Feb 17, 2017 at 15:29 | Source: Moneycontrol.com
Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
Feb 17, 2017 at 14:50 | Source: PTI
US health regulator USFDA hasaccepted pharma major Mylan's biologics licence application(BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim,Biocon and Mylan have said.
Feb 17, 2017 at 09:51 | Source: CNBC-TV18
Biocon Thursday announced the US Food and Drug Administration has accepted Mylans Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
Feb 03, 2017 at 18:24 | Source: PTI
Pharma major Lupin today said it has received final approval from the US health regulator to market its generic version of Mylan's triamcinolone acetonide cream used for treatment of skin disease.
Feb 03, 2017 at 16:00 | Source: Moneycontrol.com
Lupin has received final approval for its Triamcinolone Acetonide cream USP, 0.025 percent, 0.1 percent and 0.5 percent from the United States Food and Drug Administration to market a generic equivalent of Mylan Pharmaceuticals Incs Triamcinolone Acetonide cream.
Jan 31, 2017 at 18:45 | Source: Moneycontrol.com
Natco and Mylan believe that they are the first companies to have filed a substantially complete abbreviated new drug application containing a Para-IV certification for a 3 times per week Glatiramer Acetate Injection 40 mg/mL, and expect 180 days of marketing exclusivity in the US.
Jan 31, 2017 at 11:14 | Source: PTI
"The United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents related to Copaxone 40 mg/mL invalid based on obviousness," Natco Pharma said in a BSE filing.
Jan 31, 2017 at 11:13 | Source: Moneycontrol.com
Natco Pharma announced that the United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone 40 mg/ml invalid based on obviousness.
Jan 31, 2017 at 08:22 | Source: Reuters
The Federal Trade Commission had asked the company for information months ago as part of a preliminary investigation, a company spokesperson said in an email.
Jan 25, 2017 at 11:02 | Source: CNBC-TV18
Attributing the strong show in Q3FY17 to robust performance in biologics, Biocon Chairperson and MD Kiran Mazumdar-Shaw told CNBC-TV18 that Biocon is well poised to be front-runner in biosimilars. The acceptance of biosimilar Trastuzumab by the USFDA is a huge milestone for Mylan and Biocon, she said.