Although Galapagos NV is best known for its whopper of an alliance with AbbVie Inc. for its JAK inhibitor, GLPG0634, the company's rapidly growing drug discovery services business is set to expand further in 2013, following the acquisition of Cangenix Ltd., a UK-based specialist in structure-based discovery, and the establishment of its Fidelta unit in Croatia as an externally focused services arm. Mechelen, Belgium-based Galapagos is paying £1 million (US$1.6 million) up front for Canterbury

SAN FRANCISCO – With an established reputation for its generic drugs, Mumbai, India-based Lupin Ltd. has expanded into biosimilars in its quest to become a global biopharma powerhouse. But like the foggy view from the 32nd-floor penthouse location of the Asia track at the J.P. Morgan Healthcare Conference last week, the firm's chief financial officer provided limited insight into the company's biosimilars strategy despite audience questions. The same held true for another biosimilars developer

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults. Mirabegron is a once-daily oral beta3-adrenoceptor agonist, and it's designed to work by stimulating the beta3 receptors in the muscle of the bladder, causing relaxation of the bladder muscle, improving the storage capacity of the bladder without impeding bladder voiding. Drug discovery company Biotica Technology Ltd., of Cambridge, UK, a specialist

LONDON – Mesoblast Ltd. is preparing to discuss plans for Phase III development with regulators and weighing the partnering strategy after reporting positive Phase II results for its Neofuse cell therapy for treating degenerative disc disease by lumber spinal fusion. "We have scoped the Phase III and after multiple meetings with the FDA on other indications, we understand the general requirements for cell therapy trials," CEO Silviu Itescu told BioWorld International. He added he is "quite

LONDON – The plan to introduce value-based pricing of drugs in the UK in January 2014 lacks clarity, with the arrangements for the new system still not agreed on and companies that will have to work with the new arrangements uncertain about what they will mean in practice. A number of key decisions about the new system need to be taken before the end of March to ensure a smooth changeover from the current regime, in which drugs are priced on a cost-plus formula, to pricing based on an

LONDON – An unexpected finding about how tadpoles control the regeneration of a tail that has been lost will trigger new research into healing and regeneration of wounds and tissues in humans. The discovery challenges the perceived wisdom about the role of reactive oxygen species (ROS) – chemically reactive molecules containing oxygen, such as hydrogen peroxide and oxygen ions – which is that they are damaging to cells. Yet from the latest study, it appears that ROS such as hydrogen peroxide

ISA Pharmaceuticals BV raised €8 million (US$10.5 million) in an internal financing round to fund a Phase II trial of its therapeutic vaccine for cervical cancer, ISA-HPV. The vaccine is based on the company's synthetic long peptide (SLP) technology, which was originally developed by Cornelius Melief at Leiden University Medical Center (LUMC) in the Netherlands. It already completed a Phase II trial in vulvar intraepithelial neoplasia (VIN), a precancerous condition also caused by human

LONDON – For a healthy pregnancy to have the best chance of surviving, the cells lining the uterus must undergo a short-lived burst of inflammatory activity about five days after ovulation, which must come to a halt 48 hours later, researchers have found. The discovery suggested new ways of treating women who suffer recurrent miscarriages. A pilot randomized controlled trial in which women who previously had several miscarriages were treated with an anti-inflammatory drug or with a placebo

Actavis Inc., of Zug, Switzerland, recently acquired by Watson Pharmaceuticals Inc., of Parsippany, N.J., filed an abbreviated new drug application (ANDA) with the FDA for bortezomib, a generic version of Millennium: The Takeda Oncology Co.'s Velcade, a drug approved for multiple myeloma. Millennium filed a suit against Actavis on Dec. 21 in the U.S. District Court of Delaware to prevent Actavais from commercializing its bortezomib before expiration of some patents. The lawsuit filing includes

