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CHMP
Dr. Reddy’s Laboratories shares jump over 1% as European Commission approves biosimilar AVT03Dr. Reddy's Laboratories secured European Commission approval for AVT03, a biosimilar to Prolia and Xgeva, for osteoporosis and bone compli...- Biocon biologics receives European Commission approval for Vevzuo, Evfraxy Denosumab biosimilars for bone diseasesBiocon Ltd's arm, Biocon Biologics Ltd, has received European Commission authorisation for its Vevzuo and Evfraxy biosimilars, used to trea...
- Aurobindo Pharma shares in focus after European Commission nod for cancer drug DazublysAurobindo Pharma's subsidiary, CuraTeQ Biologics, secured European Commission approval for its trastuzumab biosimilar, Dazublys, indicated ...
- Stocks in news: Vedanta, Dixon Tech, Bharat Forge, ONGC, RILDixon Technologies and Chinese smartphone maker Vivo are entering into a joint venture that will manufacture smartphones for the smartphone...
- Biocon Biologics' biosimilar human insulin gets backing from EMA expert panelThe EMA's Committee for Medicinal Products for Human Use (CHMP) opinion will be considered by the European Commission. "The European Commis...
- Biocon Biologics, Viatris receive approval for cancer drugAbevmy is approved for treatment in metastatic colorectal carcinoma, metastatic breast cancer, non small-cell lung carcinoma, glioblastoma,...
- Biocon Biologics, Viatris Inc. get CHMP nod for Abevmy, a biosimilar to AvastinAbevmy is abiosimilar to Roche's Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cance...
- Covid has been a bit of a deterrent for creating new markets: Kiran Mazumdar ShawLatest funding in Biocon Biologics is a precursor to the IPO. The initial funding of $300 million plus very important to ensure that we rem...
- EU agency ponders approval for Moderna's COVID-19 vaccineThe meeting of the European Medicines Agency's human medicines committee (CHMP) comes amid high rates of infections in many EU countries an...
- Biocon, Mylan's diabetic drug receives positive opinion from European Medicines AgencyBiocon said the CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is ex...
- Gilead's remdesivir set to become Europe's first COVID-19 therapyThe EMA endorsement means physicians can prescribe the Gilead drug in Europe once the European Commission, the EU executive, gives its appr...
- Lupin gets European Commission nod for myotonia treatment drugLupin said it is preparing for the launch of NaMuscla, which will occur in the initial markets of Germany and the UK in the first quarter o...
- European Medicines Agency suspends scores of drugs tested by Semler ResearchThe bioequivalence studies, necessary to gain approvals - were done by Indian CRO for large generic companies including Mylan Teva, Accord ...
- Pfizer may leverage European approval to pneumonia vaccine in Indian marketNew York-headquartered pharmaceutical giant is likely to leverage its latest European approval for multi-dose vials of pneumococcal vaccine...
- EU bans 700 generic drugs for manipulation of trials by GVK BiosciencesMedicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...
- EU regulator recommends suspension of drugs over GVK Bio dataThe recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on be...
- Four European Union countries suspend authorisation of 25 drugs studied at GVK BiosciencesEuropean Medicines Agency (EMA) said in a statement that it is reviewing findings of non-compliance with good clinical practise at the GVK ...
- European Union health regulators suspect manipulation by GVK BioRegulators in many European countries including Germany are reportedly evaluating whether to suspend the use of over 100 medicines.
- Europe backs new dual-action Novartis lung drugNovartis won an important endorsement of its new medicine for chronic lung disease when European regulators recommended approval of Ultibro...
- Biotech cos eye Canada, US marketBiotechnology companies in the country have something to look forward to over the next few months. Health Canada, Canada’s health regulator...
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