News about Manufacturing

Abbott announces CE mark approval for its COVID-19 laboratory based antibody test in India

Abbott announced that it received CE Mark to the IVD Directive (98/79/EC) for its laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19)

Manufacturing | 05/05/2020 | By Darshana |  384

Roche's COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets

Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark2 as well as the U.S.

Manufacturing | 04/05/2020 | By Darshana |  468

Sanofi & GSK ink collaboration to develop unprecedented vaccine for COVID-19

Sanofi and GSK announced that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic

Manufacturing | 16/04/2020 | By Darshana |  381

ICMR approves Molbio Diagnostics' testing kit for COVID-19

Molbio Diagnostics supported by India Health Fund, through the Centre for Health Research and Innovations (CHRI), has recently obtained approval from Indian Council of Medical Research (ICMR) for its testing kit -- the Truenat Beta CoV test -- to be used by patients to test for COVID-19

Manufacturing | 07/04/2020 | By Darshana |  404

Lincoln Pharma continues to invest in upgrading manufacturing capacity

Lincoln Pharmaceuticals Ltd continues to invest in upgrading manufacturing capacity, new product development and expand global footprints

Manufacturing | 06/04/2020 | By Darshana |  357

Lupin's Aurangabad Facility Receives EIR from U.S. FDA

Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad, India facility. The inspection for the facility was carried out by the U.S. FDA between February 10, 2020 and February 14, 2020 and concluded with no observations

Manufacturing | 03/04/2020 | By Darshana |  1474

COVID-19 Testing Kits: Mylab Signs Deal With Serum

Mylab Discovery Solutions, the first Indian company whose testing kit was approved by the Indian Council of Medical Research (ICMR), has tied up with Serum Institute of India, world's largest vaccine manufacturer by number of doses produced, to scale up the operations and escalate faster delivery of testing kits

Manufacturing | 02/04/2020 | By Darshana |  667

Lupin launches Betamethasone Dipropionate Ointment USP (Augmented)

Pharma major Lupin Limited (Lupin) announced the launch of Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin’s Pithampur (Unit III) facility, India

Manufacturing | 21/03/2020 | By Darshana |  1138

BELLUS Health Announces Completion of Enrollment in Phase 2 RELIEF Trial of BLU-5937 for the Treatment of Refractory Chronic Cough

BELLUS Health Inc, a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that it has completed patient enrollment for the RELIEF trial, its dose-escalation, placebo-controlled Phase 2 trial of BLU-5937 in patients

Manufacturing | 21/03/2020 | By Darshana |  717

Medivir and Tango Therapeutics sign license agreement for preclinical asset

Medivir today announced that it has entered into a license agreement with US biotech company Tango Therapeutics for one of Medivir’s preclinical research programs

Manufacturing | 17/03/2020 | By Darshana |  293