| This week's sponsor is Premier Research. | | | Clearing the Path for Orphan Drug Development
The unmet therapeutic need in rare disease is huge, but so are the cost and complexity of drug development. Read our white paper to see how the FDA and EMA are easing the path to regulatory approval. Premier Research. It's what we do. Best. |
Top Stories Thursday, December 8, 2016 Allaying concerns from some quarters that it wouldn’t be passed this year, and coming just one month after the presidential election, the 21st Century Cures Act has passed the Senate as it looks to shake up the way in which the FDA works. Thursday, December 8, 2016 The European Medicines Agency has accepted Regeneron and Sanofi’s dupilumab for review. Dupilumab’s filing is chock-full of clinical trial data showing it improves multiple outcomes in patients with moderate-to-severe atopic dermatitis, leading to the IL-4/IL-13 inhibitor being widely seen as the next blockbuster to roll off the lot at Regeneron. Thursday, December 8, 2016 Armed with debut financing of $44.5 million, Cambridge-based startup TCR2 Therapeutics is poised to advance its cell-based cancer therapies toward the clinic. Thursday, December 8, 2016 South Korean biotech Eutilex has seen a $21 billion KRW ($18.9 million) Series A funding boost as it looks to take its lead cancer med into midstage testing. Wednesday, December 7, 2016 Abbott has been squirming for months over its Alere acquisition, even offering the diagnostics maker $50 million to exit the deal. Now, Abbott is putting its foot down, filing a complaint to terminate the deal once and for all. Wednesday, December 7, 2016 Researchers at Toronto’s Princess Margaret Cancer Centre have landed on a new biomarker that can predict if patients with acute myeloid leukemia will respond to standard treatment. It could help identify which patients would benefit by skipping regular chemo altogether and going straight to enrolling in clinical trials. Wednesday, December 7, 2016 If President-elect Donald Trump is to “reform” the FDA as promised, he might start with an outsider pick for commissioner. According to Bloomberg’s sources, the incoming administration is considering one that's far outside the usual box in tech capitalist Jim O’Neill. | | | After a tough year, NW Bio says it is pulling out of its Nasdaq listing and going over to trading on the OTC market. Release GTx has posted some positive top-line data from its small, ongoing open-label enobosarm midstage test in women with advanced, estrogen receptor positive and androgen receptor positive breast cancer. Statement Lilly too says its latest study of its breast candidate abemaciclib had positive results after hitting its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation. Release | |
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