Proceeds from the proposed issue will be utilized to part finance Balaxi’s planned EU GMP-compliant manufacturing facility for Oral Solid Dosages and Liquid Injectables at TSIIC Pharma Formulations SEZ
Phase 2 study to assess efficacy and safety of once daily linperlisib in patients with advanced peripheral T/NK cell lymphoma
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
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