Food and Drug Administration (FDA)

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In March, San Diego-based Orexigen Therapeutics filed for bankruptcy. Back in April, Orexigen entered into an asset purchase deal with Nalpropion Pharmaceuticals to sell most of its assets, subject to court approval.
The U.S. Food and Drug Administration (FDA) approved New York-based Progenics Pharmaceuticals’ New Drug Application (NDA) for Azedra for adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is the first and only therapy approved for these indications.
Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical, indicated their guadecitabine (SGI-110) missed its co-primary endpoints in acute myeloid leukemia (AML).
Investors have been skeptical about AbbVie lately, particularly after last week’s second-quarter financial report. That doesn’t make all that much sense, given that the company reported net revenues of $8.278 billion for the quarter.
Liquidia Technologiesnlaunched a successful initial public offering on July 25, raising $50 million. Neal Fowler, the company’s chief executive officer, and Kevin Gordon, Liquidia’s president and chief financial officer, took time out to talk with BioSpace about the company and where it’s headed.
Achaogen, headquartered in South San Francisco, announced that as part of its strategic update and corporate restructuring, it will eliminate 80 positions, or about 28 percent of staff.
Although the overall stock market has been a bit jittery as the result of a trade war, biotech stocks have been surprisingly steady—at least in comparison to their usual volatility.
Bristol-Myers Squibb reported a strong second quarter, with total revenues of $5.7 billion, up 11 percent from the same quarter in 2017, when it reported $5.144 billion. Sales were driven by Eliquis (apixaban) and Opdivo (nivolumab).
Despite what has been described as a series of missteps in the last year, Celgene’s second-quarter financial report was promising.
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