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China s Clover generates US$230m in funding as its COVID-19 vaccine candidate edges towards late stage clinical trial

Subscribe China’s Clover generates US$230m in funding as its COVID-19 vaccine candidate edges towards late stage clinical trial By Jane Byrne Clover Biopharmaceuticals today announced that it has raised US$230m in Series C financing, bringing to over US$400m the funds it has generated in the past 12 months. The round was co-led by GL Ventures, the early stage affiliate of Hillhouse Capital, and Temasek, with participation from Oceanpine Capital, OrbiMed and existing investor Delos Capital.  Clover plans to initiate a global phase 2/3 efficacy study for its S-Trimer COVID-19 vaccine candidate in the first half of this year. The company said it has started production planning for potentially hundreds of millions of doses of the vaccine in 2021, and the proceeds from this financing will help to move this production forward.

Developing vaccines and therapeutics for virus variants: FDA releases new guidance

The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.

Celltrion secures EU approval for its adalimumab biosimilar

Celltrion secures EU approval for its adalimumab biosimilar Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. CT-P17 is the first approved adalimumab biosimilar in the EU with a high concentration, low-volume, and citrate-free formulation. Such formulations area said to reduce injection discomfort. The EC approval of Yuflyma follows the recommendation for marketing authorization issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December last year. In terms of the administration device, Dr HoUng Kim, head of the medical and marketing division at Celltrion Healthcare, said the South Korean company looked to ensure improved convenience for patients in terms of the administration device - it includes a pr

UK to launch new US$1 1bn DARPA-like research agency to support high risk, high reward science

Setback for AstraZeneca checkpoint inhibitor in US bladder cancer treatment

Setback for AstraZeneca checkpoint inhibitor in US bladder cancer treatment AstraZeneca is voluntarily withdrawing the use of its cancer drug, Imfinzi, to treat advanced bladder cancer in the US after it did not meet post-approval requirements. This decision was made in consultation with the Food and Drug Administration (FDA). Imfinzi (durvalumab) is a human monoclonal antibody that is designed to bind to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor s immune-evading tactics and releasing the inhibition of immune responses.  Revenues from Imfinzi grew 42% to $1.48bn in the first nine months of 2020, the company reported.

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