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San Diego-based Rakuten Aspyrian nabbed $150 million in a Series C financing round. The funding provides the company with a total of $238 million in equity. Rakuten Aspyrian will use the funds to drive its lead therapy into Phase III trials.
Shire plc snagged approval from the U.S. Food and Drug Administration for Takhzyro (lanadelumab-flyo), a prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The U.S. Food and Drug Administration has posted new draft guidance that will guide drug and medical device manufacturers that aim to develop treatments for “the underlying pathophysiology and structural progression” of osteoarthritis (OA).
Shares of Innovate Biopharmaceuticals are up more than 7 percent in premarket trading after the company announced it signed an agreement with privately-held Amarex Clinical Research to provide data management and biostatistics for its planned Phase III celiac disease trial.
Pfizer and Astellas Pharma announced they have amended the protocols for two Phase III clinical trials, ARCHES and EMBARK, to evaluate Xtandi (enzalutamide) in hormone-sensitive prostate cancer (HSPC). Both trials will wrap sooner than planned as a result.
AstraZeneca has seen another setback in a late-stage trial for chronic obstructive pulmonary disease (COPD) treatments. The latest stumbling block includes a failure for AstraZeneca’s investigational treatment to distinguish itself from a drug already marketed by rival GlaxoSmithKline.
By many standards, and certainly by the way the media covers it and industry promotes it, immuno-oncology therapies using CAR-T are revolutionizing cancer treatments. But what if, as the saying goes, they threw a revolution and nobody came? Or more precisely, what if they threw a revolution and no one was willing to pay for it?
Madison, Wisconsin-based EXACT Sciences stocks climbed as much as 21 percent in premarket trading in response to a deal with Pfizer to co-market Exact’s Cologuard non-invasive colon cancer test.
The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for (ulipristal acetate).
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