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Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
According to research, the yeast-based process could not only make one of the most effective adjuvants more widely available, but also help lower the cost of vaccines overall.
Interim trial results show that the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb) provided rapid skin sign improvement in atopic dermatitis (AD).
The drug delivery system provides local release of erdafitinib and may offer an alternative treatment for eligible bladder cancer patients with limited options.
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
Key drivers of the global injectable drug market include technological advancement and an increase in chronic diseases such as cancer, due to treatments utilising this drug delivery method.
A Phase I/II trial has shown that a CRISPR-based gene editing therapy can be safely delivered to the retina and provide clinically meaningful outcomes.
Considering the limited available information on implementing mycobacterial testing for quality control of biologicals, researchers have highlighted a suitable potential alternative detection method.
AstraZeneca has released new clinical data demonstrating the first BTK inhibitor to show a favourable trend in overall survival versus standard-of-care chemoimmunotherapy in adults with untreated mantle cell lymphoma (MCL).
The National Institute For Health and Care Excellence (NICE)'s decision follows a reduction in the price of Pfizer’s small molecule treatment for sickle cell disease.
The at-line PAT method utilised machine-vision and was able to predict API content of tablets containing amlodipine and valsartan with low relative errors.
Incorporating artificial intelligence (AI) into the MHRA’s regulatory processes could help the agency focus on key priorities such as innovation.
New real-world evidence from a long-term follow up study adds to evidence of the high efficacy of Beyfortus in infant RSV.
