The FDA on Feb. 4 issued an emergency use authorization (EUA) to enable emergency use of the CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, that test has been limited to use at CDC laboratories; the new authorization allows the use of the test at any CDC-qualified lab across the country. “This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen M. Hahn. The 2019-nCoV virus, identified in Wuhan, China, in December, is a new type of coronavirus that can cause severe respiratory illness in humans. Most patients with confirmed 2019-nCoV infection have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with 2019-nCoV infection. Under the EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests.
United Therapeutics Corp., of Silver Spring, Md., said on Jan. 29 the U.S. District court for the District of New Jersey issued a decision in favor of the company and Smiths Medical ASD Inc., denying the request for preliminary injunction sought by Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG, and Raregen LLC in pending antitrust litigation. According to the court, "[Sandoz and Raregen] have not met their burden of demonstrating a reasonable probability of eventual success in the litigation." The unsealed opinion was just released by the court, the company said. United and Smiths Medical were named as defendants in a lawsuit filed in federal court on April 16, 2019, alleging that United engaged in anticompetitive conduct in connection with efforts by Sandoz and Raregen to launch their generic version of pulmonary arterial hypertension drug Remodulin (treprostinil) injection. Remodulin, which is delivered either subcutaneously or intravenously with a pump, posted sales of $599 million for 2018. Shares of United (NASDAQ:UTHR) gained 5% to close Feb. 5 at $101.47.
The U.S. District Court of Central California rejected a motion from the U.S. government against Mark Berman and Elliot Lander, doctors at the California Stem Cell Treatment Center and Cell Surgical Network, specifically denying the government’s request for a permanent injunction against the use of fat-derived stromal vascular fraction (SVF). The physicians offer a medical treatment during which fat tissue is removed from a patient, SVF stem cells are isolated and implanted back into the same patient. The government alleged the SVF process does not qualify for the SSP, or same surgical procedure, exception because tissue is removed, but only SVF stem cells are implanted back into the body, therefore resulting in the defendants selling an unregistered drug. Judge Jesus Bernal held that if, in fact, the cells implanted are unaltered during the procedure, the SVF procedure would qualify for the exception. But that issue was not before the court in the government’s motion, and the parties will go to trial. The case is United States of America v. California Stem Cell Treatment Center, Inc., et al.