Late Monday, Pfizer Inc. disclosed its decision to halt a Phase III trial (B1931008) of inotuzumab ozogamicin, an investigational antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting CD22, administered in combination with Rituxan (rituximab, Roche AG and Biogen Idec Inc.), in relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma (NHL).
Shares of Xenoport Inc. (NASDAQ:XNPT) dropped almost to the bottom of their 52-week range early Monday, opening at $5.04 after the company terminated its late stage arbaclofen placarbil (AP, previously XP19986) program in spasticity due to multiple sclerosis (MS) after a pivotal Phase III trial failed to demonstrate statistically significant improvement compared to placebo.
Gilead Science Inc.'s oral targeted cancer drug, idelalisib (GS-1101), made a splash last week when the American Society of Clinical Oncology (ASCO) unveiled thousands of abstracts scheduled for presentation at next week's annual meeting in Chicago. In a press conference Wednesday afternoon, Jennifer R. Brown, director of the Chronic Lymphocytic Leukemia Center at the Dana-Farber Cancer Institute, provided Phase I findings suggesting idelalisib, as a single agent, has the potential to stave off the need for additional treatments for relapsed/refractory chronic lymphocytic leukemia (CLL).
Taking an inventive route to drug development, Oncos Therapeutics Ltd. has its roots in a type of compassionate use program that was started in 2007 at the international comprehensive cancer center, Docrates, in Helsinki, Finland.
PTC Therapeutics Inc. made last week a biotech trifecta for initial public offerings (IPO), filing an S-1 with the SEC seeking to raise up to $85 million. Earlier, gene therapy firm bluebird bio Inc. and Esperion Therapeutics Inc., a company working on a drug to lower LDL-cholesterol, joined the IPO queue.
The American Society of Clinical Oncology (ASCO) released the first of more than 4,700 abstracts late Wednesday in anticipation of its 2013 annual meeting, scheduled to attract more than 30,000 participants to Chicago from May 31 to June 4.
Astellas Pharma Inc. jumped on the bandwagon of big pharma restructurings, disclosing plans to close U.S. units OSI Pharmaceuticals LLC and Perseid Therapeutics LLC this year and to downsize Astellas Research Institute of America LLC to focus on central nervous system therapies.
Relypsa Inc., which last summer closed an $80 million Series C to fund its pivotal Phase III program of nonabsorbed oral potassium binder patiromer (RLY5016), has fully enrolled the two-part trial, which is evaluating efficacy and safety in treating hyperkalemia in patients with chronic kidney disease (CKD).
Hours after reporting its first quarterly earnings as a commercial entity following FDA approval of Kynamro (mipomersen) in January and subsequent launch of the antisense drug, Isis Pharmaceuticals Inc. turned its attention to other candidates in its pipeline.
Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD).
