news
Ampion™ reduces severe knee osteoarthritis pain in 12 weeks
Ampion significantly reduced pain and improved function in severe osteoarthritis of the knee (OAK) in 12 weeks, shows Phase III study.
List view / Grid view
US Food and Drug Administration (FDA)
news
Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
news
Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
article
3D printing – current pharmaceutical applications and future directions
3D printing has the potential to revolutionise the pharmaceutical manufacturing industry; however, few 3D-printed products have been approved since the first in 2015. In this article, EPR’s Hannah Balfour explores the technologies currently being evaluated for use in the 3D printing of pharmaceuticals, and the work of key market players…
news
Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
article
Embedding inclusion in pharmaceutical design
In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.
news
Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic
Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.
news
FDA reaches over 100 Competitive Generic Therapy approvals
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
news
EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
news
FDA approves Invega Hayfera™ for the treatment of schizophrenia
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
news
Jardiance® displays 21 percent risk reduction in heart failure patients
Jardiance displayed a 21 percent risk reduction in adults with heart failure with preserved ejection fraction in Phase III study.
article
‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery
Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new…
news
Minjuvi® receives EC approval to treat large B-cell lymphoma
European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.
news
Vaxneuvance™ meets immunogenicity and safety endpoints in Phase III trial
Merck announces positive results from a Phase III study evaluating Vaxneuvance™ against a pneumococcal conjugate vaccine in infants.
news
FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
