• Astex Pharmaceuticals Inc., of Dublin, Calif., said it plans to submit an investigational new drug application to the FDA for ASTX727, an oral hypomethylating agent (HMA) in the fourth quarter. The product is intended as a fixed-dose oral combination product consisting of decitabine and E7727, a cytidine deaminase inhibitor (CDAi) licensed from Eisai Inc., of Woodcliff Lake, N.J., CDA is responsible for the degradation of nucleosides, including decitabine and azacitidine. High levels of CDA in the gastrointestinal tract and liver rapidly degrade those nucleosides and prohibit or limit their oral bioavailability.

• Boehringer Ingelheim Pharmaceuticals GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, jointly announced that their marketing authorization application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of Type I and Type II diabetes, has been accepted for review by the European Medicines Agency (EMA). LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.

• GW Pharmaceuticals plc, of Porton Down, UK, said its cannabinoid product Sativex, for use in the treatment of moderate to severe spasticity in multiple sclerosis, is now available in Italy through its partner Almirall S.A., of Barcelona, Spain. The launch follows receipt of full marketing authorization for the product by the Italian health authorities in May. (See BioWorld Today, May 15, 2013.)

• Mylan Inc., of Pittsburgh, said the U.S. District Court for the Southern District of New York has issued a final judgment and order following a ruling by the Court of Appeals for the Federal Circuit in favor of Mylan Specialty L.P., (formerly known as Dey Pharma L.P.) that five of its patents related to its Perforomist inhalation solution are valid and enforceable. In addition, the order stated that chronic obstructive pulmonary disease drug Brovana (arformoterol tartrate), a product from Sunovion Pharmaceuticals Inc., of Marlborough, Mass., infringes each of those patents. Mylan previously announced a settlement agreement with Sunovion resolving the litigation relating to Brovana. Under the agreement, accepted by the U.S. District Court for the Southern District of New York, Sunovion acknowledged that Brovana infringes two valid and enforceable Mylan patents that expire June 22, 2021. (See BioWorld Today, May 29, 2012.)