US FDA accepts Mylan’s BLA for proposed trastuzumab product
Biocon and Mylan have announced acceptance of the latter’s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. Mylan’s MYL-1401O is indicated to treat certain HER2-positive breast cancers.Nearly two million women across the globe are diagnosed with breast cancer every year. Mylan has exclusive commercialisation rights for this product in the US, Canada, Japan, Australia, New Zealand and the European Union and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan in the remaining parts of the world.
Merck’s Keytruda takes combo lead with surprise FDA filing
Merck & Co.’s immunotherapy drug Keytruda is yet another step closer to eclipsing its competitors in lung cancer. In an out-of-the-blue announcement, the U.S.-based drugmaker said the FDA had accepted its application for a new Keytruda-plus-chemotherapy combo use that could expand its market considerably, and was granted priority review to boot. Merck had previously unveiled some impressive study data on the chemo combo approach, and Merck’s application is based on data from the Keynote-021 trial, and, if approved, would be Keytruda’s first in combination with another drug.
M Pharmaceutical to develop new topical drug product for FSD
Canadian-headquartered M Pharmaceutical has announced its plan to continue advancing the development of a topical drug product as part of its planned acquisition of 40 J’s. The drug will be used for the treatment of female sexual dysfunction (FSD). According to the company’s CEO, this topical drug product would focus on women with orgasm and arousal difficulties. The company’s proposed treatment is topical, local and non-systemic, while being non-hormonal and is not a central nervous system drug.
Merck KGaA to Deploy Palantir Data Analytics
Merck KGaA has partnered with Palantir Technologies, a developer of data integration and analysis software, headquartered in Palo Alto, CA. The partnership will leverage Palantir’s data analytics capabilities to help Merck KGaA rapidly develop and commercialize new products and improve patient outcomes. Initially, Merck KGaA will apply the technology to cancer treatment and patient services and then across all three of its business sectors: Healthcare, Life Science and Performance Materials. The partnership aims to increase precision of the drug development process by developing a collaborative data and analytics platform so that researchers can analyze real-world and bioinformatics data to understand the patients who may benefit most.