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Applied Clinical Trials
A compilation of recently released news briefs that pertain to the clinical trials industry.
The alarming spread of the dangerous virus that emerged several weeks ago in Wuhan, China, is prompting small biotech researchers and leading pharma companies to launch a range of initiatives for developing new treatments, preventives, and diagnostics. The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility. As of Feb. 5, the virus (2019-nCoV) had infected more than 24,000 people and caused nearly 500 deaths, but these numbers increase daily.
A first step for FDA was to grant Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) to distribute a new coronavirus diagnostic, permitting qualified laboratories around the country to use the test, as opposed to just the federal agency. Meanwhile, a number of companies have announced plans to test promising and related compounds for effectiveness against the new virus. Regeneron, for instance, is looking to parlay its research on an antibody against Ebola into a treatment for the coronavirus. Similarly, Gilead says it plans to test its experimental antiviral drug remdesivir, which has been in Ebola clinical trials and was administered to a U.S. patient infected with the new virus, with positive, but inconclusive, results. Gilead has provided the drug to Chinese officials who have set up a process for conducting randomized clinical trials on multiple infected patients and with multiple compounds. Several trials sponsored by academic research institutions are testing drugs approved to treat AIDS and hepatitis for effectiveness against the new coronavirus.
The Discovery Labs and Deerfield Management Company have formed The Center for Breakthrough Medicines, a contract development and manufacturing organization (CDMO) and specialty investment company, to alleviate the critical lack of capacity that is preventing patients from accessing needed cell and gene therapies. The CDMO is occupying over 40% of The Discovery Labs’ 1.6 million square foot biotech, healthcare, and life sciences campus in King of Prussia, PA.
The CDMO provides preclinical through commercial manufacturing of cell and gene therapies and component raw materials. The $1.1 billion facility will offer process development, plasmid DNA, viral vectors, cell banking, cell processing, and support-testing capabilities, all under one roof. The company expects to hire over 2,000 team members within the next 30 months.
The CRO Synteract has acquired Clindata’s human health biometrics division to meet market demand for more adaptable biometrics services solutions. The acquisition extends Synteract’s existing global footprint into Asia-Pacific and Africa, and offers another core biometrics services hub, complementary to those it operates in Europe and the U.S. Clindata, with offices in Bloemfontein, South Africa, and Colombo, Sri Lanka offers biostatistics, programming, and data management services across all phases of drug development.
WCG (WIRB-Copernicus Group) has acquired Washington, DC-based Statistics Collaborative, Inc., which provides specialized biostatistical consulting services to developers of new drugs and biologics. While the company’s primary focus is on late-stage clinical trials, it also contributes to epidemiological studies, preclinical studies, and non-clinical research. Statistics Collaborative focuses in multiple therapeutic areas, including cardiovascular diseases, oncology, infectious diseases, orphan diseases, and vaccines.
Bio-Techne, Fresenius Kabi, and Wilson Wolf have established a new joint venture company to provide dedicated support to researchers and biopharma companies for cell and gene therapy. It will focus on providing scalable manufacturing technologies and processes needed to develop and commercialize new cell and gene therapy products.
Eli Lilly and Company entered into a definitive agreement last month to acquire Dermira for $18.75 per share, or approximately $1.1 billion, in an all-cash transaction. Dermira is a biopharma company dedicated to developing new therapies for chronic skin conditions. The acquisition will expand Lilly’s immunology pipeline.