Most people in the drug discovery community have become familiar with what has been called “the obligatory graph”—a comparison showing a continual increase in R&D investment by the pharmaceutical industry coupled with a disappointingly low production of approved new molecular entities (NMEs). In fact, in 2005, only 18 NMEs were approved by the FDA, the second lowest count in the past decade. Concomitant with this shortfall is a rising tide of patent expirations of existing blockbuster drugs. Likewise, there has been a steadily increasing proportion of prescriptions dispensed for generics relative to drugs with market exclusivity.
Advances in genomics, proteomics, and metabolomics over the last decade have provided an unprecedented, exquisitely detailed view into the molecular nature of disease and treatment. Biomarkers are among the most practical tools arising from the “omics” revolution.
The most affordable or effective therapeutics are useless if clinicians can’t get the right drugs to the right people. For this to occur, effective disease diagnosis is critical. But therein lay the problem, because the developing world is faced with a variety of challenges that are rare or unknown elsewhere. Recently, I had the opportunity to speak with a number of NGOs and diagnostics companies to examine the reasons behind these challenges and possible solutions.
Most people have a soft spot for orphans. These unfortunate souls, often depicted with unusually large and needy eyes, tug at the heartstrings.
Such has not always been the case in the pharmaceutical industry, where an orphan is a treatment for a rare disease that occurs in fewer than 200,000 people in the United States, as defined by the FDA’s Orphan Drug Act, passed in 1983.
VisualSonics announced an exclusive agreement with the Bracco Group for the joint development and manufacture of a new line of MicroMarker contrast agents for use in preclinical molecular imaging on the VisualSonics Vevo 770 micro-ultrasound platform.
DiscoveRx Corp., which thus far has been known primarily for being the provider of the off-the-shelf HitHunter assays, has made things personal—or at least personalized—by launching custom labeling and profiling services.
Applied Biosystems Inc. announced it had entered a definitive agreement to acquire for $120 million Agencourt Personal Genomics (APG), a privately-held research and development company focused on the development of next-generation genetic analysis technologies.
The Spinal Muscular Atrophy Foundation announced last month it agreed to fund research efforts targeting the disease by PTC Therapeutics Inc., a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes.
Cytopia Ltd. recently announced the signing of a global license and research and development collaboration with Novartis to develop orally active, small-molecule therapeutics targeting the JAK3 kinase for the prevention of transplant rejection and the treatment of autoimmune diseases such as rheumatoid arthritis.
To build an electronic infrastructure for translational medicine and technology, the Windber Research Institute (WRI) announced recently it entered into a strategic arrangement with the Shanghai Center for Bioinformation Technology (SCBIT).
Waters Corp. announced recently that it had entered into a co-marketing agreement with Umetrics AB of Umea, Sweden, under which Waters will begin offering scientists a direct link to Umetrics’ SIMCA-P multivariate statistical analysis software as an option compatible with Waters’ MarkerLynx 4.1 Software.
To boost opportunities in the industrial fermentation market, including pharmaceuticals, the Netherlands’ Kluyver Centre—a joint industry and academic consortium that applies genomics to improve industrial fermentation—has turned to Swiss bioinformatics company Genedata.
The European Commission (EC), European Medicines Agency (EMEA) and the US FDA announced they have agreed to a procedure for joint FDA-EMEA meetings with sponsors about voluntary genomic data submissions (VGDS).