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BIOLOGICS LICENSE APPLICATION
For both the compulsive trader and careful investor: 25 stocks to watch if risk appetite returns; some with upside potential, some notIf the price of crude oil softens, Indian equities may again see a risk-on phase. Tariff concerns are no longer the central issue; the larg...- Biocon Biologics gets US nod to launch Stelara biosimilarBiocon Biologics has secured USFDA approval to launch the biosimilar of Janssen's Stelara by February 2025, targeting autoimmune conditions...
- USFDA issues CRL for Bevacizumab license application moved by Viatris: Biocon"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company sp...
- 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...
- 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...
- 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)...
- 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 ...
- 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 ...
- 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...
- 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...
- 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 ...
- 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...
- 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.
- 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.
- 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...
- 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 ...
- 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...
- 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...
- 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.
- 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.
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