Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Questions on MannKind's inhaled insulin PhIII data cloud Afrezza's future

Early yesterday MannKind's Phase III data for Afrezza looked like a big hit with investors. But after a second look at the trial results, analysts' enthusiasm--and MannKind's share price--waned.

UPDATED: MannKind posts positive PhIII diabetes responses for inhaled insulin

After being dogged by regulatory setbacks and demands for new trials, MannKind says it gathered clearly positive late-stage data on its inhaled insulin Afrezza from a pair of Phase III studies on Type 1 and Type 2 diabetes. And its share price quickly surged more than 30% this morning on the news.

Eli Lilly's troubled Erbitux successor scores a win in PhIII lung cancer trial

The pharma giant says that the late-stage study produced promising overall survival data for non-small cell lung cancer, setting up a key regulatory filing in 2014.

Bristol-Myers buries another depression drug after PhII flops

BMS-820836--an investigational triple reuptake inhibitor in a pair of midstage studies for treatment-resistant depression--failed the primary endpoints when compared to Eli Lilly's Cymbalta (duloxetine).

Vical discards melanoma immunotherapy Allovectin after PhIII failure

San Diego-based Vical recruited 390 patients to test Allovectin (velimogene aliplasmid), a cancer immunotherapy that's been in the clinic for years. The biotech had been bullish about its Phase II data. The company didn't disclose any data this morning, saying that it would release results at a later scientific conference.

Dana-Farber sees promise in leukemia vaccine trial

Stem cell transplants have improved treatment of patients with chronic lymphocytic leukemia (CLL), but the risk of relapse remains. Advances are needed to extend 5-year progression-free survival rates beyond the currently achieved 64%, and Dana-Farber thinks a vaccine could help.

Sanofi advances C. diff vaccine into PhIII

Sanofi Pasteur is entering an important period for its vaccine business. The success of its big bet on a dengue fever vaccine hangs on upcoming late phase data. And its clostridium difficile jab has just entered Phase III, too.

NIH pushes for biomarker research to catch up with needs of kids

In an effort to advance drug and disease research in children, a unit of the National Institutes of Health aims to fund studies of biomarkers of adult ailments for use in pediatric patients.

Analysts grow skeptical about Sanofi's $800M bet on dengue vaccine

Sanofi is betting an estimated $800 million for research and a new facility to produce an experimental vaccine for dengue--and not all analysts are giving the pharma giant ($SNY) very good odds at success.

Isis dumps rheumatoid arthritis effort after antisense drug flunks PhII

Isis Pharmaceuticals has opted to throw in the towel on its rheumatoid arthritis program for ISIS-CRP Rx, but the biotech says it will continue to plug away at studies of the antisense treatment for other diseases, including a mid-stage trial for atrial fibrillation due to read out next year.