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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Industry should improve the standards for detecting drug impurities.
With many on-site visits on hold, FDA seeks alternatives
Using secondary reference standards poses scientific challenges.
With the proper technology, remote auditing can be effective.
February 26, 2021
EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.
NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.
February 22, 2021
The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.
February 19, 2021
FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.
February 17, 2021
The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.
FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
February 15, 2021
Labeling, printing, and on-dose tagging technologies provide a multi-layered approach to anticounterfeiting for pharmaceuticals.
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
February 12, 2021
Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.
The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.
February 11, 2021
EMA has clarified its position on the European approval process of the Sputnik V vaccine.
February 10, 2021
Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.
FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.
The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.
Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
February 04, 2021
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.
PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.