The product is licensed from Cipher Pharmaceuticals Inc., of Mississauga, Ontario, and was formulated in such a way that it does not need to be given with a high-fat meal, as is usually the case with isotretinoin

Novartis AG, of Basel, Switzerland, gained FDA approval of Flucelvax, described as the first cell culture-derived seasonal flu vaccine cleared for marketing in the U.S. The vaccine was approved for adults 18 years old and older.

Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, said the European Committee for Medicinal Products for Human Use granted a positive opinion recommending approval of Zytiga (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically

The acquisition is set to close later this year and is expected to complement Allergan's existing facial aesthetics business, which includes Botox Cosmetic, Juvederm and Latisse...Allergan said it expects to operate SkinMedica as a separate global business

Earlier this year, Janssen and nine other companies joined forces to create TransCelerate BioPharma Inc., an initiative aimed at identifying and overcoming common drug development challenges to improve the quality of clinical studies. (See BioWorld Today, Sept. 26, 2012

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and BaroFold Inc., of Aurora, Colo., said they entered a nonexclusive technology and commercial license option agreement, in which Boehringer will acquire a laboratory-scale reactor of BaroFold's Pressure Enabled Manufacturing Technology (PreEMT) that can also be qualified for GMP use. PreEMT will be available for development of biopharmaceutical production processes. Financial terms were not disclosed.

Foundation Medicine Inc., of Cambridge, Mass., and AstraZeneca plc, of London, signed a multi-year collaboration to identify alterations found in cancer-related tumor genes that may predict a person's response or resistance to targeted medicines...Foundation Medicine also was granted right of first negotiation to develop potential diagnostic products from the collaboration...Janssen plans to discontinue the Prezista 400-mg tablet

The company said the FDA has not informed them of when it expects to complete the review of the NDAs for the products

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75 mg due to a potential packaging defect that may compromise the bottle integrity...A damaged bottle could allow moisture to get into the bottle, which may impair the quality of Pradaxa

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

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

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

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

A.P. Pharma Inc., of Redwood City, Calif., said the FDA accepted the company's resubmission of a new drug application for APF530, a long-acting formulation of granisetron in development for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting...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

Biostar Pharmaceuticals Inc., of Xianyang, China, said it signed a one-year agreement valued at about $3 million to manufacture and supply Xijing Hospital with five additional drugs...Watson Pharmaceuticals Inc., of Parsippany, N.J., said it received approval for its abbreviated new drug application for Trospium Chloride Extended-release Capsules, the generic equivalent to Irvine, Calif.-based Allergan Inc.'s Sanctura XR...Watson said it intends to begin immediately shipping the product, which is

Roche AG, of Basel, Switzerland, lost its appeal in the federal circuit to get a preliminary injunction against generic formulations of its bisophosphonate Boniva (ibandronate) for the treatment of osteoporosis

The grant will award up to €1 million (US$1.3 million) annually to fund innovative academic research in MS...and Canada and by Merck Serono to those based elsewhere

Aeras, a vaccine development company, said it signed a deal with London-based GlaxoSmithKline plc's vaccines division to jointly develop an investigational tuberculosis vaccine containing GSK's M72 antigen and AS01E adjuvant...Versant will provide equity financing to the company, and Roche will fund the research based on a series of milestones...Roche retains an exclusive option to acquire Inception 3 upon a first lead compound reaching the filing stage of an investigational new drug application

The goal is to identify specific genomic alterations in each patient's tumor and use the results to inform patient stratification, guide drug development decisions and potentially for commercialization of new molecular diagnostics...The project-based collaboration will include both preclinical and clinical translational research to elucidate questions from proof of concept to tolerability, efficacy and effectiveness