Laurus Labs gets 2 USFDA observations for Visakhapatnam facility Farhat Nasim10 Nov 2019 10:00 AM ISTNew Delhi: Drug firm, Laurus Labs Ltd. recently said in a filing that the US health regulator has issued two observations after the inspection of its...
Aurobindo Pharma USA recalls heartburn drug Ranitidine over cancer causing impurities Medical Dialogues Bureau10 Nov 2019 9:45 AM ISTAurobindo Pharma is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported...
Sun Pharma reports net profit of Rs 1064 crore in Q2 Medical Dialogues Bureau10 Nov 2019 9:30 AM ISTTotal revenue from operations during the period under review stood at Rs 8,123.35 crore as against Rs 6,937.63 crore in the year-ago quarter, said Sun...
Abbott discovers new strain of HIV, keeping global health community step ahead of virus Medical Dialogues Bureau10 Nov 2019 9:00 AM ISTNew Delhi: Abbott announced recently that a team of its scientists identified a new subtype of the human immunodeficiency virus (HIV), called HIV-1...
Biogen to commercialize Samsung Bioepis 2 new ophthalmology biosimilars Lucentis, Eylea in major markets worldwide Medical Dialogues Bureau10 Nov 2019 8:59 AM ISTUnder the terms of the proposed transaction, Biogen will make a $100 million upfront payment to Samsung Bioepis. Additionally, Biogen may pay Samsung...
Lupin gets USFDA nod for generic equivalent of Zyflo CR Extended-Release Tablets to treat prophylaxis, asthma Farhat Nasim9 Nov 2019 2:39 PM IST"Zileuton Extended-Release Tablets, 600 mg are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age...
Strides Pharma Ranitidine relaunched in US citing acceptable NDMA limits Medical Dialogues Bureau9 Nov 2019 9:45 AM IST"Strides' Ranitidine tablets 300 mg were within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm. Strides Pharma has now completed...
AstraZeneca CKD anaemia drug Roxadustat shows increased haemoglobin levels in Phase 3 trial Medical Dialogues Bureau9 Nov 2019 9:15 AM ISTNew Delhi: AstraZeneca recently presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that Roxadustat significantly...
Crescita Therapeutics gets USFDA nod for Enhanced Formulation of Pliaglis Medical Dialogues Bureau9 Nov 2019 9:15 AM ISTNew Delhi: Crescita Therapeutics Inc. ("Crescita"), a commercial dermatology company with manufacturing capabilities and a portfolio of...
Shilpa Medicare gets USFDA approval for generic equivalent of cancer drug TARCEVA Farhat Nasim8 Nov 2019 10:00 AM ISTErlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with...
Johnson and Johnson seeks European Medicines Agency nod for Ebola Vaccine Medical Dialogues Bureau8 Nov 2019 9:45 AM ISTJnJ said it submitted two marketing authorization applications to the European Medicines Agency (EMA) for its vaccine regimen targeting the Zaire...
Penalty levied by SEBI on Jubilant Life Sciences reduced to Rs 5 lakh Medical Dialogues Bureau8 Nov 2019 9:30 AM IST"We have found that the appellant in... Jubilant Life Sciences would be liable for a penalty only on one count i.e. for non-disclosure of the China...