Amgen Inc. announced on Wednesday that the Food and Drug Administration has granted priority review to ivabradine, an oral drug for the treatment of chronic heart failure.
The Thousand Oaks biopharmaceutical company has completed Phase III human clinical studies on ivabradine, and in April the drug qualified for “fast-track” status by the FDA, allowing the company to submit its new drug application in parts, known as a “rolling review.”
Priority review is given to applications for new drugs that treat serious conditions and would, if approved, provide significant improvements in safety or effectiveness. For a priority review, the FDA has a goal of making a decision within six months, compared to a year for a regular application.
Shares closed up 56 cents, or less than 1 percent, to $137.83 on the Nasdaq.
Vitesse Semiconductor Corp. has appointed to its board the chairman of its largest shareholder.
William C. Martin is chairman and chief investment officer of Raging Capital Management LLC, in Rocky Hill, N.J. Raging Capital owns more than 14.3 million shares, or 21 percent, in the Camarillo semiconductor maker.
Martin said he was excited to join the board of Vitesse, which is aggressively trying to remake itself as a leading provider of chips for Internet-connected devices.
“Vitesse has made significant progress in executing its strategy to re-position its business with a focus on emerging, high-growth Ethernet-based technologies, and new products now represent the majority of revenue,” said Martin, in a prepared statement.
Shares closed up 16 cents, or more than 5 percent, to $3.21 on the Nasdaq.