News | July 21, 2021
EMA grants ODD to Saroglitazar Mg
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
2DG has been given emergency approval by the Drug Controller General of India (DCGI) for use on COVID-19 patients in the country
ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials
Mucormycosis drug AmphoTLC will be imported from Taiwan by Stelis Biopharma Private Limited (Stelis), the biotech arm of Strides group, and will be launched and distributed in India immediately by Strides
Cocktails of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants
The product patent has been already filed under fast track approval
Natco has withdrawn its application filed with the Indian Patent Office, seeking Compulsory License against Lilly for Baricitinib for Covid-19 in India
Proactively engaging with foreign vaccine manufacturers like Moderna, Pfizer etc., to apply for Emergency Use Authorization in India so that these vaccines can be easily imported and made available in India
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.
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