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.
When Roche bought Genentech in 2009, it swelled its biologics production footprint, but it was unsure whether biosimilar completion would leave it with excess capacity. The doubt prompted Roche to shutter a Genentech cell culture facility before it ever produced a drug, a decision it is now overturning.
A number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia, and Roche's Genentech and Biogen Idec have gotten there first. The FDA today approved their drug Gazyva, a successor to Roche's Rituxan that it hopes will offset some of massive sales that drug generates when it finally succumbs to biosimilar competition.
When John Reed headed up Sanford-Burnham Medical Research Institute, the marathon runner was well known for early starts and fast finishes. And now, as the new head of Roche's Basel-based Pharma Research and Early Development group--better known as pRED--he's in for the run of his life. Read the full feature >>
Perjeta is now the first cancer drug approved to treat patients before surgery. Developed by Roche's Genentech unit, and already approved for women with advanced HER2-positive breast cancer, Perjeta can now reach a huge new group of patients at early stages of the disease.
Google has played on the fringes of healthcare for years, investing in 23andMe, DNAnexus and other bio startups through its venture capital unit. Now it has set up its own biotech, outlined vague but wildly-ambitious goals, and hired ex-Genentech CEO Art Levinson to lead the company.
You might call Perjeta a guinea pig. The new breast cancer drug from Roche's Genentech unit could soon become the first approved for cancer patients before they've had surgery. It would also be the first approved under new FDA guidelines for speeding cancer drugs to patients with early-stage disease.
Video games have been gaining momentum in healthcare because of various patient benefits, and Genentech's foundation has awarded grant money to propel more games about fighting cancer into the hands of pediatric patients, Medical Marketing & Media reported.
Array BioPharma has another asset on deck for a potential partnership. The company has touted upbeat Phase II data for an experimental drug in patients with allergic asthma, and the company plans to seek a partner to fund further studies.