Drug Approval | August 27, 2021
Indoco’s AnaCipher receives UK-MHRA accreditation
The clinical research organisation located in Hyderabad is a USFDA inspected facility
The clinical research organisation located in Hyderabad is a USFDA inspected facility
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
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.
Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease
The acquisition was expected to be completed in eight weeks, and it would have provided it with a foothold in the US $ 48 billion global animal health market
FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
TAH is now undergoing regulatory clearance and final quality control procedures for the swab deployment in India, EU, Singapore, UK, US, Australia and others for COVID-19 testing
India’s dependency on China for pharma intermediates can change if there is a proper coordination between educational institutes, research institutes and pharma manufacturers
Lenalidomide is used to treat cancer and also some anaemia disorders
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