Switzerland's Molecular Partners is convinced that it has created a better delivery vehicle for cancer drugs, and Roche is promising to pay up to a billion dollars-plus to see if they're right.
Roche's Kadcyla, a drug some refer to as a "super Herceptin," was approved by the European Commission Wednesday for patients with previously treated HER2-positive advanced breast cancer.
A European Medicines Agency probe found that Roche failed to flag tens of thousands of side-effect reports, EMA reviewers said. But sifting through those unreported adverse events didn't turn up any new safety worries on Roche's leading drugs, as some had feared.
Fresh off a $46 million funding round, Germany's immatics has inked a deal to collaborate with Roche on cancer therapies, signing an end-to-end agreement that could bring in more than $1 billion in milestones.
With new trial data, Roche has more support for its thesis that Rituxan successor Gazyva beats the original. Combined with the chemo drug chlorambucil, Gazyva helped patients live a median of 26.7 months without their cancer progressing, compared with 15.2 months for the Rituxan-plus-chlorambucil combination.
Roche's Ventana Medical Systems will pair off with drug developer Incyte to create companion diagnostic tests designed to work with the company's cancer drugs. Once again, the personalized medicine movement moves forward.
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.
Just as biosimilar competition creeps up on blockbuster Rituxan, Roche and partner Biogen Idec have won FDA approval for the cancer drug's heir, marking the first success story for the agency's breakthrough drug designation.
A team from IBM Research and the Institute of Bioengineering and Nanotechnology in Singapore have designed a Vitamin E-based hydrogel that can release Roche's cancer antibody Herceptin under the skin for several weeks.