Roche's blockbuster Xeloda went off patent in December, so it was inevitable that a generic would hit the market at some point. It just wasn't known when. Well, that when is now. The FDA Monday said it had approved a generic from Teva Pharmaceutical Industries.
When Novartis needed a new chairman this year, it chose a pharma executive for the job. Roche, its crosstown rival, is flying in a different direction. The Swiss drugmaker picked Lufthansa CEO Christoph Franz to take Franz Humer's seat at the head of its boardroom table.
Big Pharma and academic groups have made more progress in joining forces on advancing software for translational research on a pre-competitive basis.
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.
Today Roche pharma chief Daniel O'Day threw cold water on the speculation. As FierceBiotech reports, he told Reuters ' Ben Hirschler that ultra-rare diseases just don't fit its business model.
Roche's Ventana Medical Systems arm gained pivotal Chinese regulatory approval for a companion diagnostic that pairs with Pfizer's targeted lung cancer drug Xalkori.
Maybe Roche isn't as interested in Alexion Pharmaceuticals as some recent news reports suggest. Roche pharma chief Daniel O'Day told Reuters ' Ben Hirschler that ultra-rare diseases--an Alexion specialty--just doesn't fit its business model.
Dako got hit with an FDA citation over what the agency says are quality system manufacturing violations involving one of its signature breast cancer diagnostic kits and other related products.
Roche's study looked at Perjeta in combination with Roche's Herceptin and chemotherapy, compared with Herceptin and chemo alone. Patients on Perjeta and Herceptin saw statistically significant improvements in tumor size compared with those in the Herceptin-only arm, the FDA reveiewers noted.
The deal puts Roche--a leader in oncology and a top contender in the immunotherapy field--in the driver's seat on two preclinical therapies that could help marshal a targeted T-cell attack on cancer.