Eisai has a pending new drug application for Aciphex delayed-release sprinkle capsules 5 mg and 10 mg for the proposed indication of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children, ages 1 to 11

GlaxoSmithKline plc, of London, and the Fred Hutchinson Cancer Research Center entered a partnership to develop therapeutics to treat an inherited form of muscular dystrophy...The goal of the agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the disease

Reddy's Laboratories Ltd., of Hyderabad, India, acquired exclusive marketing and sales rights to Pamorelin LA (triptorelin) Depot, by Debiopharm Group, of Lausanne, Switzerland, in India for locally advanced or metastatic, hormone-dependent prostate cancer

Janssen Biotech Inc., of Horsham, Pa., and Janssen Biologics B.V., of Leiden, Netherlands, both part of Johnson & Johnson, submitted a supplemental biologics license application (sBLA) to the FDA and a Type II Variation to the European Medicines Agency (EMA) requesting approval of Stelara (ustekinumab) to treat adult patients with active psoriatic arthritis...The FDA gave guidance and permission to Lipocine Inc., of Salt Lake City, for its Phase III study of oral testosterone replacement therapy

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients

Ipsen SA, of Paris, and Galderma Pharma SA, of Lausanne, Switzerland, said they extended their collaboration for the promotion and distribution of Dysport, Ipsen's botulinum toxin Type A in aesthetic indications, renewing the deal in Brazil and Argentina and adding Australia where Galderma has the exclusive promotion and distribution rights for Dysport in the glabellar lines indication

Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for priority review Eisai's NDA for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of gastroesophageal reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age

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