Showing posts from May, 2018

Sun Pharma gets USFDA nod for prostate cancer drug

Drug major Sun Pharmaceutical IndustriesNSE 2.34 %' subsidiary has received approval from the US health regulator for YONSA, used for treatment of a form of prostate cancer.  Sun Pharma had acquired YONSA from Churchill Pharmaceuticals and will commercialise the drug in the US.  In a regulatory filing, Sun Pharma and Churchill Pharmaceuticals, LLC said "one of Sun Pharma's wholly owned subsidiary companies has received approval from the US Food and Drug Administration (USFDA)   for YONSA." YONSA (abiraterone acetate) is a novel formulation in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), the company said.  Sun Pharma said Churchill is eligible to receive upfront and sales-linked milestone payments as well as royalties on sales pursuant to an agreement between the two companies to commercialise YONSA in the US.  YONSA in combination with methylprednisolone was filed as a new drug  appl

Roche wins reprieve as Novartis biosimilar delayed in U.S.

  Roche  has won a reprieve from an expected wave of cheaper versions of its biotech cancer drugs as U.S. regulators knocked back a biosimilar form of  rituximab  from Swiss rival  Novartis . Novartis's  Sandoz unit  said its copy of Roche blockbuster Rituxan -- used to treat blood cancers and certain immunological diseases -- had received a so-called complete response letter from the U.S. Food and Drug Administration (FDA). The FDA issues such letters when it is not ready to approve a product. The news follows a similar setback for another biosimilar copy of Rituxan from Celltrion and its partner Teva. Together, the two delays win Roche extra breathing space in the crucial U.S. market. Roche shares rose nearly 2 percent by 0840 GMT while Novartis stock was little changed. Deutsche Bank analyst Tim Race said Rituxan could now remain free from biosimilar competitors in the United States this year, with erosion threatening only from 2019. Rituxan generates about $4 bill