Baxter said it will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014...The program is expected to move into clinical trials within two years

Pursuant to the agreement, the company may from time to time sell up to a maximum of $20 million of the company's American Depositary Shares (ADSs...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories for marketing AAT product Glassia and for general corporate purposes

to produce and supply 123I-labeled NAV5001 for Navidea's late-phase clinical trials...NAV5001, manage the logistics and make arrangements for shipment of NAV5001 to third-party clinical trial sites on behalf of Navidea

Approval was supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments...The company plans to use proceeds to repurchase common stock and for general corporate purposes, including the repayment of outstanding commercial paper borrowings and upcoming debt maturities

Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy...Quintiles will also contribute to Merck Serono's future trial design process

filings, Merck's Canadian subsidiary transferred sponsorship of all vernakalant clinical trial applications to Cardiome...In separate news, Hyperion said it exercised its option to acquire Buphenyl (sodium phenylbutyrate) tablets and powder, an FDA-approved therapy for the chronic management of the most prevalent UCDs, and Ammonul (sodium phenylacetate and sodium benzoate) injection, a hospital-based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies

Ltd., of Tokyo, entered a clinical trial agreement under which Daiichi will support and co-sponsor a Phase I study of PER977 to reverse the anticoagulant activity of edoxaban...It does not bind to blood coagulation factors or other blood proteins

Addex Therapeutics, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...TheraCoat Inc., of Ra'anana, Israel, completed a safety and tolerability study and plans to commence efficacy clinical trials in two bladder indications

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments...Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies

Net proceeds will be used to complete a Phase II Squalamine eye drop clinical trial for the wet form of age-related macular degeneration, to further the clinical development of the eye drops for the treatment of other neovascular ophthalmic disorders, to fund development of other pipeline molecules, and for general corporate purposes

The EU Clinical Trials Register merely described the study, which was comparing Celltrion's CT-P10 to MabThera in patients with advanced follicular lymphoma at European trial sites, as "prematurely ended...The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data...In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

Bristol-Myers Squibb Co., of New York, will invest $250 million to expand its large-scale biologics manufacturing facility in Devens, Mass., introducing biologics development and clinical trial manufacturing capabilities and adding about 350 employees

In other news, GSK recently agreed to a nonexclusive material transfer, patent and know-how license deal with the Health Protection Agency (HPA) for the development and manufacture of a next-generation polio vaccine...Terms include certain milestones and tiered royalty payments to the HPA in return for technology transfer and other licensing rights

To be of any practical use at all, an antibody to HIV needs to be broadly neutralizing – that is, it needs to be able to bind to many different strains of HIV, as a single patient effectively ends up harboring dozens to hundreds of viral variant over the course of an infection...In the case of HIV, such affinity maturation turns out to be a longer process than for many other viruses...Editor's note: See Thursday's issue of BioWorld Today for more news on recent advances in HIV vaccine research

to explore strategic options for Stedivaze, a highly selective adenosine A2A agonist in development as a pharmacological stress agent for use in myocardial perfusion imaging...The company plans to use the funding to advance its vaccine candidate, designed to block transmission against malaria...The company's technology fuses candidate vaccine antigens from malaria to self-assembling proteins from the ciliated protozoan, Tetrahymena, to create nanometer-sized particles called G-Somes that have the