Having secured an agreement with the FDA on a special protocol assessment (SPA), Advantagene Inc. expects to initiate in mid-2011 a pivotal Phase III trial of lead candidate ProstAtak (AdV-tk) for patients with newly diagnosed prostate cancer. Read More
WASHINGTON – Google searches and all the chatter on social networking sites could become part of the adverse event analyses the FDA uses to gauge the safety of drugs and biologics once they're on the market. Read More
Sutro Biopharma Inc., of South San Francisco, said that a study published in the July 2010 issue of Biotechnology and Bioengineering showed that its biochemical protein synthesis technology platform enabled fast, high-yield protein synthesis and scale-up. In the study, a bioactive cytokine human granulocyte-macrophage colony-stimulating factor was produced at titers of 700 mg/L in 10 hours from frozen extract of Sutro's E.coli-based open cell-free synthesis system. Read More
Takeda Pharmaceutical Co. Ltd. is beefing up its presence in emerging markets and in Europe by paying $13.7 billion in cash for Nycomed GmbH, a privately held mid-sized pharma company. Read More
Repligen Corp., of Waltham, Mass., received approval from the FDA to initiate a Phase I trial of RG3039, a potential treatment for spinal muscular atrophy, an inherited neurodegenerative disease. The company said the double-blind study will evaluate the pharmacokinetic and safety profile of escalating doses of RG3039 in as many as 40 healthy volunteers. Read More
The annual abstract release ahead of the American Society of Clinical Oncology (ASCO) meeting – an event simultaneously heralded and dreaded by Wall Street analysts – landed quietly this year, signaling few surprises ahead of Chicago. Read More
