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A trial of a cervical cancer treatment by New Jersey biotech company Advaxis demonstrated it could extend life further than existing treatments in women with persistent, advanced forms of the disease. Read More
HHS will collaborate with biopharmaceutical giant AstraZeneca on an antibiotic initiative as part of a biodefense preparedness plan for dealing with public health threats. Read More
California-based biopharmaceutical companies Amgen and Xencor entered into a research and license agreement that could be worth as much as $1.7 billion to develop and commercialize therapeutics focused on cancer immunotherapy and inflammation. Read More
The FDA awarded Bristol-Myers Squibb’s Opdivo a breakthrough therapy designation for metastatic renal cell carcinoma, adding another potential indication to the growing list for the PD-1 inhibitor. Read More
XenoPort announced its Phase 2 clinical trial of an experimental drug for patients with moderate-to-severe chronic psoriasis met its primary endpoints. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
The FDA has granted Catabasis Pharmaceuticals a rare pediatric disease designation for an investigational drug used to treat Duchenne Muscular Dystrophy, paving the way for priority review, the company said Monday. Read More