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Keys to Success in Vaccine Development for Special Populations

PPD

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

The Pharma Data

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. About Merck.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. These submissions contain comprehensive data on clinical efficacy, pharmacokinetics, pharmacodynamics, and risk-benefit assessments.

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FDA Action Alert: MacroGenics and Amgen

The Pharma Data

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Zai Lab is leading clinical development in its territory. “We Although much of the U.S.

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Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process. When should this occur? at the end-of-phase 2 meeting).

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Tiziana Life Sciences plc announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in Brazil

The Pharma Data

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected. A further announcement will be made in due course.

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Can Your CRO Add Value During a Recession?

PPD

Likewise, and particularly since partnering with Moderna on the development of its COVID-19 vaccine, we know that novel therapeutic platforms will continue to hold strong potential for priority therapeutic areas. Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy?