FDA
Shares of Novo Nordisk are down about five percent this morning after the company reported an overall decline in sales during the second quarter of this year. Sales were particularly disappointing in North America.
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Shionogi, based in Osaka, Japan and Florham Park, New Jersey, announced that the U.S. Food and Drug Administration (FDA) approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who were about to have a medical procedure performed.
As its acquisition by Takeda Pharmaceutical edges closer and closer, Shire reported a solid second-quarter.
Only a matter of days after Roche filed its second-quarter financial report, it’s had plenty of news to report.
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.
The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
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).
Shares of AbbVie are up slightly this morning after the company announced that it finally received regulatory approval for its endometriosis drug elagolix. The approval marks the first new approved oral treatment for endometriosis-associated pain in more than 10 years.
GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.
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