Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 235

Results For "trial"

2428 News Found

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options


Indoco’s AnaCipher receives UK-MHRA accreditation
Drug Approval | August 27, 2021

Indoco’s AnaCipher receives UK-MHRA accreditation

The clinical research organisation located in Hyderabad is a USFDA inspected facility


Brazil’s Eurofarma to manufacture Comirnaty for Latin America
Biotech | August 27, 2021

Brazil’s Eurofarma to manufacture Comirnaty for Latin America

The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually


Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Adjuvance announce clinical results of its next-gen saponin adjuvant
Biotech | August 26, 2021

Adjuvance announce clinical results of its next-gen saponin adjuvant

First results demonstrate favourable tolerability of TQL-1055 at all dose levels


Lonza to establish manufacturing facility in Guangzhou, China
News | August 25, 2021

Lonza to establish manufacturing facility in Guangzhou, China

The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services


US FDA approves Medtronic’s TAVR System
Drug Approval | August 25, 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment