Sanofi Gets $37.6mn Federal Contract to supply Leukine-The U.S. Department of Health and Human Services’ Biomedical Research and Development Authority (BARDA) awarded Sanofi $SNY with a $37.6mn contract to supply and manage inventory for Leukine (sargramostim) for the potential treatment of acute radiation syndrome. Earlier in 2013, the drug-maker was awarded a $36.5mn contract to support a late-stage development and procurement of Leukine. The funds will help evaluate use of Leukine in patients acutely exposed to myelosuppressive doses of radiation. It plans to submit a supplemental Biologics License Application (sBLA) to the FDA in 2017.
PTC Therapeutics presents ataluren data in DMD-PTC Therapeutics $PTCT has presented a data from an open-label extension trial (study 019) evaluating the potential of Translarna (ataluren) in preserving lung function in patients with Duchenne muscular dystrophy (DMD). The result of the study is being presented today in a company sponsored symposium. The metric being used to evaluate ataluren effect is forced vital capacity (FVC), a measure of lung function that correlates with disease progression and mortality.
Mylan accused of Overpricing EpiPen-The U.S. government health plans spent more than $1bn on Mylan’s $MYL EpiPen between 2011 and 2015; however, the company is blamed of cheating taxpayers by underpaying rebates by hundreds of millions of dollars. Andy Slavitt, Acting Administrator at the Centers for Medicare and Medicaid, said Mylan wrongly classified the emergency epinephrine product as a generic, when it should have been classified as a brand-name product.
Red Hill Bio Expands Enrollment in Late Trial of Crohn’s Candidate-RedHill Biopharma $RDHL altered the protocol in its Phase 3 study, MAP US, assessing RHB-104, a combination antibiotic, for the treatment of Crohn’s disease. It has also expanded its enrollments from 270 to 410 and updated the sample size calculations to lower the detectable effect from 21% to 15%, which it says will reveal a "more clinically expected" treatment effect.