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On Monday, the high-profile partnership between Japan’s Daiichi-Sankyo and British-Swedish multinational AstraZeneca announced that the United States Food and Drug Administration has accepted their supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), their HER2-directed candidate for unresectable or metastatic breast cancer.

Shares of Regulus Therapeutics plunged nearly 10% Monday after the company disclosed that its partner Sanofi has terminated a development agreement for a small RNA molecule inhibitor being developed for Alport syndrome. And on Monday, pharma giant Merck announced it has halted the Phase III LYNK-003 trial evaluating PARP inhibitor Lynparza for patients with unresectable or metastatic colorectal cancer who have not progressed following first-line induction.

One of the tenets of “personalized medicine” is that medications will be tailored to individuals based on their personalized genetics. Last year, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.

AstraZeneca is strengthening its oncology pipeline with the acquisition of TeneoTwo, which has an ongoing Phase I trial in relapsed and refractory B-cell non-Hodgkin lymphoma, in a deal valued at up to $1.27 billion. 

Wuxi Biologics, a Chinese company that makes ingredients for AstraZeneca’s COVID-19 vaccine, may be a step closer to being taken off a U.S. trade list that it landed on five months ago, wiping HK$77 billion ($9.9 billion) off its market value at the time.

The COVAX facility, backed by the World Health Organization and the Global Alliance for Vaccines and Immunization, has delivered 1.55 billion COVID-19 vaccine doses to 146 countries. In December, COVAX set a target of achieving 70% COVID-19 immunization coverage by mid-2022.

Under the expanded deal, AstraZeneca’s will have access to Oxford Biomedica’s Oxbox manufacturing facility to produce its shot on an as-needed basis beyond 2022.

AstraZeneca had a very busy week of international news, with progress being shown in China, positive recommendations for two drugs in Europe, and a positive clinical trial update.

AstraZeneca said on Thursday a combination of its cancer drug, Imfinzi, and chemotherapy showed promise in a late-stage trial in patients with an aggressive form of lung cancer, when given before surgery.

The company stated that two of its existing therapies were recommended for treating patients with some forms of high-risk breast cancers in the European Union, in a boost to the company’s oncology portfolio.