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Archive for January, 2014

29
Jan

Medivation and Astellas Pharma unveiled final results on primary and secondary efficacy endpoints from their Phase III PREVAIL trial of Xtandi (enzalutamide), showing that the drug delayed tumor growth and prolonged the lives of patients with metastatic prostate cancer who previously have not undergone chemotherapy. …read more Source: Astellas, Medivation’s cancer drug Xtandi scores new […]

29
Jan

The expected deluge of first-quarter biotech IPO filings roars on with new filings from Flexion Therapeutics and Aquinox Pharmaceuticals, two drug developers looking for a combined $123 million and hoping 2013’s bull market carries over into the new year. …read more Source: IPO hopefuls look to extend biotech’s window with $123M in fresh pitches     

28
Jan

Years of lax regulations helped India build a booming market for clinical trials, but a recent move to strengthen patient protections has deflated demand and last year saw just 19 studies get underway in the country, according to The Pharma Letter. …read more Source: Indian clinical trials plummet 93% as local regs tighten up     

28
Jan

Thanks to some high-profile failures to replicate preclinical findings in some of the world’s leading journals, the call for reform has reached a fever pitch, and National Institutes of Health Director Francis Collins has taken up the baton. …read more Source: NIH’s Collins vows to tackle science’s reproducibility problem     

28
Jan

The FDA’s breakthrough therapy designation program has been up and running for more than a year, and while the industry’s excitement has yet to wear off, it remains to be seen whether the initiative will be the boon drug developers expect, researchers say. …read more Source: The jury’s still out on the FDA’s ‘breakthrough’ designation […]

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