Drug Discovery & Development
FDA committee gives nod to Janssen COVID-19 vaccine
A single-shot COVID-19 vaccine from Johnson & Johnson's Janssen Biotech subsidiary has received a positive recommendation from a U.S. Food and Drug Administration (FDA) advisory committee. Should the FDA grant the product emergency use authorization, the vaccine candidate will become the third to be made available in the U.S. Read More
Clinical pipeline promises effective 2nd-generation COVID-19 vaccines
Despite the small number of COVID-19 vaccines that have been granted emergency use authorizations by the U.S. Food and Drug Administration to date, many biopharmaceutical companies are continuing to push new vaccine candidates toward regulatory approval. The slow rollout of approved vaccines has created the need for second-generation products with the potential to accelerate the world's return to something approaching normalcy. Read More
NIH adds long-acting antibody COVID-19 therapy to ACTIV-3 master protocol
The National Institutes of Health (NIH) has begun a new arm of its master protocol, the Accelerating COVID-19 Therapeutic Interventions and Vaccines 3 (ACTIV-3) study, which evaluates the safety and efficacy of an investigational long-acting antibody combination for the treatment of patients hospitalized with COVID-19. Read More
COVID-19 vaccines may be causing orofacial reactions
The two COVID-19 vaccines being given to patients in the U.S. and other countries have been linked to orofacial adverse drug reactions such as temporary facial paralysis, according to a brief report published on February 1 in the Journal of Oral Pathology & Medicine. Read More
Acute SARS-CoV-2 infection elicits distinct antibody, T-cell responses
An analysis of antibody and T-cell responses during the entire timeline of SARS-CoV-2 infection reveals the different ways the immune system responds to the virus in the early phases of COVID-19 disease. The results, published in Cell Reports on January 21, suggest that T-cell responses may be important for controlling infection while antibodies provide longer protection. Read More
SARS-CoV-2 mutation doesn't affect viral spread, but may limit therapies
As SARS-CoV-2 spreads around the globe, mutations of the virus are inevitable. An international team of researchers sought to define the effects of a specific receptor-binding motif mutation on viral fitness, clinical outcomes, and resistance to therapeutic antibodies. The findings of the study were published on January 28 in Cell. Read More
Designer DNA therapies shown to effectively target cancer stem cells
Using an engineered DNA therapeutic agent to silence transcription factor genes reduced myeloma stem cell abundance and increased the survival of mice bearing human myeloma, according to preclinical study data published in Cell Stem Cell on January 20. The results of the study have prompted the clinical investigation of a therapeutic candidate for the treatment of multiple myeloma. Read More
Beyond capital -- what it takes for biopharma startups to succeed
Investors are more interested in the biopharmaceutical sector than ever before. But success for biopharma startups means more than just securing investment funds -- it requires successful product commercialization. A panel of biopharmaceutical and finance executives discussed the factors that go into ensuring success on January 12 at the Biotech Showcase virtual event. Read More
Development 'cookbooks' could speed up gene therapy
Great strides have been made in the development of gene editing tools in the past decade, but translating the technology into real therapies to treat patients has taken longer than expected. How to accelerate this process was the subject of a panel discussion on January 13 at the Biotech Showcase virtual event. Read More
How is the pharma-AI partnership landscape changing?
Artificial intelligence (AI) is taking on a growing role in drug discovery and development, with some 250 firms in a market space that's worth over $9 billion. And developers of AI are becoming attractive acquisition targets for contract research organizations, according to Ulrik Kristensen, PhD, research analyst and founder of Emersion Insights. Read More
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