news
sa-mRNA vaccine facilitates durable COVID-19 immunisation
A novel sa-mRNA vaccine has demonstrated the ability to provide prolonged protection against COVID-19 at lower doses, Phase I/II data shows.
List view / Grid view
Antibodies
whitepaper
Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
article
European Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
news
CHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
news
GSK shingles vaccine achieves 100 percent efficacy in China trial
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.
news
Pfizer maternal RSV vaccine approved
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.
news
CDMO to manufacture SARS-CoV-2 intranasal vaccine
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.
news
Lilly completes biopharma acquisitions
Lilly expands its portfolio of treatments for cardiometabolic diseases with acquisition of Versanis Bio and Sigilon Therapeutics.
article
Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution
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.
news
MHRA authorises new COVID-19 vaccine
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.
whitepaper
ebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
news
New data suggests novel mAb could delay progression of early Alzheimer’s
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.
article
Re-engineering proteins to develop novel immunotherapies
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.
news
Innovative PAT-based filtration strategy reported for continuous biomanufacturing
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.
news
BioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
