Pharma News

The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

Teva Pharmaceutical Industries Ltd announced the exclusive launch of a generic version of Reyataz®1 (atazanavir) capsules in the U.S.

Lupin announced that it has received final approval for its Calcipotriene Topical Solution, 0.005% (Scalp Solution) from the United States Food and Drug Administration (FDA) to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.

Rhizen  Pharmaceuticals S.A., an nounced  that the U.S. Food and Drug Administration  (FDA) has granted orphan - drug designation for  the active moiety of Tenalisib  (RP6530),  the Company’s  highly selective and orally active  dual PI3K delta/gamma  inhibitor, for treatment of  peripheral T - cell l ymphoma  (PTCL).

Dr. Reddy’s Laboratories Ltd that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran® (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA).

Roche and Ignyta, Inc have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.

Allergan plc a leading global pharmaceutical company, announced that the United States Court of Appeals for the Federal Circuit affirmed the United States District Court for the Eastern District of Texas' earlier decision that that each of three Allergan patents (U.S. Patent Nos. 7,030,149, 7,320,976 and 8,748,425) that are listed in the Orange Book for COMBIGAN® is valid. The Federal Circuit also affirmed the district court's finding that Sandoz' proposed generic version of COMBIGAN® does not infringe the '149 and '976 patents, and reversed the district court's decision that Sandoz' proposed generic product infringes the '425 patent.

AMAG Pharmaceuticals, Inc announced the issuance of U.S. Patent Number 9,844,558 entitled “Methods of Reducing Risk of Preterm Birth.” This newly issued patent is directed to subcutaneous administration and dosing of Makena® (hydroxyprogesterone caproate injection) and is expected to expire on May 2, 2036. Makena is a treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.

Suven Life Sciences Ltd (Suven) granted of one product patent from Canada (2932428) and one product patent from India (289123) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2034 and 2028 respectively.