Munich’s Wilex is cutting its losses after repeated setbacks for its kidney cancer drug, planning to lay off 80% of its employees and discontinue clinical development. …read more Source: Wilex cuts 80% of its staff as it pulls the plug on a once-promising cancer therapy     

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 […]

AstraZeneca is pulling the plug on an Indian research shop as part of its ongoing R&D re-think, planning to shed another 168 jobs as it moves away from neglected diseases and focuses on spaces with higher growth potential. …read more Source: AstraZeneca is cutting 168 jobs as it shutters an Indian R&D site     

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     

…read more Source: Amgen extends PhIII sweep with more promising results for PCSK9 drug     

Merck skated through an FDA panel for its latest oral immunotherapy for allergies, as a group of agency advisers found the drug to be safe and effective for counteracting ragweed pollen. …read more Source: Merck’s allergy pill sways an FDA panel but faces a long road to success     

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     

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     

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 […]

After an FDA reviewer found no cause for alarm in pivotal data for Merck’s newest allergy drug, the fate of the company’s oral treatment for ragweed pollen allergies lies in the hands of agency advisers and choosey payers. …read more Source: Merck readies its latest allergy pill for FDA scrutiny and an uphill battle