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...

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...

Seattle Genetics scores $900M cancer pact with Genentech

Genentech has anted up $12 million to expand its development pact for Seattle Genetics' antibody-drug conjugate (ADC) technology. And the Seattle biotech will now be able to play for a pot of cash that could swell to $900 million in fees and milestones. Genentech has already shelled out $30 million to Seattle Genetics over the past eight years. Impressed by the technology's ability to match a tumor-targeting antibody with a cancer-killing toxin, Genentech now wants to expand its group of...

NovImmune inks deal, eyes possible IPO

Genentech has forged a licensing pact with Geneva-based NovImmune for an early-stage IL-17 antibody that may be useful in treating inflammatory and autoimmune diseases. And the Swiss biotech, which has raised SFR$154 million, says the deal may help advance plans for a possible IPO....

Genentech licenses UK package of small molecule drugs

London-based MRC Technology has inked a licensing pact with Genentech for a package of small molecule drug candidates for neurological conditions. MRC gets an unspecified upfront payment along with a slate of potential milestones for the licensing deal, the first major small molecule collaboration MRC has struck for its Centre for Therapeutics Discovery. CTD was formed a year ago from the MRC Technology Drug Discovery Group. MRC Technology not only works with targets from the U.K.'s Medical...

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...

Curis shares plunge after lead drug flunks cancer trial

Cambridge, MA-based Curis (CRIS) has been handed a significant setback on its lead cancer program. The developer announced this morning that GDC-0449 flunked the primary endpoint in a Phase II colorectal cancer trial mounted by its partner Genentech, failing to outperform a combination of Avastin and chemotherapy. The news quickly lopped 46 percent off the value of its shares. Researchers behind the 199-patient trial were looking to see whether the drug, in combination with Avastin and chemo,...

Evotec inks drug discovery deal with Genentech

Evotec has signed a multi-year integrated drug discovery alliance with Roche's Genentech to discover novel small molecule therapeutics. Evotec will use its integrated and innovative drug discovery platform against targets nominated by Genentech to identify development candidates. Financial details of the deal were not disclosed. "We are proud that Genentech, one of the premier biopharmaceutical companies worldwide, has selected Evotec's scientists and innovative drug discovery platform to...

New licensing chiefs for AZ, Genentech talk deal strategy

AstraZeneca's new licensing chief, Shaun Grady, traveled to Chicago to spread the word about the pharma company's new partnering strategy at BIO. AstraZeneca has been reengineering its approach to drug development recently, moving away from an in-house approach to a new strategy that will look for external deals to drive 40 percent of its R&D. The pharma company has already outlined plans to drop work in schizophrenia, bipolar disease, depression, anxiety, acid reflux, thrombosis, ovarian...