Centaur Pharma Ambernath facility receives EIR from USFDA Farhat Nasim28 Nov 2019 9:30 AM ISTCentaur Pharma has now received a formal EIR (Establishment Inspection Report) from USFDA stating the facility is CGMP compliant and the audit outcome...
Pfizer, Novartis lead USD 2 billion spending spree on gene therapy production Medical Dialogues Bureau28 Nov 2019 9:00 AM ISTNew Delhi: Eleven drugmakers led by Pfizer and Novartis have set aside a combined $2 billion to invest in gene therapy manufacturing since 2018,...
Aurobindo Pharma targets to achieve zero debt in three years sans Novartis deal Medical Dialogues Bureau26 Nov 2019 9:30 AM ISTIn September 2018, the USD three billion drug-maker, Aurobindo Pharma said its US subsidiary entered into an agreement to acquire commercial...
Roche anticipates USFDA nod for SMA drug Risdiplam by early 2020 Medical Dialogues Bureau26 Nov 2019 9:28 AM ISTRoche, whose drug Risdiplam is seen as a rival for Biogen's Spinraza and Novartis's Zolgensma gene therapy, said the FDA is due to decide by May 24....
AstraZeneca leukemia drug Calquence gets USFDA okay Medical Dialogues Bureau24 Nov 2019 10:00 AM ISTNew Delhi: AstraZeneca said late on Thursday that the U.S. Food and Drug Administration (FDA) had given its go-ahead for the company's Calquence drug...
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%...
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,...
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...
Aurobindo Pharma Q2 net profit up by 5 pc to Rs 640 crore Medical Dialogues Bureau14 Nov 2019 9:30 AM ISTManaging director of Aurobindo Pharma N Govindarajan said We had another quarter of healthy performance where we continued to grow in the US and...
RedHill Biopharma Talicia wins USFDA nod for treating bacterial infection Medical Dialogues Bureau11 Nov 2019 9:15 AM ISTThe drug, Talicia, is an oral capsule comprising two antibiotics, amoxicillin and rifabutin, as well as omeprazole, a common treatment for...
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...
