Drug Approval | August 20, 2022
Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Therapy recently approved in Canada under the brand name KORSUVA
Therapy recently approved in Canada under the brand name KORSUVA
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
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
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
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
Collaboration supports multiple discovery efforts, including vaccines
The card-to-cloud device was launched into the U.S. and many other markets and is designed to work without an embedded communications module.
The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
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