Genentech,BARDA gets USFDA nod for Actemra Clinical Trial in COVID-19 patients Medical Dialogues Bureau28 March 2020 4:45 AM GMTUS: Genentech, a member of the Roche Group has announced the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind,...
Eli Lilly delays its clinical trials during Coronavirus pandemic Medical Dialogues Bureau25 March 2020 9:30 AM GMTIndianapolis: Eli Lilly and Company has provided an update on the company's clinical trial activities in light of the COVID-19 pandemic. The company...
Another delay in USD 2.1 million gene therapy Zolgensma data reporting, Novartis admits mistake Medical Dialogues Bureau3 Nov 2019 4:15 AM GMTThe USFDA on Wednesday placed a partial hold on a Novartis trial of the $2.1 million-per-patient gene therapy, Zolgensma after the company informed...
Mirati Therapeutics oral drug MRTX849 shrinks tumours in early-stage trial Medical Dialogues Bureau2 Nov 2019 3:30 AM GMTOut of 17 patients enrolled in the Phase 1 trial of Mirati Therapeutics' oral drug MRTX849, 12 have been evaluated, including six with lung cancer and...
CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug Farhat Nasim27 Oct 2019 6:00 AM GMTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker,...
Novo Nordisk Tresiba shows lower risk of hypo in adults with Type 2 Diabetes Medical Dialogues Bureau21 Sep 2019 4:00 AM GMT"We are delighted that the findings of the CONCLUDE trial support what we have seen previously across the Tresiba clinical development programme,"...
Bayer Rivaroxaban tablets win CDSCO Committee nod for waiver of local clinical trial; directed to carry Phase IV trial Medical Dialogues Bureau8 Aug 2019 11:58 AM GMTNew Delhi: The apex drug regulatory body, Central Drugs Standard Control Organisation's (CDSCO) Technical Committee has recommended for grant of...
Zydus Cadila completes phase III trial of Diabetes drug Lipaglyn in India Medical Dialogues Bureau5 Aug 2019 4:30 AM GMTSaroglitazar Magnesium was launched in India during September 2013, under the brand name 'Lipaglyn', for the treatment of hypertriglyceridemia and...
CDSCO mandates filing of online application for veterinary drugs on new SUGAM portal Farhat Nasim1 Aug 2019 5:27 AM GMTNew Delhi: Through a recent notification, the apex drug regulatory body Central Drugs Standard Control Organization (CDSCO) has informed to file...
Dr Reddys yields positive results from phase 2b study of new psoriasis drug Farhat Nasim10 Jun 2019 8:32 AM GMTThe detailed safety and efficacy data from the study would be presented in future dermatology conferences, reads Dr Reddy's (Dr Reddys) recent...
Technical Committee recommends CDSCO to approve import, marketing of Sanofi TB drug with clinical trial waiver Farhat Nasim28 May 2019 10:51 AM GMTNew Delhi: Apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has been recommended by the Techincal Committee to granted...
Sun Pharma submits proposal to CDSCO for manufacturing, marketing FDC to treat URTI; Details Meghna A Singhania25 May 2019 5:45 AM GMTNew Delhi: Dilip Shanghvi led Sun Pharma recently submitted a proposal to seek permission from the national regulatory authority, Central Drugs...