After the dividend distribution, expected to be paid Jan. 1, 2013, AbbVie will be an independent, publicly traded company, and Abbott will retain no ownership interest...AbbVie common stock is expected to begin trading Jan. 2, 2013, on the New York Stock Exchange under the ticker "ABBV...The recall does not affect or related to the 80-mg dosage strength of the cholesterol-lowering drug

Abbott, of Abbott Park, Ill., said the European Commission approved Humira (adalimumab) for the treatment of pediatric patients, ages 6 to 17, with severe active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy

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

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

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.

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

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...Suvorexant is designed to target and block orexins, chemical messengers that help keep people awake

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

Results of a Mini-Sentinel assessment of Pradaxa (dabigatran etexilate mesylate, Boehringer Ingelheim GmbH) bleeding rate were not higher than those associated with new use of warfarin, according to the FDA...The agency investigated actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin using insurance claims and administrative data...Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need

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

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

Dainippon Sumitomo Pharma Co...The filing triggered a $5 million milestone payment to Sosei

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

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...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 hexavalent