JanOne (JAN +79.2%) spikes after announcing a licensing agreement for its TV1001SR treatment for peripheral artery disease.
JAN says the deal with LSU Health Shreveport, UAB Research Foundation and TheraVasc provides a worldwide, exclusive license for TV1001SR along with a portfolio of 30 patents and other intellectual property relating to the sustained release of sodium nitrite.
The company thinks TV1001SR will be a groundbreaking treatment for patients with PAD, for which there is no known efficacious single-drug treatment and affects more than 200M people worldwide and 8.5M in the U.S.
Teva Pharmaceuticals (TEVA +6.5%) pops higher in morning trade following a Bloomberg report that it has held talks with the U.S. Department of Justice about resolving a criminal antitrust probe of alleged price-fixing by the companies, Bloomberg reports.
A unit of Indian generics giant Sun Pharmaceutical also has been in talks with federal prosecutors, Bloomberg reports.
Among possible outcomes that have been discussed are deferred prosecution agreements in which the companies would admit to certain allegations but would be shielded from indictment in exchange for cooperating with the investigation and paying fines, according to the report.
Prosecutors have been probing allegations that generic drugmakers conspired to prop up the prices of certain widely used medications for more than five years and have hinted several times this year that charges could be imminent.
Seattle Genetics (NASDAQ:SGEN) announces that Health Canada has approved the supplemental new drug submission that expands the use of Adcetris in combination with CHP chemotherapy for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma, peripheral T-cell lymphoma – not otherwise specified or angioimmunoblastic T-cell lymphoma whose tumours express CD30.
The approval is based on positive results of the phase 3 Echelon-2 clinical trial that compared Adcetris plus CHP to CHOP.
Health Canada granted a priority review designation for the submission.
The Health Canada approval of Adcetris in combination with CHP chemotherapy is said to represent the first major advance for Canadian patients with PTCL in decades.
A subsidiary of True Leaf Brands (OTCQX:TRLFF) announces it has secured licenses from Health Canada to cultivate, process and sell cannabis for medical purposes.
The license is for True Leaf’s campus facility in Lumby, British Columbia. The license allows for immediate production from the facility immediately of alternative cannabis products such as edibles, topicals and capsules.
Under Priority Review status, the FDA has accepted Intercept Pharmaceuticals’ (NASDAQ:ICPT) NDA for obeticholic acid (OCA) seeking approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).
PDUFA target action date of March 26, 2020.
In the NDA filing acceptance letter, the FDA also indicated that it currently plans to hold an advisory committee meeting to discuss the application.
Shares are up 5% premarket.
