Drug Approval | June 23, 2022
Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
Sanjay Verma of Akums Drugs & Pharmaceuticals, Manu Gupta of Cadila Pharmaceuticals, Rahul Borse of RPG Life Sciences, Krishna Sai T of Biocon and Amit Saluja of NASSCOM are speakers
The company is strategically expanding its product portfolio with a pipeline of new products that will form a strong foundation for future growth.
V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019
Guindo will be responsible for leading the development and implementation of the company’s long-term strategy for the Human Health portfolio.
The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.
Bringing next-gen cannabinoid therapeutics to cancer patients
The company is now introducing the product into the India pharmaceutical market.
The company has a total sales of Rs. 25.8 crore during FY 21-22 and Rs. 26.4 crore during FY 20-21.
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