Latest Headlines

Latest Headlines

Genentech, Exelixis win FDA OK to market cobimetinib combo for skin cancer

Just weeks after announcing a fresh batch of promising Phase III data, the FDA has handed Genentech and its biotech partner Exelixis an approval to market cobimetinib in combination with Zelboraf among a genetically defined group of melanoma patients.

Genentech, Exelixis score another PhIII success for cobimetinib

Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.

Roche, Boehringer and Gilead line up for EU drug approvals

The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.

Exelixis soars as a once-failed cancer drug comes through in Phase III

Exelixis notched a crucial clinical success for its top oncology prospect, meeting its goals in a kidney cancer trial and clearing the way for a lucrative FDA nod.

FDA taps the brakes on Genentech's cobimetinib review

The FDA has opted to delay its review of cobimetinib in order to give regulators more time to consider additional Phase III data provided by Genentech.

Roche and Exelixis roll toward FDA approval with a melanoma cocktail

Roche and Exelixis are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a speedy review.

Roche and Exelixis head to the FDA with their melanoma combo

Partners Roche and Exelixis are making their case to regulators with a melanoma-treating combination therapy, filing an FDA application for the fast-tracked treatment as they await European clearance.

Top 10 Phase III disasters of 2014

Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.

Exelixis axes 70% of workforce after failed foray into prostate cancer

Cancer drugmakers often work to expand the labels for their marketed products by testing them in different types of the disease. But that doesn't always go so well, which can take a hefty toll on smaller companies, as San Francisco-based Exelixis now knows all too well.

UPDATED: Cabozantinib flops against prostate cancer, forcing big job cuts at Exelixis

Late on Monday evening Exelixis put out the word that its crucial late-stage study of cabozantinib flunked a comparison study with prednisone for castration-resistant prostate cancer, triggering a restructuring that will eliminate 70% of the jobs at the biotech.