Following up on a successful mid-stage study for the AMD eye drug lampalizumab, Genentech has triggered a pair of Phase III studies to see if it can extend its blockbuster-making R&D rep beyond the cancer drug sphere.
An Alzheimer's treatment from AC Immune and Genentech posted mixed results in a midstage study, missing its coprimary endpoints but performing well in patients with milder symptoms. That leaves Roche, Genentech's parent company, with a big decision to make on whether to take the plunge into Phase III.
Just a year after J&J swooped in to buy up Aragon's game-changing work on prostate cancer in a billion-dollar deal, Roche's Genentech has followed up to buy what remained: a closely-related breast cancer program that promises to change the way that disease is treated.
Developers are razing most of the 40 buildings in the complex, prepping for a sale of the campus either as one parcel or building-by-remaining-building.
Today, Roche put out the word that their PD-L1 drug MPDL3280A won the FDA's coveted breakthrough therapy designation, potentially putting it on an inside track at the agency, which has been hurrying along new medicines in the pipeline.
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.