Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin

Acceleron Pharma Inc., of Cambridge, Mass., said Shire plc, of Dublin, Ireland, concluded the firms' collaboration on ACE-031 and related molecules...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

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...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

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee

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...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Ocera Therapeutics Inc., of San Diego, entered a definitive agreement under which Ocera will merge with a subsidiary of Tranzyme in an all-stock transaction

Armgo Pharma Inc., of Tarrytown, N.Y., and the Muscular Dystrophy Association (MDA) said $1 million was awarded for preclinical work in support of an investigational new drug application for AMR201, an oral, small-molecule Rycal drug that has the potential to treat Duchenne's muscular dystrophy

NovaDel Pharma Inc., of Bridgewater, N.J., signed a definitive agreement to sell its NovaMist technology and certain additional assets, including related patents and trademarks, to Australia's Suda Ltd

DFH Pharma Inc., of Gaithersburg, Md., said it entered a research and product development agreement with Hetero Group, a research-based pharmaceutical group headquartered in Hyderabad, India, to develop next-generation HIV maturation inhibitor drugs...Tris Pharma Inc., of Monmouth Junction, N.J., said the FDA approved its new drug application for Karbinal ER (carbinoxamine maleate) extended-release oral suspension, a sustained-release histamine receptor blocking agent indicated for the treatment of

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

Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus...In other news, The Nasdaq OMX Stockholm's listing committee approved the listing of NeuroVive's shares

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

Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus

TransTech Pharma Inc., of High Point, N.C., said the FDA granted fast-track designation for TTP488, a small-molecule chemical compound in development to treat Alzheimer's disease (AD

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is set to close with Weston, Mass.-based Biogen Idec Inc

Cubist Pharmaceuticals Inc., of Lexington, Mass., and Astellas Pharma Inc., of Tokyo, said they entered an agreement under which Cubist obtains the rights to ceftolozane in certain Asia-Pacific and Middle East territories from Astellas...Tris Pharma Inc., of Monmouth Junction, N.J., said it received the first milestone payment under its U.S

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency...Eisai Inc., of Woodcliff Lake, N.J., reported that the German Federal Joint Committee said it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments