Genentech has a long history of incorporating real-world data into its business, with the myocardial infarction registry it helped set up in the 1990s showing how to achieve better patient outcomes using its drug Activase. And the big biotech has now teamed with PatientsLikeMe to access patient-focused data and research tools.
Lexington, MA-based Curis says the FDA has lifted the partial clinical hold on CUDC-427, which was instituted after the death of a patient in a Phase I study of solid tumors and lymphoma.
More than two years ago Roche CEO Severin Schwan picked the cancer drug MetMAb out of the pipeline as one of the company's top blockbuster prospects. But on Monday its oncology R&D arm at Genentech was forced to halt a Phase III combo study matching MetMAb with Tarceva in a failed effort to block metastasis in non-small cell lung cancer after an independent monitoring group flagged the attempt for futility.
Roche last week said it had resolved packaging issues that resulted in the interruption of supplies of its liquid Tamiflu flu fighter. But while the interruption lasted less than two weeks, it couldn't have come at a worse time: at the beginning of the first quarter and right in the middle of the flu season. Last year, Tamiflu sales provided the Swiss drugmaker with a nice boost to first-quarter sales.
Liquid Tamiflu is back. Roche says the temporary shortage of the liquid version of its flu fighter that it warned of two weeks ago is resolved and should stay that way for the rest of flu season.
Roche didn't waste much time in replacing former R&D guru Hal Barron, tapping oncology head Sandra Horning to serve as its next chief medical officer and head of global product development.
A short production interruption at a drug manufacturing plant doesn't generally elicit a lot of publicity--unless it involves a drug treatment for children during the flu season. And so the FDA let it be known Wednesday that there may be spot shortages of Tamiflu liquid because of manufacturing issues at a Genentech plant.
The Bill & Melinda Gates Foundation has picked Susan Desmond-Hellmann to lead as its next CEO, bringing the Genentech veteran's years of experience in drug development and academia to one of the largest charitable organizations in the world.
It is now two months since Google sparked speculation by unveiling vague but ambitious plans to enter the biotech sector. Details of what the spinout, called Calico, will do are still limited, but we now know some of the people who will run the show. Unsurprisingly, Google has poached some heavy hitters.
A year after Curis agreed to pay Genentech $9.5 million upfront to license the early-stage cancer therapy recoded as CUDC-427 and borrowed $30 million to launch its own study, the FDA has clamped a partial clinical hold on the program following the death of one patient taking the drug.