Merck (known as MSD outside of the US and Canada) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for KEYTRUDA.
16 Oct 2023
05 Jun 2023
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ olverembatinib for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumour (GIST).
20 Dec 2022
Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) has secured approval in the European Union (EU) as a monotherapy to treat adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received an earlier trastuzumab-based regimen.
09 Dec 2021
Prestige BioPharma and Dr. Reddy’s Laboratories have signed a binding agreement to commercialise the former’s trastuzumab (HD201) biosimilar in select Latin America and Southeast Asian countries.
18 Mar 2021
The US Food and Drug Administration (FDA) grants orphan drug designation to Ambrx for ARX788, a homogeneous and highly stable antibody drug conjugate, for the treatment of HER2-positive gastric cancer.
05 Mar 2021
Clinical-stage biotechnology company Amgen has signed an agreement to acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of around $1.9bn.
19 Jan 2021
Chinese pharmaceutical company Innovent Biologics has signed an out-license agreement with Etana Biotechnologies to develop and commercialise cancer drug BYVASDA (Bevacizumab Biosimilar) in Indonesia.