Alexion
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Evaluate recently published the Vantage Pharma, Biotech and Medtech 2018 in review report. The annual report offers insights into the previous year’s activities in biopharma and the medical device industry.
Two of the three drugs that were up for review in mid- to late-February received much earlier approval in December 21, the day before the federal government shutdown. The shutdown ended on January 25, 2019.
Shares of Fortress Biotech have skyrocketed more than 62 percent in premarket trading after its subsidiary Caelum Biosciences forged a deal worth up to more than $500 million with Alexion Pharmaceuticals.
Boston-based Alexion’s Ultomiris (ravulizumab-cwvz) hit its primary objective in its Phase III study of complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS).
The Orphan Drug Act (ODA) was enacted on January 4, 1983. It was designed to encourage the development of drugs for rare diseases. The law was amended the following year to define rare diseases as ones that affect fewer than 200,000 people in the U.S. But it also included drugs that affect more than 200,000 people the costs of developing and marketing the drug in the U.S. would exceed revenue from U.S. sales.
Alexion Pharmaceuticals and Stemline Therapeutics both secured FDA approval for their drugs.
Biopharma companies name new members of their leadership teams. Who made big moves this week?
For the second time in less than one week, Dicerna Pharmaceutical has forged a licensing agreement for its GalXC RNAi technology platform. This time Dicerna and Eli Lilly have struck an agreement to use the platform for up to 10 cardio-metabolic, neurodegeneration and pain targets.
Shares of Alexion Pharmaceuticals are up nearly 4 percent in premarket trading after the company announced it has teamed up with Dicerna Pharmaceuticals on the development of an RNAi therapeutic for the treatment of complement-mediated diseases.
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