Browsing Tag

Manufacturing

678 posts

Global Pharma Briefs: News from BI, CureVac, Atriva & Alladapt
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A roundup of news from Germany (Boehringer Ingelheim and CureVac) and the US (Artiva Biotherapeutics and Alladapt Immunotherapeutics). Germany BI, CureVac To End mRNA Cancer Vaccine PactCureVac, a Tubingen, Germany-based…

FDA Cites Possible Cybersecurity Vulnerabilities in Drug Mfg Equipment
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The US Food and Drug Administration (FDA) is informing patients, healthcare providers, and manufacturers about cybersecurity vulnerabilities with a real-time operating system (RTOS) designed by QNX and owned by BlackBerry…

Pfizer Expands Recall of Chantix Due to Nitrosamine Impurities
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Pfizer is voluntarily recalling an additional four lots of its smoking-cessation product, Chantix (varenicline) (0.5 mg/1 mg tablets) to the patient (consumer/user) due to the presence of a nitrosamine impurity,…

UK Regulators Recall Batches of “Sartan” Drug for Azido Impurities
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The UK Medicines and Healthcare products Agency (MHRA) is recalling 25 batches of irbesartan-containing products as a precautionary measure due to contamination with an azido impurity, which the agency says…

EMA Endorses Recommendations for Track-and-Trace Systems
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The European Medicines Agency (EMA) has endorsed the International Coalition of Medicines Regulatory Authorities’ (ICMRA) recommendations to facilitate the use of track-and-trace systems at the global level. The ICMRA, a…

Pharma COVID Roundup: News from AstraZeneca, Moderna, Thermo Fisher
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The latest on COVID-19 vaccines/drugs, manufacturing, and testing from AstraZeneca, Moderna, Sk Bioscience, Inovio, Sinovac, the FDA, the World Health Organization, and Thermo Fisher Scientific. Manufacturing and supply of COVID-19…

Pfizer, BioNTech Plan Mfg Capacity of 4 Bn Doses of COVID Vaccine
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Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, expect annual manufacturing capacity for BNT162b2, their COVID-19 vaccine, to reach three billion doses by the end of 2021 and up to…

Moderna, Canadian Gov’t Plan Pact for New mRNA Mfg Facility
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Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced a memorandum of understanding with the Canadian government to build a mRNA vaccine-manufacturing facility in Canada. The…

Global Pharma Briefs; News from Astellas, Gilead, and Alnylam
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A roundup of news from Japan (Astellas, Minovia) and the US (Gilead Sciences, Alnylam, Lumen Bioscience, and Spectrum Pharmaceuticals). Japan Astellas, Minovia Therapeutics in Cell-Therapy PactAstellas and Minovia Therapeutics, a…

Gilead, Appia Bio in $875-M Pact for Allogeneic Cell Therapies
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Kite, part of Gilead Sciences, and Appia Bio, a Los Angeles, California-based bio/pharmaceutical company developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs), have entered into a collaboration and…