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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


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


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


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
Drug Approval | August 27, 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials


SEC recommends Phase I clinical trials for Reliance’s Covid-19 vaccine candidate
News | August 27, 2021

SEC recommends Phase I clinical trials for Reliance’s Covid-19 vaccine candidate

The company has to approach the DCGI for approval to commence the trials


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


Pharma continues to attract PE investments: Care Ratings
News | August 27, 2021

Pharma continues to attract PE investments: Care Ratings

In H1FY21, it attracted PE deals worth US $ 1.6 billion compared to US $ 3 billion in CY2020


Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin
Drug Approval | August 26, 2021

Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin

The company to receive upfront and milestone payments, in addition to royalties