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...Ventrus has started to enroll in its second Phase III pivotal trial, with results expected early fourth quarter 2013, and assuming a successful outcome, expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014

Bristol-Myers Squibb Co., of New York, said the National Institute of Health and Clinical Excellence decided to recommend Yervoy (ipilimumab), which is approved in Europe for treating advanced metastatic melanoma, within the final appraisal determination...That decision will enable eligible patients in England and Wales to routinely access treatment with Yervoy through the National Health Services

ACP-501 is designed to replace the missing enzyme in FLD patients with a goal of restoring normal kidney function...The FDA is not obligated to follow the advice of its advisory panels but generally does so...Isis also remains eligible to receive milestone and royalty payments under its licensing agreement with Excaliard for EXC 001. (See BioWorld Today, Nov. 23, 2011

The firm anticipates peak annual sales to exceed $200 million...The 80,000-square-foot expansion is expected to be completed in March 2014 and is intended to manufacture insulin cartridges to meet the growing diabetes demand in the U.S...Health Canada had asked Novartis to suspend distribution of Agriflu and Fluad late last month as a precautionary step

Cialis for once-daily use was approved to treat erectile dysfunction (ED) in Europe in 2007...The FDA also approved Cialis 5 mg for once-daily use to treat men who have both ED and BPH...Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA accepted for review two supplemental new drug applications for use of atypical antipsychotic Latuda (lurasidone) as monotherapy and as adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with

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

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...Complix has data showing that CPABs are able to act on intracellular targets, and are effectively taken up by tumor cells...Idera Pharmaceuticals Inc., of Cambridge, Mass., reported data from preclinical studies showing selective inhibition of Toll-like

AmVac said it expects to begin clinical trials before the end of 2013...PV-10 is Provectus' oncology drug candidate designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects...A subdermal implant, Probuphine is designed to deliver six months of buprenorphine hydrochloride following a single treatment

Watson said it intends to review possible options related to the continued pursuit of the NDA...TSR-026, to date, has been developed through Small Business Innovation Research funding from the National Institute of Allergy and Infectious Diseases

The company said its objective is to advance Entolimod to licensure under the FDA's animal rule as soon as possible...The FDA requested studies to explore the safety profile of Oxycyte because perfluorocarbon emulsions as a class have been shown to cause transient thrombocytopenia in animals and humans, and have raised questions regarding potential impact of perfluorcarbon emulsions on normal immune system functions

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

Forest Laboratories Inc., of New York, said it inked a deal with moksha8, of Sao Paolo, Brazil, providing Forest with a commercial footprint in Latin America and giving moksha8 access to antidepressant drug Viibryd (vilazodone) and potentially other Forest products for the Latin American market...Terms call for Forest to provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals

Cellectis SA, of Paris, said its subsidiary, Cellectis bioresearch, was awarded a second contract to provide services to the National Institutes of Health and certain other government agencies...The test is in development to detect the presence of TRPV6 messenger RNA, a biomarker identified as being present in many epithelially derived cancers...Soricimed was formed to take discoveries made for peptide soricidin and transform them into a therapeutic and diagnostic pipeline. (See BioWorld Today, Oct. 1

Alnylam Pharmaceuticals Inc., and Genzyme Corp., a unit of Sanofi SA, both of Cambridge, Mass., formed an alliance to develop and commercialize RNAi therapeutics targeting transthyretin for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries...inked an agreement to co-develop cancer drugs based on methionine enkephalin (MENK), to be marketed in China under the brand names IRT-101 and IRT-102

Abbott, of Abbott Park, Ill., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for anti-TNF therapy Humira (adalimumab) for the treatment of pediatric patients, ages 6 to 17, with severely active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy...Sanofi Pasteur MSD, of Lyon, France, a unit of Sanofi SA, said it plans to license and commercialize a 6-in-1 pediatric vaccine in its European territories...The

EpiCept Corp., of Tarrytown, N.Y., said MidCap Financial LLC, pursuant to the amendment to the loan and security agreement dated Aug. 7, agreed to a one-month extension of the deadline to Nov. 15 for the signing of a definitive agreement with respect to a sale of the company or a partnering transaction for topical analgesic product AmiKet...Nabi and Biota inked the deal to merge in April, and amended the terms in September

Eli Lilly and Co., of Indianapolis, said the FDA approved the label inclusion for Alimta (pemetrexed) with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting for patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer following first-line Alimta plus cisplatin. Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said it filed a supplemental biologics license application

The results included a four-fold higher in vitro activity compared to azithromycin against Neisseria gonorrhoeae, more potent anti-inflammatory activity than other macrolides and similar or greater potency compared to erythromycin, clindamycin and telithromycin against community-acquired bacterial pneumonia...In eight-week- to 10-week-old male mice, those that received Bleomycin plus PLX cells administered into the trachea showed a statistically significant improvement in oxygen saturation

Bristol-Myers Squibb Co., of New York, said the FDA approved an update to the labeling for Baraclude (entecavir) to include data on African-Americans and liver transplant patients with chronic hepatitis B infection...Watson Pharmaceuticals Inc., of Parsippany, N.J., and Actavis Group, of Zug, Switzerland, are being required by the Federal Trade Commission to sell the rights and assets to 18 drugs to Sandoz International GmbH, a unit of Basel, Switzerland-based Novartis AG, and Par Pharmaceuticals