To maintain consistency among study protocols, Pluristem also placed the Phase II IC study at Germany's Paul-Ehrlich-Institute on hold. (See BioWorld Today, June 5, 2013...The transfer is expected to take place over seven years, giving Fiocruz the authority for the Brazilian government to construct its own manufacturing facility and produce a sustainable supply of Uplyso, marketed in the U.S...Fiocruz agreed to purchase a minimum of $40 million of Uplyso during the first two years of the agreement and
T3D expects to reposition DB959 as a central nervous system therapy, using its neuroprotective potential to address multiple Alzheimer's disease pathologies, including neuroinflammation, neuronal cell loss, neurotransmitter deficits, tau neurofibrillary tangles and insulin resistance/lowered cerebral glucose metabolism...commercial rights to Bionect (hyaluronic acid sodium salt, 0.2 percent) in oncology markets from Innocutis Holdings LLC to concentrate on niche products for oncology and oncology
In othernews, Celgene said the European Commission amended the marketing authorization application for Revlimid (lenalidomide) so that it is now approved to treat patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate
Specifically, the partnership will focus on clinical trialsto test combinations of immunotherapies, including two investigational drugs from Immune Design's pipeline...That is in contrast to some other antibiotics, such as linezolid (Zyvox), which causes drug interactions when taken with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors...Zealand Pharma A/S, of Copenhagen, signed a collaboration agreement with D.E. Shaw Research LLC., of New York, to combine Shaw
In othernews, Biolinerx said it signed an out-licensing agreement with Jiagsu chia-tai Tianqing Pharmaceutical Co...Proceeds will 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
according to the protocol, all patients were to have been treated with both bortezomib and lenalidomide prior to study entry...Based on the positive results GSK said it is planning to make regulatory submissions in Europe, the U.S., as well as other regions during the next few
If approved, Lojuxta will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH...according to the protocol, all patients were to have been treated with both bortezomib and lenalidomide prior to study entry
plc, of Dublin, Ireland, said its board rejected New York-based Royalty Pharma's revised offer to acquire all of Elan's shares for $12.50 per share through its shell subsidiary Echo Pharma Acquisition Ltd., stating that the bid "grossly" undervalued the company...In othernews, Elan priced its offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021 by its wholly owned subsidiaries, Elan Finance public limited co
In addition to RA and Crohn's, the pharma may develop GLPG0634 in psoriasis, irritable bowel syndrome and lupus, mirroring the path by which the label on its blockbuster Humira (adalimumab) was expanded beyond RA...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
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
plc, of Dublin, Ireland, published a response to an offer made by Echo Pharma Acquisition Ltd. (Royalty Pharma) on May 2...to produce and supply 123I-labeled NAV5001 for Navidea's late-phase clinical trials
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
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 International Inc., of Montreal...The big pharma firm stated that it has opted to prioritize the fixed-ratio combination of Lantus
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 othernews, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma
BioWorld International | Wednesday, April 24, 2013
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
To maintain consistency among study protocols, Pluristem also placed the Phase II IC study at Germany's Paul-Ehrlich-Institute on hold. (See BioWorld Today, June 5, 2013...The transfer is expected to take place over seven years, giving Fiocruz the authority for the Brazilian government to construct its own manufacturing facility and produce a sustainable supply of Uplyso, marketed in the U.S...Fiocruz agreed to purchase a minimum of $40 million of Uplyso during the first two years of the agreement and