Wednesday, January 28, 2015
A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.
Syncona, a London-based subsidiary of the Wellcome Trust, and UCL Business, the wholly-owned technology transfer company of University College London (UCL), have announced the creation of Autolus, a London-based biopharmaceutical company focused on the development and commercialization of next-generation engineered T-cell therapies for hematological and solid tumors. Autolus is founded upon the work of Dr. Martin Pule, an academic clinical hematologist and thought-leader in T-cell engineering. Syncona has committed $33.5 million to Autolus in a Series A financing. Dr. Christian Itin, former CEO of Micromet, has joined the company as chairman.
Pharmaceutical Product Development (PPD), a global CRO based in Wilmington, N.C., has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility. The new lab provides GMP bioassay testing with dedicated areas to support cell culture activities with multiple assay endpoint expertise.
The NHS Cancer Drugs Fund (CDF) has published a review of drugs included in the fund and increased the budget for cancer drugs. The budget for the CDF will grow from $235 million in 2013-2014, to $329 million in 2014-2015, and an estimated $400 million from April 2015. This represents a total increase of 70% since August 2014.
In 2014, the EMA recommended the highest number of orphan designated medicines for marketing authorization. Out of the 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, providing therapies for patients who often have only few or no treatment options.
The industry is closely watching the European Medicines Agency’s (EMA) experiment in adaptive licensing, which challenges the way new medicines are evaluated and approved—since a successful outcome could play an important role in moving the approach forward in the U.S. and other regions.
France Biotech, an association of entrepreneurs in the life sciences industry, has published the twelfth edition of its annual survey, Panorama of the Life Sciences Industry, which outlines the industry’s major trends for 2013 and 2014 in France and worldwide. This year, 214 French companies took part in the study. France Biotech included multiple recommendations to foster excellence in the life sciences industry.
CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has won a European Venture Contest award. The award program, which is part of the European Venture Summit, acknowledged CluePoints for its Central Statistical Monitoring (CSM) solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data. The win represents the second industry award that CluePoints has secured this month after the company’s risk-based monitoring solution also was recognized by the Scrip Awards.