Sandoz and Teva achieve first-of-a-kind manufacturing certification
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
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In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
Increased production of biologic drugs in the global cell line development market is anticipated to bring “significant growth” for mammalian cell line development between 2023-2033, a report shows.
Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
Researchers from Washington State University have developed a centrifugal bioreactor, which they claim can manufacture T cells 30 percent faster than current technologies.
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
Vaccitech’s Chief Business Officer, Graham Griffiths, discusses key learnings in vaccine and drug development, the challenges of preparing for the unknown, and how strategic collaboration is imperative to achieve faster and more equitable outcomes - if and when another pandemic strikes.
Initial clinical results for a gene therapy being evaluated in limb-girdle muscular dystrophy has shown evidence of transgene expression in the three-month muscle biopsy.
The Biosimilar Medicines Group has reflected on a new report by IQVIA that outlines factors for achieving sustainable levels of biosimilar competition in Europe.
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.