The Cell Therapy Catapult, which focuses on the development of the UK cell therapy industry, said it will work with London-based GlaxoSmithKline plc to explore potential collaborations in a range of areas relevant to the development of cell therapies, from research projects to technical and regulatory strategy. GSK is developing a bone marrow-derived stem cell gene therapy through late phase development and has a small number of collaborations in that field.
Last month's FDA workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) – the first of its kind, one of 20 mandated by the Prescription Drug User Fee Act – hardly transformed the treatment landscape in the aftermath of the agency's refusal to approve the Toll-like receptor 3 modulator Ampligen (rintatolimod), the CFS therapy from Hemispherx Bioscience Inc. But patients and their advocacy groups were given hope, and the FDA is taking comments from the public until August
By Randy Osborne | BioWorld Today | Wednesday, May 22, 2013
AB Science SA, of Paris, began a Phase III trial of masitinib, a drug it already has studied broadly in cancer indications, in Alzheimer's disease. The company documented significant efficacy for masitinib in Phase II as an add-on to standard care over 24 weeks, with improvement in cognitive function and functional capacity in the treatment group, plus sustained and statistically significant response on the Alzheimer's Disease Assessment Cooperative Study Activities on Daily Living (ADAS-ADL
By Catherine Shaffer | BioWorld Today | Wednesday, May 22, 2013
LONDON – As pharma's quest for pipeline-boosting innovation pushes further into academia, GlaxoSmithKline plc (GSK) has launched Discovery Fast Track to accelerate the translation of target biology into drug candidates. The company is organizing a competition in which academics submit a one-page application outlining a novel drug development concept. Ten winners will get access to GSK facilities to scale up biological reagents and develop assays to underpin high-throughput screening against the
By Nuala Moran | BioWorld Today | Wednesday, May 22, 2013
Addex Therapeutics SA, of Geneva, said its gamma-aminobutyric acid B (GABA-B) receptor positive allosteric modulator, ADX71441, caused dose-dependent changes in growth hormone (GH) plasma concentrations compared to vehicle control in a rodent preclinical model. The data were consistent with published scientific literature demonstrating that GABA, the endogenous neurotransmitter for GABA-B receptors, plays both a stimulatory and inhibitory role in modulating the neuroendocrine regulation of GH
Late Monday, Pfizer Inc. disclosed its decision to halt a Phase III trial (B1931008) of inotuzumab ozogamicin, an investigational antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting CD22, administered in combination with Rituxan (rituximab, Roche AG and Biogen Idec Inc.), in relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma (NHL). New York-based Pfizer said it would discontinue development of the drug in NHL after an independent data monitoring
By Marie Powers | BioWorld Today | Wednesday, May 22, 2013
The growth equity arm of Novo A/S has clocked up its first major pharmaceutical investment, a $700 million buyout of generic antibiotics developer and manufacturer Xellia Pharmaceuticals AS, under a new investment strategy it formulated more than a year ago. The deal exemplifies Hellerup, Denmark-based Novo's intentions to build large-scale, long-term positions in mature, low-risk companies. That represents a shift from its original strategy, involving earlier-stage companies approaching
By Cormac Sheridan | BioWorld Today | Wednesday, May 22, 2013
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Naloxegol is a peripherally acting mu-opioid receptor antagonist in development for opioid-induced constipation. Data were presented at the Digestive Disease Week conference in Orlando, Fla. Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported that tiotropium
Acadia Pharmaceuticals Inc., of San Diego, completed its public offering of 9.2 million shares, including 1.2 million shares sold to cover overallotments, priced at $12.50 per share, for gross proceeds of $115 million. Funds will be used to support ongoing and new clinical trials and development and commercialization of Parkinson's psychosis drug pimavanserin and for general corporate purposes. Epizyme Inc., of Cambridge, Mass., set terms for its proposed initial public offering (IPO), aiming
The Cell Therapy Catapult, which focuses on the development of the UK cell therapy industry, said it will work with London-based GlaxoSmithKline plc to explore potential collaborations in a range of areas relevant to the development of cell therapies, from research projects to technical and regulatory strategy. GSK is developing a bone marrow-derived stem cell gene therapy through late phase development and has a small number of collaborations in that field.