Thursday, August 27, 2015
The Pulse on Global Trials by Matthew Howes
If it has not become apparent to you over the last few years that the landscape is changing regarding the importance of a perspective site’s offer to sponsors and CROs, then one might infer you are missing the opportunity to better position your site for recognition and success.
Janus Biotherapeutics, a Massachusetts-based autoimmunity therapeutics company, is collaborating with Roche on the development of a small molecule toll-like receptor (TLR) inhibitor with the potential to address several autoimmune diseases. TLRs are class of proteins in the innate immune system. Evidence links aberrant TLR activation and signaling with the development of autoimmune disorders. Janus will work exclusively with Roche on TLR R&D.
Roche has signed a definitive agreement to acquire Kapa Biosystems, a privately held company based in Wilmington, Mass. Kapa Biosystems is a provider of genomic tools in the life sciences sector that employs proprietary technologies to optimize enzymes for next-generation sequencing (NGS), as well as polymerase chain reaction (PCR) and real-time PCR applications.
Roche Pharma Research & Early Development (pRED) has developed a smartphone-based monitoring system for those with Parkinson’s disease (PD) that complements the traditional physician-led assessments with automated tests that continuously measure their symptom fluctuations. It could be the first time that such an app has been used to measure disease and symptom severity in a medicine development program in PD.
Roche has signed a definitive agreement to acquire GeneWEAVE BioSciences, a Los Gatos, Calif.-based, privately held company focused on clinical microbiology diagnostics solutions. Roche will pay GeneWEAVE shareholders $190 million upfront and up to $235 million in contingent product related milestones. The transaction is subject to customary closing conditions and, once closed, GeneWEAVE will be integrated into Roche Molecular Diagnostics.
Tekmira Pharmaceuticals, headquartered in Vancouver, Canada, plans to change its corporate name to Arbutus Biopharma, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), to be effective on or before Aug. 3. The name change affirms the successful integration of OnCore BioPharma and Tekmira Pharmaceuticals into a combined company with the singular goal of delivering a cure for chronic HBV. The combined entity currently fields a large portfolio of HBV product candidates in the industry.
Evotec was updated by its partner Roche on the initial results of the phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer’s disease (AD). In this study, Sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer’s Disease Assessment Scale—Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment.
Exelixis has been informed by partner Genentech, a member of the Roche Group, that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech’s NDA for cobimetinib by the standard extension period of three months, from Aug. 11 to Nov. 11.