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BIOLOGIC LICENSE APPLICATION
USFDA issues CRL for proposed biosimilar Insulin-R: BioconThe CRL cites additional data required in the BLA submission and an expectation of satisfactory implementation of a corrective and preventi...07 Jan, 2023, 03.38 PM IST- Drug maker Lupin inks licensing pact with Axantia for PegfilgrastimPegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherap...01 Feb, 2022, 01.43 PM IST
- Bharat Biotech to conduct Covaxin clinical trials in USThe US partner for Bharat Biotech’s Covid-19 vaccine, Ocugen, said that it would pursue submission of a Biologics License Application (BLA)...12 Jun, 2021, 07.20 AM IST
- No impact of USFDA move on Covaxin in India: VK PaulPaul said that every country has its own benchmarks, and welcomed the USFDA’s decision to ask Bharat Biotech to apply for a full Biologics ...12 Jun, 2021, 07.11 AM IST
- FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech"No vaccine manufactured or developed in India has ever received Emergency Use Authorisation or full licensure form the USFDA,” it said in ...11 Jun, 2021, 02.01 PM IST
- Biocon tanks 4% as USFDA defers decision on Avastin biosimilar applicationBiocon's arm Biocon Biologics and Mylan, a subsidiary of Viatris Inc, have been informed by the USFDA of a deferred action on the BLA for M...28 Dec, 2020, 09.56 AM IST
- USFDA informs Biocon Biologics, Mylan of deferred action on Avastin biosimilar license application"To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard revie...25 Dec, 2020, 01.55 PM IST
- US FDA accepts Biocon's cancer drug application for reviewBiocon and Mylan’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for ...09 Mar, 2020, 10.13 AM IST
- Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licenceThis additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its...27 Nov, 2019, 05.22 PM IST
- USFDA issues CRL for proposed biosimilar Pegfilgrastim: BioconThe company said it does not expect the CRL to impact the timing of the launch of biosimilar Pegfilgrastim in the US market.10 Oct, 2017, 02.19 PM IST
- Biocon gets CRL from USFDA for anti-cancer drugThe company, however, said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US.10 Oct, 2017, 11.59 AM IST
- Dr Reddy's may file two new drugs with FDA by 2019The city-based pharma company is expected to file the New Drug Application (NDA)with US Food and Drug Administration with regard the migrai...20 Jun, 2017, 03.00 PM IST
- Biocon Q3 net up 65% to Rs 171.3 croreThe company had posted a net profit after taxes, minority interest and share of profit from associates of Rs 104.1cr for the corresponding ...24 Jan, 2017, 11.03 PM IST
- Glenmark Pharma draws up capex of USD 300 mn over next 3 yearsGlenmark along with its subsidiaries operate 17 manufacturing facilities across four countries and has five research and development center...19 Dec, 2016, 11.03 PM IST
- Glenmark gets licence for chronic pain treatment from LLGGlenmark Pharmaceuticals said it has received exclusive license to the entire IP of Lay Line Genomics for a specific process for treating c...06 Oct, 2010, 03.53 PM IST
- Zenotech to invest over Rs 90 cr in R&DGeneric biopharmaceutical company Zenotech Laboratories is set to invest over Rs 90 crore to strengthen its R&D pipeline.25 Oct, 2007, 03.49 AM IST
- Zenotech plans to invest over Rs 90 crore in R&DHyderabad-based generic biopharmaceutical company Zenotech Laboratories is set to invest over Rs 90 crore to strengthen its R&D pipeline.24 Oct, 2007, 01.49 AM IST
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