In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.
Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.
A novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer was recently launched at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM).
Florian Krammer explains how a novel technology using insect cells can accelerate the manufacture of pandemic influenza vaccines.
The overarching aim of personalised medicines is to individualise and stratify medicines to maximise benefit, minimise harm and optimise allocation of resources (e.g., for expensive drugs).
In 2009, the BioMedical Materials (BMM) programme, the Center for Translational Molecular Medicine (CTMM) and Top Institute Pharma (TI Pharma) issued a joint call to stimulate research consortia to look for new healthcare solutions at the interface of three research areas: drug delivery and targeting, imaging and new biomaterials.
Molecular diagnostics is one of the fastest growing segments of the in vitro diagnostics market and, within this, personalised medicine is at the forefront. Personalised medicine is particularly interesting to the diagnostics industry as it represents a brand new sector for our products.
While sequencing a single human genome is a scientific curiosity, the scientific community needs to sequence thousands of complete genomes to obtain real transformational insights into the genetic basis of human disease, including cancer. Previously, human genome sequencing was simply too complex and expensive for scientists to carry out large-scale human disease studies; however, major capital investment is no longer required with the commercial scale sequencing service that Complete Genomics provides
T cell therapy is an investigational approach that is being assessed for the patient?specific treatment of cancer.
Single nucleotide polymorphisms (SNPs) are responsible for more than 80% of the variations between individuals, and are present throughout most genes and other important sequences in the human body, which makes them ideal for tracking down correlations between genotype and phenotype.
In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.
Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.
Pfizer Invests In Nodality; SOCMA Approves New Members; And More.
Why do some people contact diseases while others stay healthy? This is a central question in medicine. Similarly, why some individuals recover quickly using drug treatments while others do not is a fundamental question in pharmacology.
Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
FDA issued a final rule to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents.
Seventeen pharmaceutical markets are now ranked as "pharmerging," according to market-research firm IMS Health.
FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.
Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.
A report from Thomson Reuters claims the number of patent challenges in the US almost doubled between 2008 and 2009.
Abbott Agrees to Acquire Facet Biotech; FDA Issues Black-Box Warning For Plavix; and More.
AstraZeneca signed a license and supply agreement with the drug company and manufacturer Torrent Pharmaceuticals.
Three companies joined the University of Pittsburgh Medical Center's 21st Century Biodefense initiative to establish a flexible vaccine development and production facility.
