Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Receptos shares spike as oral drug reduces brain lesions in PhII MS trial

Last year Receptos pulled off one of the most successful biotech IPOs in a red-hot market for new offerings, largely on the promise of a midstage study underway for its oral multiple sclerosis drug. And this morning investors spurred a 35% spike in its share price as investigators spelled out promising data from that Phase II trial.

Eli Lilly gets on the trial transparency bandwagon

In keeping with changing industry standards, Eli Lilly has joined the host of drugmakers opening up their data vaults, going further than some but not quite baring it all.

Amgen is gunning for approval of viral cancer vaccine, adds positive combo data

CHICAGO--Amgen's big Phase III effort on the viral cancer vaccine talimogene laherparepvec may have fallen just shy of hitting the mark for a key metric on overall survival, but after hitting the primary goal on durable response rates for patients with melanoma, the big biotech says it plans to move ahead and seek an approval to start selling the treatment. And investigators here at ASCO have also begun to add some new data to back up its potential as a combination cancer therapy.