Mylan’s Suit Against the FDA Dismissed, Cardica Ships MicroCutter: Healthcare Business Update
The lawsuit brought by Mylan (NASDAQ:MYL) lawsuit against the FDA for withholding approval for the firm to market a generic version of Novartis’ (NYSE:NVS) heart med Diovan, was thrown out by United States District Court Judge John D. Bates in Washington Thursday, who said that the FDA did not behave “capriciously” when it denied Mylan exclusivity to market its version of Diovan, and, the firm failed to show that it suffered “irreparable harm” as a result.
On Thursday, Omeros Corporation (NASDAQ:OMER) announced results from its first pivotal Phase 3 clinical trial evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. In this multicenter, double-blind, Phase 3 clinical trial comparing OMS103HP to vehicle control among 344 subjects, the pre-specified primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score, a patient-reported measure that contains questions about knee swelling, clicking, catching and stiffness. Pain measured in the early postoperative period comprised a pre-specified secondary endpoint. The Symptoms Subscale of the KOOS did not reach statistical significance, but OMS103HP areached a statistically significant (p=0.0003) reduction of postoperative pain.
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Synergy Pharmaceuticals (SGYP) said Thursday that dosing has begun in a Phase IIb clinical trial of plecanatide to treat patients suffering from constipation-predominant irritable bowel syndrome. The trial is being performed at 70 sites throughout the United States, and includes 350 patients with IBS-C who will be treated with one of four doses of plecanatide (0.3, 1.0, 3.0, or 9.0 mg) or placebo, taken once a day during a 12- week period.
Cardica (NASDAQ:CRDC) has shipped its first commercial MicroCutter XCHANGE” 30 devices and cartridges to DACH Medical Group, which serves as its distributor for Germany, Austria and Switzerland. The device is the smallest commercially available, cartridge-based cutting and stapling instrument that is designed to be used during laparoscopic and thoracoscopic surgical procedures.
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