Agile birth control patch Twirla USFDA review delayed by 3 months, shares slide Medical Dialogues Bureau17 Nov 2019 9:25 AM ISTTwirla, a once-weekly contraceptive patch made from a combination of hormones Ethinyl estradiol and levonorgestrel, was backed by a panel of...
BeiGene gets USFDA approval for lymphoma drug Brukinsa Medical Dialogues Bureau17 Nov 2019 9:20 AM ISTBeiGene tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21%...
Expanding use of Amarin heart drug Vascepa unanimously backed by USFDA panel Medical Dialogues Bureau17 Nov 2019 9:15 AM ISTThe USFDA panel voted 16-0 in favour of expanding approval, potentially opening up a multi-billion dollar opportunity for Amarin which has only one...
Cipla gets 4 USFDA observations for Patalganga facility Medical Dialogues Bureau16 Nov 2019 12:56 PM ISTNew Delhi: Drug maker Cipla recently informed that the United States Food and Drug Administration (USFDA) conducted a routine cGMP (current Good...
Cadila Healthcare Moraiya plant gets USFDA warning letter for significant violations of CGMP Medical Dialogues Bureau16 Nov 2019 11:11 AM ISTCadila Healthcare failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at...
Natco Pharma Vizag facility begins production Medical Dialogues Bureau16 Nov 2019 9:35 AM ISTThe Visakhapatnam facility was a part of the Special Economic Zone (SEZ) and intended to cater primarily to the U.S. and other international markets,...
Bharat Biotech arm Chiron Behring relaunches rabies vaccine as Chirorab Medical Dialogues Bureau16 Nov 2019 9:30 AM ISTThe immunogenicity, efficacy, and safety of Chirorab has been assessed in several clinical trials in pre- and post-exposure regimens, using both...
Mylan, Pfizer say Mylan-Upjohn combined entity to be known as Viatris Medical Dialogues Bureau16 Nov 2019 9:20 AM ISTNew Delhi: Mylan N.V. and Pfizer Inc. recently announced that the name of the new company to be formed by the planned combination of Mylan and Upjohn,...
Metropolis Healthcare Q2 profit up 44 pc to Rs 43 crore Medical Dialogues Bureau16 Nov 2019 9:15 AM ISTThe profit after tax works out to Rs 43 crore in Q2 FY20, up 43.7 per cent from Rs 30 crore in Q2 FY19.Mumbai: Leading diagnostic service provider...
Zydus Cadila acquires 15 pc stake in Zydus Noveltech, Zydus Technologies for over Rs 1 crore Medical Dialogues Bureau15 Nov 2019 3:21 PM ISTNew Delhi: Drugmaker, Zydus Cadila also known as Cadila Healthcare Ltd.(CHL) has recently announced that the company has acquired 15 per cent stake in...
Aurobindo Pharma gets 14 USFDA observations for Pashamylaram facility Farhat Nasim15 Nov 2019 12:13 PM ISTThe US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at...
JB Chemicals Q2 PAT jumps 82 pc at Rs 94 crore Medical Dialogues Bureau15 Nov 2019 9:32 AM ISTMumbai: JB Chemicals and Pharmaceuticals Ltd on Tuesday reported 82 per cent jump in its profit after tax during the second quarter at Rs 94 crore...