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

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...Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA has granted orphan drug designation to XEN402 to treat pain associated with erythromelalgia, a rare autosomal dominant condition characterized by burning pain in the

Covis Pharma Sarl, of Zug, Switzerland, inked a deal with affiliates of Paris-based Sanofi SA to acquire full commercial rights to Nilandron (nilutamide), Plaquenil (hydroxychloroquine), Rilutek (riluzole), Uroxatral (alfuzosin hydrochloride) and Kayexalate (sodium polystyrene sulfate) in the U.S. Sanofi will retain rights to the products outside of the U.S. Financial terms were not disclosed...In other news, Prana reported that it received a A$2.5 million (US$2.6 million) cash refund under the R&D

Furiex inked the deal with Menarini in 2012, giving the Italian pharma firm rights to commercialize Priligy in Europe, most of Asia, Africa, Latin America and the Middle East...The refund was received to support research and clinical development of PBT2 for Huntington's and Alzheimer's diseases, as well as for other Prana research activities into Parkinson's disease and other neurological indications

A.P. Pharma Inc., of Redwood City, Calif., received a complete response letter from the FDA regarding the new drug application for APF530 for the prevention of chemotherapy-induced nausea and vomiting...In other news, SCT closed its previously announced private placement for gross proceeds of C$3.2 million (US$3.1 million

Acceleron Pharma Inc., of Cambridge, Mass., said the FDA granted orphan designation for ACE-536 for the treatment of beta-thalassemia and for the treatment of myelodysplastic syndromes...Other candidates currently undergoing tests required for investigational new drug applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria and yellow fever...Plasma-derived C1 esterase inhibitor is an orphan drug approved by the FDA to treat or prevent

Another $13 million to $15 million in equipment, integration service and testing will be provided by Agila...Cardiome Pharma Corp., of Vancouver, British Columbia, said Institutional Shareholder Services Inc...Proteo Inc., of Irvine, Calif., said the FDA granted orphan drug designation to Elafin for the prevention of inflammatory complications of transthoracic esophagectomy

GenSpera Inc., of San Antonio, said the FDA granted orphan drug designation to G-202 for the treatment of hepatocellular carcinoma...In other news, law firm Bronstein, Gewirtz & Grossman LLC, of New York, said it is investigating claims on behalf of purchasers of Spectrum securities, after shares (NASDAQ:SPPI) fell as much as 38 percent on March 13 on news that the company slashed its revenue projections for colon cancer drug Fusilev (levoleucovorin

Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease...ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology

ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology...Proteologics Ltd., of Rehovot, Israel, and Newcastle Innovation Ltd., the technology transfer company of the University of Newcastle, Australia, entered an exclusive license agreement to develop and commercialize therapeutics for respiratory and other diseases based on the target Midline-1, an E3 ubiquitin ligase...SOV Therapeutics Inc., of Morrisville, N.C., said the

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

Osiris Therapeutics Inc., of Columbia, Md., reported that the European Medicines Agency granted orphan drug status to Prochymal (remestemcel-L) as a treatment of acute graft-vs.-host disease (GvHD...and six other countries under an expanded access program...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported that the FDA accepted for review a new drug application for lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, for the treatment of

patents relating to Exalgo to sell Actavis' 32-mg product beginning May 15, 2014...Eisai Inc., of Woodcliff Lake, N.J., said the FDA granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer...16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009

OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2

Apogenix GmbH, of Heidelberg, Germany, said the FDA granted orphan drug designation to Apocept, a drug designed to bind to the CD95 ligand and block activation of the CD95 receptor, in myelodysplastic syndromes (MDS

Apogenix GmbH, of Heidelberg, Germany, said the FDA granted orphan drug designation to Apocept, a drug designed to bind to the CD95 ligand and block activation of the CD95 receptor, in myelodysplastic syndromes (MDS...Zealand Pharma A/S, of Copenhagen, Denmark, said it was notified that licensing partner Sanofi SA, of Paris, will delay development of a program combining recently approved Lyxumia (lixisenatide) with Sanofi's Lantus (insulin glargine), owing to a technical issue encountered during

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market...Under the terms, Bio-Link will work with Phylogica to monetize those assets through out-licensing or disposal of the Phylomer peptides to a pharma or biotech company...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it engaged Citigroup to assist

The FDA granted orphan drug designation to the product for retinitis pigmentosa

The European Medicines Agency assigned orphan drug status to Prosensa's two preclinical compounds PRO052 and PRO055, and the FDA granted orphan drug status to the company's four compounds, PRO045, PRO052, PRO053 and PRO055