How Kyprolis Overcame Serious Safety Fears To Reach Myeloma Market With Clean Label
FDA had flagged life-threatening safety issues that could have delayed approval of Onyx’s myeloma drug Kyprolis. But in the end, the agency instead opted for explicit instructions in the label to avoid risks, stopping short of a boxed warning, and a sub-study in a Phase III trial to fully assess cardiac and pulmonary risks.
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The big biotech is prepared to launch its newly approved leukemia drug blinatumomab through its Onyx subsidiary in a matter of weeks, despite the rapid approval timeline.
Third Quarter Earnings Briefs: Lilly, Bristol, Shire, Biomarin, Alexion
Lilly lowers expectations for Cymbalta; Celgene’s Abraxane continues with strong sales; Bristol touts the potential of Eliquis and Bydureon, despite slow sales; Ornskov discusses One Shire plan; BioMarin readies fifth compound for the clinic, and more.
Amgen Wins Onyx, But Will The Deal Pave The Road To Transformation?
The addition of Onyx’s cancer drugs to Amgen’s portfolio will fill a near-term sales gap for the big biotech and reinforce the company as a major oncology player. But Amgen will need to execute expertly on the merger if it is to transform itself into a high-growth biotech.