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BIOLOGICS LICENCE APPLICATION
New drugs could reach market sooner as govt halves trial review timelineThe Indian government is shaking up the pharmaceutical sector by slashing the review period for manufacturing applications for new drugs to...- Biocon settles with Janssen to commercialise biosimilar products in Europe, Canada, JapanBiocon Biologics has entered into a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & John...
- Alvotech, Dr. Reddy's ink pact for commercialisation of denosumabAlvotech and Dr. Reddy's partner for AVT03, a biosimilar to Prolia and Xgeva, treating osteoporosis and skeletal-related events. The agreem...
- Dr Reddy's application for biosimilar candidate accepted for review by USFDARituximab is used to treat certain autoimmune diseases and types of cancer. "This milestone underscores our capability for global clinical ...
- 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...
- Bharat Biotech's US partner Ocugen files request with FDA for Covaxin trialsThe US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experience...
- Approval to Covishield would be considered should we receive marketing authorisation application: EU agencyThe EU Digital COVID certificate or 'Green Pass' will be mandatory to travel to European countries and the document is likely to serve as p...
- America denying EUA to Covaxin won't impact India's vaccine programme, says governmentResponding to a question on the denial to Covaxin, NITI Aayog member (Health) V K Paul said each country has its own regulatory system whic...
- FDA rejects EUA for Covaxin, 'suggests' Biologics Licence Application route for approval in USOcugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA...
- Bharat Biotech's partner seeks full approval for Covaxin in USThis follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to ...
- J&J awaiting DCGI nod for bridging trial of one-dose jabIt is unclear why J&J wants to conduct a bridging trial in India despite regulations in India allowing easy access to vaccines that have re...
- J&J seeks permission for phase-3 trial of its single-shot COVID vaccine in India, import licenceThis comes close to the heels of the central government last week deciding to fast-track emergency approvals for all foreign produced coron...
- High-level government panel suggests single-window system for new drug approvalsThe committee, set up by the cabinet secretary after Prime Minister Narendra Modi sought overhauling of the country’s drug regulatory syste...
- Aurobindo Pharma to launch oncology, respiratory products in US by 2021The company is also focussing on securing intellectual property (IP) and ramping up and filing of specialty products.
- US FDA accepts application for psoriasis drug: Sun PharmaThe FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March ...
- USFDA accepts Mylan's BLA for proposed biosimilar PegfilgrastimThe proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the ...
- Norms eased for makers of biologic productsCDSCO has done away with the need for joint inspections to issue licences to allow such companies to make biologic products for testing and...
- Mylan and Biocon make USFDA submission for proposed biosimilar trastuzumabThe submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data that consists of two pharmacokin...
- Directorate General of Foreign Trade unveils norms for human bio samples tradeIn a separate trade notice, DGFT said that grapes packed in imported material do not fall under ineligible category under a norm of the for...
- DIPP may seek information from DCGI to manufacture generic version of Roche's anti-cancer drugWorried over the exorbitant prices of the drug in the Indian market, the ministry urged the DIPP to invoke this section.
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