Drug Discovery & Development
Canadian experts discuss somatic gene therapy approval and use
Gene therapies offer great benefits to patients but could strain healthcare budgets and exacerbate existing treatment inequities in Canada, according to an expert panel that was commissioned to write a report by the Council of Canadian Academies. Read More
FDA issues guidance on submitting EUA requests for COVID-19 vaccines
The U.S. Food and Drug Administration (FDA) on October 6 issued a new guidance with recommendations for developers of COVID-19 vaccines regarding the scientific data and information that would be required to support emergency use authorization (EUA) for the products. Read More
Is 'bespoke' therapy the future of genomic medicine?
Gene therapies hold extremely exciting promise for meeting the unmet needs of many individuals with genetic diseases, as discussed in a session of the second annual American Society of Gene & Cell Therapy Policy Summit on September 24. Read More
Customized gene therapies successfully target rare eye diseases
Can gene therapies prove effective for the treatment of rare genetic diseases? One company may have found a solution that incorporates a high degree of customization, manufacturing expertise, and years' worth of knowledge. Read More
Sharing is caring: Why COVID-19 vaccine manufacturers must collaborate
Sharing knowledge between competitors will be key for establishing the manufacturing capacity needed to produce billions of COVID-19 vaccines in coming months. Such collaboration could change the way that innovation and competition are viewed in the biopharmaceutical industry, according to a policy forum published in Science on August 13. Read More
Biosimulation can mitigate risk of COVID-19 drug development
Drug development can be an expensive and tedious process. Add in the urgency of the COVID-19 pandemic, and you have a recipe for frustration. Biosimulation -- using computers to simulate drug response in humans -- can help accelerate the process, which Certara hopes to achieve with a newly launched platform targeted at COVID-19 vaccine development. Read More
Transparency helps maintain scientific integrity of clinical trials
A new study offers reassuring evidence about the integrity of registered clinical trials, with researchers finding no signs of widespread manipulation of results regarding statistical significance thresholds. The study results were published in the Proceedings of the National Academy of Sciences on June 2. Read More
U.S. launches project to promote pharma manufacturing
The U.S. Department of Health and Human Services on May 19 announced a new project to promote U.S.-based pharmaceutical manufacturing to secure the supply of essential medicines during crises like the COVID-19 pandemic. The project includes a $354 million contract with Phlow of Richmond, VA. Read More
NIH leadership discusses COVID-19 vaccine collaborations
Public-private partnerships could help meet the unprecedented need to manufacture and distribute safe and effective COVID-19 vaccines around the globe, according to leaders from the U.S. National Institutes of Health (NIH) and the Fred Hutchinson Cancer Research Center. They discussed how in Science on May 11. Read More
COVID-19: A double-edged sword for the pharma industry
The COVID-19 pandemic is causing major disruptions to pharmaceutical R&D activities, despite the pressing need for treatments and diagnostics for the novel coronavirus. In a new article, Ivan Gandayuwana of Strategic Directions International examines the multiple impacts COVID-19 is having on pharma. Read More
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