HYDERABAD, India – A number of drug companies in India may have to repeat expensive clinical trials after Bangalore-based contract research organization (CRO) Semler Research Center Pvt. Ltd. received warnings from both the World Health Organization (WHO) and the FDA in April over data manipulation.
HONG KONG & NEW DELHI – Middle East respiratory syndrome (MERS) is in the spotlight across Asia, as researchers search for drugs to fight a virus many fear could be as devastating as SARS was in 2003.
DUBLIN – Nasdaq continues to put out the welcome mat for European drug development companies, with Ascendis Pharma A/S becoming the latest in a lengthening roster of firms to take up residence on the New York-based exchange.
As expected, the FDA cleared for marketing Wednesday recombinant human C1 esterase inhibitor Ruconest (conestat alpha) for use in acute attacks of hereditary angioedema (HAE), news that should bring an immediate lift to developer Pharming Group NV – in the form of a $20 million milestone payment from partner Salix Pharmaceuticals Inc. due upon the first U.S. sale – but offers little clarity as to how the drug will stack up against well-entrenched competitors in the crowded HAE space.
Visudyne developer QLT Inc. brings more than a Canadian address and its synthetic retinoid program to men's health care firm Auxilium Pharmaceuticals Inc. It brings the potential for a more favorable tax rate.
Reducing intraocular pressure (IOP) in a phase IIb trial and providing new hope for glaucoma patients, Aerie Pharmaceuticals Inc.'s quadruple-acting combination drug Roclatan nailed its primary endpoint by showing statistically significant superiority over each of its components.
LONDON – In January 2013, Thomson Reuters Cortellis for Competitive Intelligence highlighted five drugs to watch that were predicted to achieve significant regulatory milestones and produce sales of more than $1 billion within five years.
In findings that, in addition to their practical relevance, upend current ideas of the relative importance of genetics and environment for the determination of cell fate, researchers have generated pluripotent stem cells from differentiated cells of young mice without using any sort of genetic manipulation to do so. The only thing that was necessary was to expose the cells to stress, such as low pH or mechanical force.
