LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated

In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013...Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S

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

Forxiga is the first SGLT2 inhibitor to gain approval in diabetes and is intended for use as an adjunct to diet and exercise in combination with other glucose-lowering products such as insulin or as a monotherapy in metformin-intolerant patients

Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7.1 showed promising safety and tolerability in heavily pretreated solid tumors...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals

The defendants AstraZeneca AB, AstraZeneca LP, AstraZeneca Pharmaceuticals LP and Aktiebolaget Hassle, all subsidiaries of AstraZeneca plc, of London, will pay up to $11 million with approximately half of the settlement fund going to pay consumer claims and the other half to pay insurers and employee welfare benefit plans claims...In April, the European Commission approved pasireotide under the brand name Signifor for the treatment of adult patients with Cushing's disease for whom surgery is not an

rights to market Bethkis (tobramycin inhalation solution) for the management of cystic fibrosis patients with Pseudomonas aeruginosa...XenoPort licensed worldwide rights, excluding Asian territories, to Horizant to GSK in 2007 for $75 million in cash up front, $65 million in milestones leading up to the filing of a new drug application and an additional $210 million in other development and regulatory milestones, plus as much as $290 million in sales milestones...Immune Pharmaceuticals Ltd., of

In addition to active involvement in the development of the monoclonal antibody, AET BioTech will provide additional investment in the biosimilar based on committed long-term financing and will oversee future commercialization of the product...IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...Protalix BioTherapeutics Inc., of Carmiel, Israel, and Pfizer Inc

The European Commission approved New York-based Bristol-Myers Squibb Co.'s Baraclude (entecavir) Summary of Product Characteristics update after reviewing new efficacy and safety data in patients with chronic hepatitis B following a liver transplant...Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood monitoring, and was approved for these three new indications on a priority review timeline

Cardiome Pharma Corp., of Vancouver, British Columbia, said Nasdaq granted the firm's request for an additional 180 days to regain compliance with the $1 minimum bid price requirement...Protalix BioTherapeutics Inc., of Carmiel, Israel, and Pfizer Inc., of New York, said the European Commission refused to grant the marketing authorization application for taliglucerase alfa, an enzyme replacement therapy for Gaucher disease, following a negative recommendation from the Committee for Medicinal

Eli Lilly and Co., of Indianapolis, said the European Commission approved Cialis (tadalafil) 5 mg for once-daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH...Cialis for once-daily use was approved to treat erectile dysfunction (ED) in Europe in 2007

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

Janssen-Cilag International, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved a 100-mg/mg oral suspension of Prezista (darunavir) and the use of the drug co-administered with low-dose ritonavir for the treatment of HIV-1 infection in antiretroviral therapy-experienced pediatric patients, ages 3 and older, weighing at least 15 kg...The filing triggered a $5 million milestone payment to Sosei

Pfizer Inc., of New York, said the European Commission gave conditional marketing authorization for Xalkori (crizotinib) for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer...The alliance will facilitate research on 13 undisclosed rare disease indications and has the potential to add candidates to Shire's early stage pipeline

Cytheris SA, of Paris, said the European Commission granted orphan drug status to CYT017 for progressive multifocal leukoencephalopathy (PML...In addition, they voted to approve a restated certificate of incorporation, a change of the company name from Nabi Biopharmaceuticals to Biota Pharmaceuticals Inc., a reverse stock split and issuance of shares of Nabi common stock to Biota stockholders

A final decision from the European Commission is anticipated in the next several weeks...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

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

AspenBio Pharma Inc., of Castle Rock, Colo., said it is proposing to change its name to Venaxis Inc...NovImmune SA, of Geneva, said the European Commission awarded a €6 million (US$7.8 million) FP7 grant to the "FIGHT HLH" consortium of institutions to support clinical testing of the company's anti-interferon gamma drug candidate, NI-0501