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January 27, 2014
08:04 EDTHRTXHeron sees one-quarter delay to timeline for Sustol NDA resubmission
Heron Therapeutics announced an approximate one-quarter delay to the company’s timeline for the resubmission of the new drug application for Sustol to the U.S. Food and Drug Administration, the company’s product candidate for chemotherapy-induced nausea and vomiting. The company received notice last week from the supplier of the syringes used for Sustol injections that the production order of syringes manufactured for Heron, and scheduled to be used in the validation of the commercial manufacturing process for Sustol required for resubmission of the NDA, will be delayed due to equipment failure of an in-process quality control check. The equipment failure is not specific to Sustol or Heron, and remedial efforts are underway. “While the timing of our resubmission will be impacted by this delay, we expect it to have minimal impact on our projected timing of the launch of Sustol,” said Barry D. Quart, PharmD, CEO. “Subject to the FDA’s review and approval of the Sustol NDA, we project being in a position to launch Sustol in early 2015, which presents more optimal timing than potentially launching into the late 2014 holiday season.”
News For HRTX From The Last 14 Days
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July 24, 2015
08:44 EDTHRTXHeron Therapeutics management to meet with Brean Capital
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July 23, 2015
08:08 EDTHRTXHeron Therapeutics initiates second Phase 2 HTX-011 trial
Heron Therapeutics announced that it has initiated a second Phase 2 clinical trial of HTX-011. HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. The placebo-controlled, dose-finding, Phase 2 clinical trial in approximately 60 patients undergoing inguinal hernia repair will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. HTX-011 is also currently being evaluated in a placebo-controlled, dose-finding, Phase 2 clinical trial in patients undergoing bunionectomy. In a previously completed, placebo-controlled, Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam, with therapeutically relevant plasma bupivacaine levels sustained for 2-3 days.
July 20, 2015
08:03 EDTHRTXHeron resubmits SUSTOL NDA to FDA
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