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 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.
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.
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.
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.
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.
Roche and biotech partner Exelixis say their melanoma-fighting combination therapy met its primary endpoint in Phase III, clearing the way for an FDA application and giving the latter company a boost in its share value.
South San Francisco biotech Exelixis and partner Roche say their in-development combo treatment for melanoma extended survival in an early-stage trial, setting the stage for Phase III results that could make or break the treatment's future.
Hell hath no fury as a disappointed investor who bet wrong on a biotech catalyst. The execs at Exelixis got a three-course serving of that anger this morning as its stock went into a 35% nose dive--after the biotech announced that its interim analysis was complete and the Phase III prostate cancer study for cabozantinib would go to its conclusion.
Analysts at GlobalData took a quarterly snapshot of the R&D expenses for a big batch of mid-cap biotechs and concluded that rising research costs were eroding corporate profitability. And they pinned the blame squarely on the pricey hunt for new cancer drugs.