Drug Approval | August 28, 2021
DCGI approves Enzene biosimilar Denosumab for Osteoporosis
This is Enzene Biosciences third biosimilar to be approved
This is Enzene Biosciences third biosimilar to be approved
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
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
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The company has to approach the DCGI for approval to commence the trials
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
In H1FY21, it attracted PE deals worth US $ 1.6 billion compared to US $ 3 billion in CY2020
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
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.
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