The week in industry: AstraZeneca announces three, global-medicine R&D initiatives in China

This week: Sandoz (Holzkirchen, Germany) receives US FDA approval for its febrile neutropenia-induced infection treatment, Biogen (MA, USA) seeks to expand its biosimilar portfolio and an international collaboration aims to develop DNA damage response inhibitors.

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Nov 07, 2019
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This week's industry news:  

AstraZeneca announces three initiatives to advance global medicine R&D in China
Sandoz receives US FDA approval for febrile neutropenia-induced infection treatment
Biogen and Samsung Bioepis partner to expand biosimilar portfolios
International collaboration to progress development of DNA damage response inhibitors 


AstraZeneca announces three initiatives to advance global medicine R&D in China

AstraZeneca (Cambridge, UK) has announced the initiation of three, large-scale initiatives aiming to progress global medicine R&D in China. The announcement was made at the 2nd annual China International Import Expo (5–10 November 2019; Shanghai, China) and includes plans for AstraZeneca to develop a new, Global R&D Center, an artificial intelligence-based Innovation Center and a novel Healthcare Industrial Fund, in partnership with China International Capital Corporation Limited (Beijing, China).

Pascal Soriot, CEO of AstraZeneca, commented: “China is rapidly emerging as a global scientific powerhouse, which is why we have taken this exciting decision to follow the science, by expanding our R&D presence and by working with the investment community. We will make the most of our global resources and network to strengthen the connections between China and the rest of the world in the field of healthcare innovation and, ultimately, bring the benefits of that work to patients everywhere.”

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Sandoz receives US FDA approval for febrile neutropenia-induced infection treatment

Sandoz (Holzkirchen, Germany) – a Novartis division dedicated to biosimilar production and marketing – has received US FDA approval for Ziextenzo™, its pegfilgrastim biosimilar for the treatment of febrile neutropenia-induced infection. Ziextenzo has been approved for use in Europe since 2018. The US-approval follows the demonstration that Ziextenzo exerted comparable pharmacokinetics and pharmacodynamics to both US- and EU-sourced reference pegfilgrastims.

Carol Lynch, President of Sandoz, stated: “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio® – the leading filgrastim by market share in the USA – including consistent product supply and reliable patient services.”

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Biogen and Samsung Bioepis partner to expand biosimilar portfolios

Biogen (MA, USA) and Samsung Bioepis (Incheon, Korea) have jointly announced their collaboration that will see the expansion of Biogen's next-generation biosimilar portfolio. Under the arrangement, Biogen will gain exclusive rights to commercialize two of Samsung Bioepis’ novel ophthalmology biosimilars in the USA, Europe, Australia, Canada and Japan. Further, Biogen will gain rights to exclusively commercialize three anti-TNF-α biologics in China – etanercept, infliximab and adalimumab.

Michel Vounatsos, Biogen’s CEO commented: “We are excited about the potential to bring biosimilars to a new therapeutic area as well as new regions around the world with the goal of sustainably advancing broad access to care for patients in need. This transaction would expand the potential for our leading biosimilars business worldwide, while complementing Biogen’s presence in ophthalmology.”

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International collaboration to progress development of DNA damage response inhibitors

Artios Pharma (Cambridge, UK), ShangPharma Innovation (CA, USA) and the University of Texas MD Anderson Cancer Center (TX, USA) have jointly announced an in-licensing agreement concerning the development and marketing of a small-molecule, DNA damage response inhibitor, which offers a potential new therapeutic avenue for oncology indications. The arrangement will see Artios gain exclusive global R&D, manufacturing and commercialization rights for the inhibitors. A lead drug candidate is predicted to be ready for application for Investigational New Drug designation in 2020.

Niall Martin, CEO of Artios, stated: “This program has the potential to be a highly effective DNA damage response-targeted treatment in cancer. We look forward to advancing the work done by MD Anderson and ShangPharma for the benefit of cancer patients."

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