LONDON – arGEN-X BV is making strides in the commercialization of its antibody platform, announcing an extension of its existing collaboration with Shire plc in rare diseases and at the same time advancing the lead in-house program into a Phase Ib first-in-man trial. The partnership with Shire began in March 2012, using arGEN-X's Simple (Superior Immunodiversity with Minimal Protein Lead Engineering) technology to discover antibodies with the potential to achieve orphan drug status. Based on

LONDON – Heptares Therapeutics Ltd. convinced another partner of the power of its G protein-coupled receptor (GPCR) technology, sealing a deal with Cubist Pharmaceuticals Inc. around one – or possibly two – targets to be nominated by the quoted U.S. biotech. The full terms of the deal were not made public, but Heptares will receive $5.5 million up front and about $4 million in research funding for the first target, with milestones and royalties to follow if a program moves forward. Malcolm Weir

Undeterred by the recent string of high-profile failures in the field, Kareus Therapeutics SA moved its first-in-class drug candidate for Alzheimer's disease, KU-046, into a Phase I trial in healthy volunteers. The company, based in La Chaux-de-Fonds, Switzerland, is taking a novel approach to the condition by focusing on events upstream from the deposition of amyloid beta (Abeta) peptide, which is considered one of the pathological hallmarks of the disease. It is testing a hypothesis that

LONDON – After landing the all-important validation of a deal with GlaxoSmithKline Biologicals (GSK) in December, GlycoVaxyn AG is expecting to finalize an agreement to fund development of its lead in-house program and seal further collaborations around its conjugated vaccine technology platform in 2013. Vaccines development and manufacture is a small world, explained GlycoVaxyn CEO Philippe Dro. "A biotech like us can make contact with most of the players in the field, and the research teams

LONDON – A candidate drug that has previously been evaluated as a treatment for stroke turns out to be able to kill some types of pathogenic bacteria, an international team of researchers has found. As the mechanism of action identified is completely different to those used in current antibiotics, it may be possible to develop new types of antibiotics to treat multidrug-resistant bacteria, the researchers said. Arne Holmgren, professor of biochemistry at the Karolinska Institute in Stockholm

LONDON – More than 40 years after it was first proposed, a single European patent will come into effect on Jan. 1, 2014, after a compromise deal was endorsed last month. The new patent will be cheaper and more effective in protecting intellectual property (IP), with one patent grant covering the 25 countries that are committed to joining the system. The European Commission estimated that obtaining a patent under the unitary scheme will cost €4,725 (US$6,245), compared to the current average

AstraZeneca plc, of London, and CytImmune Sciences Inc., of Rockville, Md., entered an agreement to study the feasibility of a new cancer nanomedicine that will bind an oncology compound from AstraZeneca to CytImmune's CYT-6091 nanomedicine platform. CYT-6091, which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute in a Phase I trial in advanced-stage cancer

In the six decades since Watson and Crick discovered the structure of DNA, rarely has a year passed in the biopharmaceutical sector which could be defined as boring. The scientific revelations continue to yield intellectual property for businesses to develop. And investors scramble to identify and back potential blockbuster targets. 2012 was no different. BioWorld's editorial team huddled and voted on the 10 most poignant stories which emerged. Drum roll, please . . . 1. At Pharma's Long-Dreaded

LONDON – In a discovery that has important implications for the future of HIV therapy, an international team of researchers has identified the molecule by which the virus enters the immune cells known as dendritic cells. Those cells, which have a role in antigen presentation, are known to pick up HIV and deliver it to the virus' main target, the CD4-positive T cells. The latter become infected, instead of killing the virus. Now scientists from the AIDS Research Institute IrsCaixa in Barcelona

Top-line data from three Phase III trials of simeprevir (TMC435) in patients with hepatitis C virus (HCV) genotype 1 infection appear to confirm what Medivir AB has always maintained – that it has a potentially best-in-class protease inhibitor on its hands. In two trials in treatment-naive patients, QUEST-1 (n = 394) and QUEST-2 (n = 391), simeprevir, administered once daily in combination with pegylated interferon and ribavirin (Peg/Riba), achieved sustained virologic response 12 weeks after