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Drug Shortages FDA V13K15

Agreement between Hikma and Civica to reduce US generic drug shortages

Home/Pharma News | Posted 23/08/2019

Hikma Pharmaceuticals Plc and Civica Rx announced a five-year agreement on 23 July 2019. Under the agreement, Hikma will manufacture and supply 14 essential sterile injectable medications for Civica. It will use Hikma's abbreviated new drug applications (ANDAs) and Civica's labelling and National Drug Code (NDC). The full list of medications included in the agreement, that are often in short supply in US hospitals, will be publicly announced in the near future. Initial shipments are expected by the end of 2019.

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WHO essential medicines list: new lung cancer medicines rejected

Home/Pharma News | Posted 16/08/2019

The World Health Organization’s (WHO) list of ‘essential medicines’, received a biennial update on 9 July 2019. It added 28 drugs but left out several new treatments for lung cancer.

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Prestige and Pharmapark make deal for trastuzumab biosimilar

Home/Pharma News | Posted 09/08/2019

Singapore-based Prestige BioPharma (Prestige) and Russia-based Pharmapark announced on 8 July 2019 that they had signed an exclusive partnership and supply agreement for Prestige’s candidate trastuzumab biosimilar (HD201) in Russia.

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Celltrion and Nan Fung Group form joint venture for copy biologicals in China

Home/Pharma News | Posted 02/08/2019

South Korean biosimilars firm Celltrion and Hong Kong-based Nan Fung Group announced on 18 July 2019 that the two companies had formed a joint venture, Vcell Healthcare, with the aim of developing and commercializing copy biologicals in China.

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STADA and Xbrane strengthen biosimilars collaboration

Home/Pharma News | Posted 19/07/2019

German generics giant Stada Arzneimittel (Stada) and Swedish biotech company Xbrane Bioscience (Xbrane) announced on 31 May 2019 that they have expanded their strategic biosimilar development partnership.

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Boehringer Ingelheim finally signs licensing deal for Humira biosimilar

Home/Pharma News | Posted 21/06/2019

Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.

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Sandoz and EirGenix make deal for trastuzumab biosimilar

Home/Pharma News | Posted 07/06/2019

Sandoz, the generics division of Novartis, announced on 30 April 2019 that it had signed an agreement with Taiwan’s EirGenix to market a proposed trastuzumab biosimilar.

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Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan

Home/Pharma News | Posted 17/05/2019

Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan.

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Alteogen gains patent on SC trastuzumab biosimilar

Home/Pharma News | Posted 10/05/2019

South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).

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First Chinese biologicals maker receives EMA GMP certification

Home/Pharma News | Posted 03/05/2019

China-based WuXi Biologics announced on 20 March 2019 that it had received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).