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October 01, 2020
The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.
September 28, 2020
With little more than a month to go until the national election, President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.
Steven J. Lynn previously held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs.
September 24, 2020
UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.
FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.
September 22, 2020
Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.
The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The rebranding stems from the company’s expanded services which include 3PL services, supply chain transparency solutions, and retail pharma product procurement for over-the-counter medications.
September 21, 2020
Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.