Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Actelion racing to regulators after potential blockbuster PAH drug aces PhIII

Shares of Switzerland's Actelion spiked 15% Monday morning after the biotech reported that its next-gen oral pulmonary arterial hypertension drug selexipag proved a success in Phase III, setting up a showdown with regulators for a drug that's widely billed as a likely blockbuster.

Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle

Biogen Idec and AbbVie announced Monday morning that their once-monthly multiple sclerosis drug daclizumab has cleared key hurdles in a Phase III study, setting the stage for a marketing pitch to regulatory authorities.

UPDATED: Bernstein analyst predicts a likely flop for Vertex's crucial CF combo study

There's no mistaking Geoffrey Porges' opinion on Vertex's chances of success with its combo study of VX-809 and Kalydeco. After spending the weekend at the European Cystic Fibrosis Society meeting in Sweden, the prominent Bernstein analyst came away even more soured on the experimental CF drug's potential, with pivotal data for the combo looming on the horizon.

On heels of a Celgene deal, Agios adds promising data on leukemia drug

On Friday, Celgene followed up on its aggressive $130 million upfront deal to land an option on Agios' experimental therapies by locking in development and commercialization rights to its lead drug, AG-221. On Saturday, Agios explained why, detailing Phase I data that showed an objective response among more than half of the evaluable patients and a complete response from 6 of 25.

Sanofi, Regeneron add positive PhIII data on key RA drug

Sanofi and its close development partner Regeneron added some positive year-long results to the promising Phase III rheumatoid arthritis data that they've been gathering on sarilumab, an antibody that is billed as one of the pharma giant's top late-stage drug prospects.

Inovio shares dive on cervical cancer vax speculation

Shares of Inovio Pharmaceuticals took a hit Tuesday on rumors that CEO Joseph Kim was "walking back expectations" for a Phase II study of DNA vaccine candidate VGX-3100 in women with cervical precancerous lesions.

Eli Lilly's key franchise drug ramucirumab flops in PhIII liver cancer study

Lilly has hit another setback in its effort to expand the market range for its key cancer drug ramucirumab, recently approved as Cyramza for stomach cancer.