Momenta revises regulatory strategy for proposed Humira biosimilar
Momenta had previously guided that it planned to file a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this
Momenta had previously guided that it planned to file a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this
Zolgensma was previously granted breakthrough therapy designation by the US regulator. Novartis expects a regulatory action to be taken on the gene replacement therapy in May 2019. According
The Series C financing round was led by the Redmile Group, with participation by new investor Rock Springs Capital and existing investors 5AM Ventures, Versant Ventures, HealthCap, Sectoral
The partnership is for up to 8 antibody therapeutics including ABL Bio’s biologics pipelines and collaboration programs between ABL Bio and I-Mab Biopharma (I-Mab). The agreement showcases the
DarwinHealth is a precision-focused cancer medicine company, utilizing systems-biology derived algorithms to identify appropriate therapies for cancer patients and to systematically discover and prioritize the next generation of
According to Cyxone, T20K during the preclinical program has been shown to be safe for people to ingest. The Swedish clinical biotech company, which has concluded the preclinical
Janssen Research & Development is undertaking the study. Vedanta Biosciences had granted the licensing rights of VE202 in 2015 to Janssen Biotech. The microbiome-derived product candidate is being
In addition, Zymeworks granted BeiGene a license to Zymeworks’ proprietary Azymetric and EFECT platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms.
The companies will advance drug discovery programs by gaining insights into the polypharmacological profiles of small molecules, while further evolving Cyclica’s integrated network of enabling technologies. Through a
Developed by AstraZeneca with MedImmune, its research and development arm, Fasenra was in-licensed from BioWa, a subsidiary of Japanese pharma company Kyowa Hakko Kirin. Considered to be a