ATLANTA – Caught between waning investor dollars and a government calling for reduced health care spending, the biotech industry is under more pressure than ever to innovate; the days when firms could create a follow-on molecule that offers only incremental improvements to existing therapies are over.
ImmunoGen Inc. and partner Roche AG reported positive top-line data earlier this year from a Phase II trial testing T-DM1 in HER2-positive metastatic breast cancer patients, but observers had been waiting for the detailed progression-free survival (PFS) numbers. They got those figures Sunday during a presentation at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm, Sweden.
Only hours after announcing a positive recommendation in Europe for terminal complement inhibitor Soliris (eculizumab) in atypical hemolytic uremic syndrome (aHUS), Alexion Pharmaceuticals Inc. won accelerated FDA approval for the drug in that indication Friday, marking what could be only the first label expansion across a host of orphan diseases.
Founded based on an unusual idea for combating multiresistant pathogens, Altermune Technologies LLC is getting a business makeover, inking a joint venture deal with Loxbridge Research LLP that brings the biotech $7 million in seed funding and allows the firm's scientists to focus on advancing the technology.
Set to make idiopathic pulmonary fibrosis drug Esbriet (pirfenidone) available to patients in Germany Thursday, about six months after receiving European approval, InterMune Inc. is bolstering its cash position via two public offerings totaling $231 million.
Back in 2008, biotech companies working on cancer vaccines were not exactly shouting it from the rooftops. In fact, most companies working in the space quietly began branding their drug candidates “immunotherapies” when they met with investors in an attempt to avoid connection with the spate of disappointing headlines such as the ones that ran in BioWorld Today – “Cell Genesys Crushed on Latest GVAX Failure,” “Favrille Sinks on Phase III Failure of Lead Cancer Drug” and “Genitope Dropping MyVax Work, Focusing Instead on Antibodies.” Then Dendreon Corp.’s Provenge (sipuleucel-T) hit its Phase III survival endpoints and won FDA approval...
San Diego-based Panmira Pharmaceuticals LLC is not the traditional biotech start-up. Founded this month to develop assets spun out ahead of Bristol-Myers Squibb Co.'s July acquisition of Amira Pharmaceuticals Inc., the new company really could be labeled Amira Part Two.
Figuring out how to get chemotherapy directly into tumor cells while sparing healthy cells has long been one focus of cancer drug development. The trick is developing a targeted drug delivery vehicle that's actually capable of penetrating cells.
Gilead Sciences Inc. dropped dosing of its non-nucleoside polymerase inhibitor GS 9190 in combination with interferon and ribavirin in the wake of two adverse events in separate studies testing four-drug regimens in patients with hepatitis C virus (HCV), but the news is not expected to affect the firm's all-oral, interferon-free HCV program.
