Apr 13, 2017 at 20:59 | Source: PTI
During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.
Mar 03, 2017 at 11:26 | Source: CNBC-TV18
Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
Mar 02, 2017 at 19:00 | Source: PTI
"Once the designated authority has given approval, you cannot say prima facie you have case over that. Till that (approval) is disturbed by an order of the court, it will remain," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said.
Feb 22, 2017 at 20:38 | Source: PTI
The Delhi High Court today told Swiss pharma major Roche that it "cannot hang on to" breast cancer drug Trastuzumab, innovated by it, for the rest of its life after having enjoyed the fruits of its patent.
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.