Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was

AlphaCore Pharma Inc., of Ann Arbor, Mich., said it received orphan designation from the European Medicines Agency for ACP-501 for familial LCAT deficiency (FLD), a rare, inherited condition that causes lipid accumulation in the eyes, red blood cells and kidneys

In other news, Cellectis said it signed two exclusive license agreements with Iowa State University granting the firm worldwide rights to inventions related to TAL effector-nucleases (TALENs) and monomeric TALENs...Pharma Two B Ltd., of Rehovot, Israel, completed a second round of financing for $8 million to develop its fixed-dose-combination product, P2B001, for Parkinson's disease and to complete a Phase IIb trial

Ltd., also of Osaka, said the European Medicines Agency confirmed the acceptance for review of the marketing application for atypical antipsychotic medication lurasidone, an oral, once-daily drug, for treating schizophrenia...The filing triggered a $5 million milestone payment to Sosei

BioAlliance Pharma SA, of Paris, said it signed a deal with Shafayab Gostar to distribute Loramyc (miconazole Lauriad mucoadhesive buccal tablet) in Iran for the treatment of oropharygeal candidiasis in immunocompromised patients...for turoctocog alfa, a third-generation recombinant coagulation Factor VIII intended for prevention and treatment of bleeding with people with hemophilia A. In other news, Novo Nordisk said the European Committee for Medicinal Products for Human Use adopted a positive

Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome...The hexavalent vaccine, aimed at protecting infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus

In other news, Almirall reported data from the MOVE 2 study supporting the use of Sativex, an endocannabinoid modulator, to reduce symptoms of moderate to severe spasticity due to multiple sclerosis

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., said the European Medicines Agency (EMA) agreed to permit registration of the Sufentanil NanoTab PCA System (ARX-01) via its centralized review process, enabling AcelRx to submit a single marketing authorization application for ARX-01 in all 27 European Union member states and four European Free Trade Association countries through a single evaluation by the Committee for Medicinal Products for Human Use...LEO Pharma A/S, of Ballerup, Denmark

In other news, Ablynx said it and partner Merck Serono, a division of Darmstadt, Germany-based Merck KGgA, advanced Nanobody candidate ALX-0751 into preclinical development in cancer...In other news, Boehringer and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Committee for Medicinal Products for Human Use for DPP-4 inhibitor Trajenta (linagliptin) in combination with insulin in adults with Type II diabetes...are soliciting consents from note holders for

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for approval of afatinib, an irreversible ErbB family blocker, as a treatment for patients with EGFR mutation-positive non-small-cell lung cancer...Lundbeck A/S, of Copenhagen, Denmark, said it submitted a marketing authorization application to the European Medicines Agency seeking approval of multimodal antidepressant vortioxetine (lu AA21004

The transaction now returns more cash to Nabi stockholders and provides increased certainty, through the use of a collar mechanism to protect against drops in the price of Biota shares...United Therapeutics Corp., of Silver Spring, Md., said under an exclusive agreement with Ascendis Pharma A/S, of Copenhagen, Denmark, it will apply Ascendis' TransCon technology platform to its treprostinil molecule, the active ingredient in Remodulin (treprostinil) injection for the treatment of pulmonary arterial

Merck KGgA, of Darmstadt, Germany, said it withdrew its application from the European Medicines Agency seeking to extend the use of cancer drug Erbitux (cetuximab) in non-small-cell lung cancer

In other news, BioLineRx said BL-7010, an oral candidate in celiac disease and gluten sensitivity, was found to be safe and well tolerated in preclinical studies presented at the Better Life for Coeliacs 2012 Conference in Helsinki, Finland...The company expects to submit a new drug application in PsA to the FDA in the first quarter of 2013 and a combined marketing authorization application in PsA and moderate-to-severe psoriasis to the European Medicines Agency in the second half of 2013

Biogen Idec Inc., of Weston, Mass., sold royalty and other undisclosed rights to Benlysta (belimumab) to a fund managed by DRI Capital, of Toronto...Cardiome Pharma Corp., of Vancouver, British Columbia, said the European Society of Cardiology updated guidelines for the treatment of adult patients with recent onset atrial fibrillation that include the intravenous formulation of Brinavess (vernakalant) and other treatments, when pharmacologic cardioversion is preferred, as first-line therapy for the

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB...Two months ago, Janssen submitted a new drug application for bedaquiline, under priority review, to the FDA

Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it submitted a marketing authorization application for ponatinib, its BCR-ABL inhibitor, to the European Medicines Agency to treat adults with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL...Piper Jaffray analyst Edward A. Tenthoff said in a research note that the news is "a likely positive" and he continues to expect Cabo approval by the PDUFA date

Astellas Pharma Inc., of Tokyo, disclosed plans to close subsidiary Urogenix Inc., of Durham, N.C., a research facility focused on urology drug discovery that was acquired in 2006 from Dynogen Pharmaceuticals Inc...In other news, GSK said it submitted applications in the European Union and the U.S...In other news, Pluristem said the life of a patient, a 54-year-old woman diagnosed with lymphoma cancer, suffering from bone marrow failure has been saved using Placental eXpanded (PLX) cells

In other news, Almirall and Quintiles Transnational Corp., of Durham, N.C., entered a long-term strategic partnership to promote Almirall's respiratory portfolio in the UK, strengthening the companies' existing relationship...In other news, Eisai published results from a pivotal Phase III study (Study 304) of Fycompa (perampanel), for partial-onset seizures, in subjects 12 and older showing that once-daily perampanel 8 mg or 12 mg improved seizure control, and that both doses were safe and well