Many of the Big Pharma players have paid hundreds of millions, sometimes billions, of dollars to settle federal litigation accusing them of pushing their products for unapproved uses. Now tiny Amarin has won the FDA's blessing to do just that if it will drop its free speech lawsuit against the agency, providing the opening U.S. pharma has been looking for to market drugs for uses other than those for which they are approved. Celldex's Rintega (rindopepimut) has proved to be a bust in glioblastoma. The biotech reported this morning that it is cutting a Phase III study short after independent monitors concluded that the drug failed the endpoint for improving overall survival. Thermo Fisher Scientific is no stranger to M&A. In the past few years, the company has struck a series of deals to beef up in diagnostics, including its $13.6 billion pact for DNA sequencing giant Life Technologies. Now Thermo Fisher could be revving up its dealmaking engine again, one analyst says. Hong Kong-based Hutchison China MediTech, or Chi-Med, has detailed its plans to raise $100 million on the Nasdaq in an IPO this month, placing its overall value a nearly $2 billion and joining a surge of investor interest in China-focused biopharma plays regionally and abroad. One pharma has already chalked up 15 minutes of Kardashian-fueled fame. Now, another drugmaker has signed up for its turn in the family limelight. Last March, Orexigen landed in hot water with researchers, the FDA and marketing partner Takeda when it blabbed some early trial results that falsely suggested its obesity med could improve cardiovascular outcomes for patients. Just over a year later, it's still facing the consequences. GlaxoSmithKline has renewed its contract with business process management company WNS. The extension of the relationship means GSK will continue to rely on WNS for research and analytics services until at least December 2020. Pfizer's CDK inhibitor Ibrance made a splash last year when it won a speedy FDA nod for breast cancer, with competitors from Novartis and Eli Lilly in pursuit. But this class of drugs may have applications beyond breast cancer: researchers from Mount Sinai's Icahn School of Medicine have identified a CDK4/ARK5 inhibitor as a potential new weapon against the fatal blood cancer, multiple myeloma. With its closely watched Duchenne muscular dystrophy drug eteplirsen facing an uncertain fate at the hands of the FDA, Cambridge, MA-based Sarepta Therapeutics said it is consolidating operations and shuttering a research facility in Corvallis, OR. Corvia Medical has scooped up a potential buyer with a purchase option deal, but the Massachusetts-based startup is remaining hush-hush on the identity of the strategic partner and the deal terms. The deal likely hinges on the outcome of an upcoming trial for its transcatheter InterAtrial Shunt Device to treat heart failure, or the subsequent FDA approval for which it's expected to provide the basis. Widening the field further, Vaxart, Immunovaccine and Mayo Clinic are joining a slew of biotechs and pharmas either exploring or embarking on Zika vaccine development. Grifols, the Spain-based specialist in blood plasma products, last year opened a $370 million plasma fractionation plant in Clayton, NC, but has now decided that is not enough to meet growing demand. It says it will invest $360 million to build out four projects to ensure it has the capacity it needs over the next 15 years, including two new facilities in Clayton. Shanghai-based WuXi AppTec said its Shanghai SynTheAll Pharmaceutical's Changzhou facility started initial operations in February, showcasing manufacturing and clinical prowess and speed that can attract investors in China and abroad. The fault for the death of one patient and the serious injuries to 5 others in a French drug trial is down to the medicine itself, rather than the CRO and pharma company conducting the study. This is according to a new report by the French National Agency for Drug Safety, released this week. Ceva Santé Animale wants to nab a spot in the top 5 of the animal health sector by 2020. The company has already made strides toward achieving this goal and now, it's moving one step closer with promising 2015 numbers driven by strong sales in its poultry business. Biotech startups often tout promising animal studies, but beware, at least when it comes to cancer drug delivery, success in mice rarely translates to success in humans, Purdue University researchers say. New in vitro tests that emulate the tumor micro-environment are needed. | 
