The FDA acknowledged receipt of a new drug application for Eliquis in September and deemed it a complete response to its June 22 complete response letter requesting additional information on data management and verification from the ARISTOTLE trial

Without admitting or denying allegations, Lilly consented to pay a civil settlement of $29.4 million and agreed to have an independent compliance consultant conduct a 60-day review of the company's internal controls and compliance program related to the FCPA...As part of the settlement, Sanofi agreed to pay $109 million to the settling parties and expects to enter a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services

Allergan Inc., of Irvine, Calif., said it completed the acquisition of SkinMedica Inc., of Carlsbad, Calif., for about $350 million.

Flutemetamol, an investigational positron emission tomography imaging agent, to support Merck's development of MK-8931, an oral, beta-amyloid precursor protein site cleaving enzyme inhibitor in development for Alzheimer's disease...Shire plc, of Dublin, Ireland, reported a positive outcome from the European Decentralised Procedure for Elvanse (to be known as Tyvense in Ireland), indicated as part of a comprehensive treatment program for attention-deficit hyperactivity disorder in children, ages 6

The alliance will involve researchers from both organizations working together to investigate new ways of treating neurological diseases such as Alzheimer's, Parkinson's and other related disorders...The goal will be to identify and validate drug targets, develop new therapeutics and evaluate them in proof-of-concept trials

Galderma Pharma SA, of Lausanne, Switzerland, agreed to acquire Spirig Pharma AG, of Egerkingen, Switzerland

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

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

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.

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...Following completion of those programs, the pharma firm will have an exclusive option to license rights in exchange for development and commercial milestones payments and royalties

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