posted on dupilumab for severe eczema.

Alzheimer's R&D suffers as trial failure rate hits an 'astounding' 99.6%

Jeffrey Cummings is directing one of the few early-stage studies underway on an Alzheimer's therapy. And now that he's scanned the records of clinicaltrials.gov, he's acutely aware of just how small his chosen field is.

PaxVax' oral cholera vaccine succeeds in PhIII challenges

PaxVax' single-dose oral cholera vaccine candidate, PXVX0200, posted positive results in a pair of challenge studies, the company announced earlier this week.

Agenus brain cancer vaccine boosts survival in PhII trial

Patients with a lethal form of brain cancer lived nearly twice as long as expected after receiving Agenus' ($AGEN) Prophage vaccine in a Phase II study, according to the company.

Regado takes a beating as big PhIII study faces safety review

Shares of Regado Biosciences took a nasty beating Thursday evening after the company put out the word that enrollment in its big, self-funded Phase III study of a new anticoagulant had to be put on hold so that a safety monitoring committee could check out "serious adverse events related to allergic reactions."

UPDATED: Agenus' genital herpes vax cuts viral load 75% in PhII

After hitting its primary endpoint in a Phase II study last fall, Agenus was already leading a Sanofi-NIH collaboration in efforts to develop the first genital herpes vaccine. Now, it's built on that lead with new Phase II results for its therapeutic candidate, HerpV, which achieved statistical significance in reducing viral load.

Aerie shares soar as glaucoma combo succeeds in PhIIb eye study

Aerie Pharmaceuticals says that a combo glaucoma drug adding its own treatment to the best-selling standard in the field topped the blockbuster solo therapy in a Phase IIb trial. The results set the stage for a confirmatory Phase III trial, sending its share price soaring more than 40% on Wednesday morning.

Ohr touts visual acuity results as PhII eye study fails primary goal

Shares of Ohr Pharmaceutical slipped and then bounced back this morning after the biotech announced that a mid-stage study of Squalamine eye drops failed the primary endpoint in reducing the number of injections of Lucentis among patients with wet, age-related macular degeneration. The New York-based biotech touted an improvement in visual acuity among the small group of patients in the Phase II trial, which drew a few cheers among the analysts following the company.

FDA review red-flags AstraZeneca's case for ovarian cancer drug olaparib

AstraZeneca's reconstructed case for the cancer drug olaparib is built on the fundamental premise that the new management team at the pharma giant is a whole lot smarter than the old crew. After a retrospective analysis found a subgroup response in the data for ovarian cancer, CEO Pascal Soriot not only ordered the team to renew its pursuit of an approval, he later assigned a $2 billion peak sales value to the program.

Parexel rolls out new eClinical tech to speed up study start-up

Parexel International has reformatted its clinical trial management software, streamlining its services with an update the company believes can help its clients start studies faster.