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This approval will provide significant additional capacity to address patients' needs across markets in Europe, the company said in a statement.
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The startup’s captable boasts of former Meta COO Sheryl Sandberg, Yahoo co-founder Jerry Yang among its angels, apart from a slew of institutional investors like Accel, Prosus and Wipro.
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Ema also has Yahoo founder Jerry Yang and former Facebook COO Sheryl Sandberg, Ribbit Capital’s Micky Malka among others as angel investors.
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More travel updates: Up to $3,000 fine for not wearing a mask in the US, Australia may allow fully vaccinated travellers by Christmas, and Italy recognises all versions of AstraZeneca vaccine now.
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EMA pointed to a list of six current approved manufacturing sites for Vaxzevria in Belgium, US, UK, Netherlands, South Korea and China – that does not include India.
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The Centre has now announced it will fast-track approval to foreign drug companies whose Covid-19 vaccines have already been approved by the drug certification agencies of the United States, United Kingdom, Japan, European Union and the World Health Organization. But that does not mean the number of steps to vet the vaccine or the requirements for it to be commercially sold has been reduced. We detail the exact process that will determine how long it will take for foreign vaccines to be jabbed in the arms of Indians.
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The decision, announced by the European Medicines Agency (EMA) on its website, is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent year
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Following are the top picks from Reliance Securities.
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Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
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Biotech company, Biocon will see two crucial inspections later this month and in early April. Company‘s manufacturing sites will come up for inspections by the European medicines agency later this month and next will be an inspection by the US FDA.
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Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
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The European Medicines Agency (EMA) has accepted to review Mylan and Biocon‘s application for a biosimilar called Trastuzumab, used for certain breast and gastric cancers.
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This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe, global pharma major Mylan and Biocon said in a statement today.
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Alkem informed exchanges that the company will be submitting a suitable clarifications to the European Medicines Agency within the stipulated timelines to enable the Committee for Medicinal Products for Human Use (CHMP) take a balanced risk-benefit view with respect to these two products.
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The medicines are now being reviewed by the European Medicines Agency (EMA) on the recommendation of the German regulator, which inspected Alkem's Taloja plant in western India last March.
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The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences.
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The world's first malaria vaccine got a green light on Friday from European drugs regulators who recommended it should be licensed for use in babies in Africa at risk of the mosquito-borne disease.
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German drug regulator has welcomed the European Medicine Agency's (EMA) decision to suspend the marketing authorisation of around 700 generic drugs subjected to clinical trials by India's GVK Biosciences.
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Riverbed Performance Management solutions deliver a unique combination of end-user experience monitoring, transaction tracing, deep component monitoring, and IT infra management.
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Geojit Comtrade has come out with its report on agricultural commodities. The research firm has recommended to sell Castorseed, RMSeed on pullback and buy CPO on dips in its report dated January 17, 2013.
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In an interview with CNBC-TV18, Anil Manghnani of Modern Shares & Stock Brokers, spoke about his reading of the market and his outlook.
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Geojit Comtrade has come out with its report on agricultural commodities. The research firm has recommended to buy Jeera, Turmeric on dip and sell RM Seed on pullback in its report dated December 12, 2012.
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Geojit Comtrade has come out with its report on agricultural commodities. The research firm has recommended to sell Castorseed on pullback; Wheat below Rs 1510, Maize below Rs 1475, in its report dated September 04, 2012.
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India Forex has come out with its technical outlook on Gold and Crude.
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ICICIdirect.com has come out with its report on Nifty Future, Tata Motors, HCL Technology, ITC and Hindustan Zinc
