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LATEST

Poland and Slovenia Join EU-US Mutual Recognition Inspections Agreement
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The US Food and Drug Administration (FDA) has confirmed the capability of two additional European Union (EU) member states, Poland and Slovenia, to carry out good manufacturing practice (GMP) inspections…

Allogene Therapeutics to Build Cell-Therapy Mfg Facility for Cancer Therapies
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Allogene Therapeutics, a clinical-stage biotechnology company developing allogeneic chimeric antigen receptor T cell (CAR T) therapies for cancer, and headquartered in South San Francisco, California, has entered into a lease…

Novartis’ AveXis To Expand Gene-Therapy Manufacturing in North Carolina
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AveXis, a Novartis gene-therapy company headquartered in Bannockburn, Illinois, plans to invest an additional $60 million to expand its manufacturing center in Durham County, North Carolina to manufacture medicines for…

SK Biopharma and Arvelle Therapeutics in $530-Million Agreement
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SK Biopharmaceuticals, a pharmaceutical company based in Gyeonggi, South Korea, and Arvelle Therapeutics, a biopharmaceutical company based in Basel, Switzerland, have entered into an exclusive $530-million licensing agreement for Arvelle…

Glenmark To Spin Off Its Innovation Business Into New US Company
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Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, plans to spin off its innovation business into a new company as a wholly owned subsidiary of Glenmark based in the US. The…

Tris Pharma Extends Recall of Infant Ibuprofen Due to High Potency
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Tris Pharma, a Monmouth Junction, New Jersey-based specialty pharmaceutical company, is expanding its voluntary recall of infant ibuprofen by adding three additional lots to its US recall. The recall applies…

Samsung Bioepis, AffaMed Form Biosimilars Licensing Pact for China
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Samsung Bioepis, a Incheon, Korea-based biosimilars company, has formed a licensing agreement for biosimilars in China with AffaMed Therapeutics, a newly formed biopharmaceutical company founded and funded by C-Bridge Capital,…

Sanofi Names Chief Digital Officer
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As part of its strategy to integrate digital technologies and medical science, Sanofi has named Ameet Nathwani, MD, as Chief Digital Officer in addition to his current role of Executive…

FDA OKs Sanofi’s Rare-Disease Drug Cablivi
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The US Food and Drug Administration (FDA) has approved Sanofi’s Cablivi (caplacizumab-yhdp) for treating thrombotic thrombocytopenic purpura (aTTP), a rare disease that causes blood clotting. The drug was approved in…

Dr. Reddy’s Cited by FDA for Indian Formulation Mfg Plant
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The US Food and Drug Administration (FDA) has cited a formulations manufacturing plant in Bachupally, Hyderabad, India of Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, with the issuance of…