A new Supreme Court ruling has re-examined the criteria for patenting diagnostic tests, which may have a significant impact on personalized medicine. The Court declared two tests patented by Nestlé’s Prometheus Laboratories invalid because the methods contained within them are already recognized and practiced by scientists. The Court dismissed Prometheus’s claim that its steps were […]

The FDA approved 34 new molecular entities in its fiscal year ending September 30, 2011; the highest number since 2007. Eleven biologics license applications were approved. Biologic approvals included a high number of orphan indicators and first-time approvals for companies. Seattle Genetics’ Adcetris for treating Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma was approved. […]

On February 9, the FDA released its guidelines on biosimilars, which propose an “abbreviated pathway” for approval that would vary by product. The biosimilar must be shown to be “highly similar” to the original. The requirements for clinical and animal studies would depend on an evaluation of analytical data, as well as scientific and manufacturing […]

The number of hectares of biotech crops increased 8% in 2011 to 160 million. Twenty-nine countries grew biotech crops last year, led by the US (43% of total hectares), Brazil (19%) and Argentina (15%). Twelve countries planted stacked-trait crops, which accounted for 42.2 million hectares. Brazil was the country whose hectarage of biotech crops grew […]

The percentage of NIH research grant applications that were funded fell 3% to a record low of 18% in fiscal 2011. The decline is mainly due to the funding of continuing multiyear R01 grants. Funding such grants cost the NIH an additional $189 million and accounted for 78% of available grant money. Another factor was […]