List view / Grid view
Following WuXi Biologics’ proposed spin-off of its subsidiary, WuXi XDC has launched new manufacturing facilities that enable doubled capacity antibody intermediates and bioconjugate drug substances.
A novel sa-mRNA vaccine has demonstrated the ability to provide prolonged protection against COVID-19 at lower doses, Phase I/II data shows.
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
In the first-ever efficacy trial of GSK’s Shingrix in China, no cases of shingles (herpes zoster) were reported after administration of the vaccine, new data shows.
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
Lilly expands its portfolio of treatments for cardiometabolic diseases with acquisition of Versanis Bio and Sigilon Therapeutics.
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
Full results from the “first Phase III study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study” have been published in JAMA.
Jessicca Rege of Alkermes provides insights into how protein engineering approaches have led to the development of novel therapies that harness the immune system’s capabilities to fight cancer.
The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
