Without revealing much in the way of new data, TopoTarget A/S enjoyed a 45 percent bounce in its share price during early trading Tuesday, as an analysis of the final top-line results from a registration trial of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) confirmed the drug exceeded the efficacy level defined by the study's primary endpoint, a minimum objective response rate (ORR) of 20 percent. The threshold had been agreed on with the FDA under the

LONDON – Ablynx NV raised €31.5 million (US$41 million) in a private placement, boosting cash reserves to around €90 million and allowing the company to progress development of its next-generation rheumatoid arthritis (RA) product ALX-0061 into Phase IIb, while negotiating with potential partners. The placement of 4.4 million new shares was via an accelerated book-building process, announced after the market closed on Feb. 27 and completed on Feb. 28. The shares were placed at €7.20 per share

Addex Therapeutics SA, of Geneva, and Viva Biotech Ltd., of Shanghai, China, entered a partnership to advance oral small-molecule adenosine 2A receptor (A2AR) positive allosteric modulators. The A2AR natural ligand, extracellular adenosine, is locally produced at the sites of inflammation and has been characterized for decades as a "brake for inflammation." An oral small-molecule compound targeting A2AR activation, which selectively enhances the effect of high adenosine concentration only

Privately held Concert Pharmaceuticals Inc. struck another business development high note, inking an exclusive license agreement that provides Jazz Pharmaceuticals plc with global rights to develop and commercialize deuterium-modified sodium oxybate (D-SXB) compounds, including C-10323, aimed at narcolepsy. Sodium oxybate is the active ingredient in Xyrem, which Jazz markets in the U.S. to treat the narcolepsy symptoms cataplexy and excessive daytime sleepiness. Concert's preclinical data

LONDON – The European Commission (EC) finally put some financial firepower behind its pledge to find treatments for 200 rare diseases by 2020, announcing €144 million (US$187 million) of new funding for 26 separate projects. Those projects will bring together more than 300 participants from 29 countries across Europe and the U.S., including academics, biotechs and patients' groups. A spectrum of rare diseases, ranging from cardiovascular to metabolic and immunological disorders will be covered

LONDON – A new genetic study has provided backing for the theory that inflammation in the brain is a cause of psychosis. Researchers in Sweden have discovered that a genetic variant that boosts the effects of inflammation in the brain is more common in people with bipolar disorder who experience psychotic episodes. The finding is likely to lead to exploration of new therapeutic strategies for the treatment of bipolar disorder and schizophrenia, using anti-inflammatory drugs. Catharina

LONDON – Start-up BioMoti Ltd. secured its first private financing in a seed round of £150,000 (US$227,000) to advance its Oncojan platform technology, a microparticle carrier system combining targeted delivery of chemotherapy drugs with their controlled release within tumor cells. When added to £350,000 in nondilutive grant funding received to date, that will allow the London-based company to shape up the technology, develop the business plan and move to raising a Series A of up to £12 million

LONDON – Identification of a protein that orchestrates many of the changes that permit a normal cell to turn into a cancer cell will open up an entirely new field of cancer therapeutics, the researchers who made the discovery predicted. The team, from ICREA in Barcelona, Spain, also established a screening system to identify compounds that will inhibit the protein. Raùl Méndez, group leader at the Institute for Research in Biomedicine in Barcelona, told BioWorld International: "We have found

The lineaments of Ireland's new science strategy are evident in its latest round of research funding, comprising €200 million (US$261 million) of public money, which will fund seven university-industry research centers over the next six years. Industry partners will add another €100 million through a mix of cash and in-kind contributions. Although three of the seven centers are focused on life sciences – and a fourth has a significant life sciences strand – none will perform discovery research

LONDON – Biotechs registered with the SME (small- and medium-sized enterprise) Office of the European Medicines Agency (EMA) have seen consistent improvements in the success rate of applications for marketing approvals, according to a report analyzing activity in the seven years since the office was set up in 2005. In that time, 98 marketing authorization applications (MAAs) were made by SMEs, of which 26 currently are under evaluation. Of the remainder, just over half were successful. That is

4SC AG could earn up to €96 million (US$125 million) in option and milestone payments arising out of a preclinical drug development deal in inflammatory skin disease with Leo Pharma A/S, as well as double-digit royalties on eventual product sales. 4SC is getting a €1 million option fee up front and would receive another €3 million should Leo, of Ballerup, Denmark, exercise its option. Another €92 million is available in development milestones. 4SC also will receive R&D funding. The companies

Ablynx NV, of Ghent, Belgium, and Spirogen Ltd., of London, inked a research collaboration to evaluate the potential of a cancer drug conjugate combining Spirogen's cytotoxic drugs, pyrrolobenzodiazepines and associated linker technology, with Nanobodies generated using Ablynx's technology platform. Under the terms, Ablynx will provide access to Nanobodies against an undisclosed target, and Spirogen will provide access to its cytotoxic warheads and conjugation technologies. The collaboration

BOSTON – Research backed by the Armed Forces Institute of Regenerative Medicine (AFIRM) since its formation in April 2008 will within the next five years lead to a range of marketed products that, taken together, will vastly improve the treatment of severe facial injuries, reducing the amount of surgery required and providing superior structural, functional and aesthetic results. That is the view of Col. Robert Hale, of the U.S. Army Institute for Surgical Repair, who told attendees of the

Shares in Gentium SpA fell 20 percent last week on news that the lengthy approval process for defibrotide, a drug for the treatment and prevention of hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem cell transplant, had just become longer. Preliminary feedback, following an oral presentation to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), indicated the CHMP is likely to adopt a negative stance when it comes to a

DUBLIN, Ireland – Shares in Elan Corp. plc (NYSE:ELN) rose 5 percent to $11.14 Monday in response to an indicative $11 per-share takeover offer from Royalty Pharma. Although Dublin, Ireland-based Elan issued a critical response to the offer, which represents a 4 percent premium to its closing share price Friday, it was not an outright refusal. The investor response suggested there is an appetite in the market for an exit. The company is now in play. With the ink barely dry on its new post

BOSTON – Location, location, location: The idea that one gene equals one protein is long discredited and research into mechanisms including post-translational modification of proteins and the baroque complexities of epigenetic control is advancing understanding of how one gene can generate multiple proteins. Now an emerging area of science – looking at the spatial organization of the genome and how the physical location of a gene within the cell nucleus impacts on its expression and functioning

Following pressure from a group of dissident shareholders, Diamyd Medical AB agreed to return most of its cash to its investors, while retaining a small amount to continue two Phase II trials of its GAD vaccine for the treatment and prevention of Type I diabetes. "We were able to avoid liquidation of the company," Chairman Anders Essen-Möller, who holds 33.92 percent of the votes in the Stockholm, Sweden-based company, told BioWorld International. Rebel shareholders, representing about 30

Ablynx NV, of Ghent, Belgium, reported efficacy and safety data for its anti-IL-6R nanobody, ALX-0061, at the 24-week final analysis of the Phase II part of a Phase I/II study in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. The Phase II data showed ACR20, ACR50 and ACR70 scores of up to 100 percent, 75 percent and 63 percent, respectively, for patients who were consistently dosed at 3mg/kg Q4W over 24 weeks. At all doses tested, ALX

LONDON – 2013 will be a watershed year for biosimilars – biological therapies designed to be similar to existing biological therapeutic agents – delegates attending the Second Biosimilars Congregation in London heard Tuesday. While the European Medicines Agency (EMA) has not approved any new biosimilars since 2010, largely because of a lack of applications, it is now considering two license applications lodged in April and September of last year. Both are for infliximab, which is marketed as