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

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

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

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

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

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 backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it to continue growing because of the

Generic drugmaker Actavis Inc.'s plan to take over Dublin, Ireland-based Warner Chilcott plc in a stock-for-stock transaction worth about $8.5 billion, thus forming the world's third-largest specialty pharmaceutical firm, would put the combined firm – with about $11 billion in annual revenues – on even more solid footing in the busily consolidating biosimilars realm. "Due to the Irish takeover rules, there's very little we can say at the moment," Paul Bisaro, president and CEO of Actavis, told

Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter. Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of

For more than half a decade, researchers have understood translation to be a key step in gene expression, but it's only recently that drugmakers have begun looking at restoring translational control as a means of treating disease. "People thought of [translation] as the boring half of gene expression," said Steve Worlund, who co-founded and now serves as the president and CEO of Effector Therapeutics Inc., a recent start-up working to develop selective translation regulators. Translation is

Major depression affects more than 15 percent of the population at some point in their lives, and about 7 percent in any given year. Currently approved antidepressants are effective only about half the time – and even then, with a lag time of several weeks after a patient starts taking them. The time lag of antidepressant's effectiveness is something of a mystery. The effects of the newest generation of antidepressants, selective serotonin reuptake inhibitors (SSRIs) seem to be dependent on the

DUBLIN, Ireland – Elan Corp. plc continues to execute its M&A strategy at a dizzying pace, while its would-be acquirer, Royalty Pharma has tabled a revised offer for the company, worth $12.50 per share or $6.37 billion. On Monday, Elan unveiled an acquisition agreement with AOP Pharmaceuticals AG worth €263.5 million (US$339.3 million) in cash (€175.7 million) and shares (€87.8 million) initially – plus another potential €270 million in milestones – and a deal to acquire a 48 percent stake in

Shares of Xenoport Inc. (NASDAQ:XNPT) dropped almost to the bottom of their 52-week range early Monday, opening at $5.04 after the company terminated its late stage arbaclofen placarbil (AP, previously XP19986) program in spasticity due to multiple sclerosis (MS) after a pivotal Phase III trial failed to demonstrate statistically significant improvement compared to placebo. The stock lost $1.03 on the day, or 15.3 percent, closing at $5.72. The Santa Clara, Calif.-based company said it would

Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes. SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy. The study will