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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.
Interim trial results show that the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb) provided rapid skin sign improvement in atopic dermatitis (AD).
Christopher Weidenmaier, PhD, Chief Scientific Officer, and Johannes B. Woehrstein, PhD, Chief Technology Officer at mbiomics share with EPR about the challenges and considerations of manufacturing microbiome-based therapeutics.
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
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.
New real-world evidence from a long-term follow up study adds to evidence of the high efficacy of Beyfortus in infant RSV.
Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma, discusses the current trends in biologics and how technologies such as automation are advancing the field.
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing.
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
The new members of the Cell and Gene Therapy Catapult’s board hold expertise across therapy development, digitalisation and leadership.
This in-depth focus features articles on bioreactor size, as well as bioprocess development and manufacturing of bioconjugated products.
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
