Roche, Genentech hit with refuse-to-file letter

The FDA has handed Roche and Genentech a refuse-to-file letter for the developers' BLA for trastuzumab-DM1. The drug attaches ImmunoGen DM1 cancer-cell killing agent to Genentech's HER2-targeting antibody, trastuzumab. Roche submitted the BLA in July following a successful Phase II study in which the drug shrank tumors by one-third in women with late-stage breast cancer. The company had hoped to gain accelerated approval of the drug. The FDA says the T-DM1 trials did not meet the...

Roche melanoma drug registers striking results

An experimental personalized cancer therapy from Roche and Plexxikon registered striking results in a recent clinical study, shrinking the tumors in a majority of metastatic melanoma patients who share a common genetic mutation. And a group of experts in the field are lauding the results, saying that the success of this study could help pave the way to one of the first new skin cancer therapies in some 20 years. Of the 16 terminal patients who share a mutation of the BRAF gene, 10 taking...

Curis shares sink as Genentech evaluates lead drug’s fate

Investigators at Roche and Genentech are preparing an in-depth analysis of a fresh crop of mid-stage data on Curis's GDC-0449, with an eye to determine whether the therapy should make the cut for ovarian cancer--less than two months after the same therapy flunked its mid-stage trial for colon cancer. "Following these analyses," wrote Curis (CRIS) in a clinical update, "they (Roche and Genentech) expect to make a portfolio decision regarding whether, or to what extent, they will continue...

Roche files BLA for breakthrough T-DM1 cancer therapy

Wowed by stellar mid-stage data, Roche has filed a BLA for trastuzumab-DM1, or T-DM1, seeking approval to market the pioneering conjugated monoclonal antibody to women with treatment-resistant HER2 positive breast cancer. For Roche, T-DM1 represents a potential mega-blockbuster capable of eventually rivaling Herceptin in the market for cancer drugs. And the filing marks a major milestone for the investigators at Genentech and Immunogen who successfully combined a monoclonal antibody with a...

Post-merger, Roche emulates Genentech’s attitude

When Roche finally closed its $47 billion buyout of Genentech, many industry watchers worried the Swiss company would stifle Genentech's famously laid-back culture. But if early reports are correct, it looks like Roche is the one that's had an attitude adjustment. Roche installed key Genentech leaders at top spots in the company. When it came time to make cuts, Roche's U.S. operations saw the most layoffs. Genentech's ranks have actually grown since the the buyout, according to a...

Analysts turn bearish on Roche’s taspoglutide prospects

After initially tapping taspoglutide as the latest in a string of likely blockbusters-to-be from Roche, analysts are turning sour on the drug's prospects after gaining a close look at the side effect data presented by researchers over the weekend. The once highly touted diabetes drug prospect was put through the ringer earlier in the month when Roche said that it needed to amend trials to watch for side effects like vomiting and nausea, delaying any app for up to 18 months. But a look at...

Roche faces long delay for diabetes drug taspoglutide

Roche has delayed development of its potential blockbuster type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects, including skin reactions and digestive symptoms. Heart and respiratory events were also observed in some patients. Roche will use the additional time to identify patients who are sensitive to the treatment and remove them from clinical trials. The Swiss drugmaker, which is developing the once-weekly injection in conjunction...

Roche plots a survival course but sees no big biosimilar threat

As far as Roche CEO Severin Schwan (photo) is concerned, the European economic crisis will trigger deep cuts in healthcare spending, leaving room for only two types of Big Pharma players: Generic drugmakers with the economies of scale needed to market huge volumes of cheap therapies and innovators who can come up with a new generation of therapies that offer markedly better outcomes for patients. All others, he says, will perish in the economic storm. "If pressure increases you will have...

Roche, Biogen shutter blockbuster ocrelizumab arthritis program

Once tapped as a likely blockbuster, Roche and Biogen Idec have opted to kill their ambitious late-stage development program of ocrelizumab as a treatment for rheumatoid arthritis. Researchers had already been forced to halt trial work earlier this year after patients taking the drug died during the study. And an earlier trial for lupus had already been halted on safety concerns. Once the companies concluded that the anti-inflammatory drug's risk profile fell short of...

Roche adds $201M in milestones to Galapagos R&D pact

Belgium's Galapagos has agreed to expand its R&D collaboration with Roche on new COPD drugs, gaining an extra €150 million in milestones as it broadens its hunt for new drugs to treat smoker's lung. Roche is adding the new set of milestones on top of the €400 million it originally committed to back in January when the two companies formed an alliance to advance new antibodies for the condition. This new deal expands the scope of the alliance to potentially include peptides,...