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

BIT225 is designed to specifically target HIV in reservoir cells to stop the ongoing cycle of infection in the body...Those and other data were presented at the American Society of Hematology meeting in Atlanta

The HexaBody platform will be used to create differentiated antibody therapeutics, to improve the efficacy of existing antibody products and potentially to repurpose drug candidates that were unsuccessful in previous clinical trials due to lack of potency...The technology has the potential to enhance antibody therapeutics for a broad range of applications in cancer and infectious diseases, according to the company

Ltd., of Seoul, South Korea, agreed to establish a venture in South Korea under which Teva will contribute its global resources, with responsibilities for manufacturing and supplying a wide range of medicines, while Handok will handle sales and marketing, distribution and regulatory affiars...and Canada to Probuphine, a subdermal implant and a long-acting product designed to deliver six months of buprenorphine hydrochloride following a single treatment

The cornerstone of the initiative is the MMRF CoMMpass study, which is designed to follow 1,000 newly diagnosed multiple myeloma patients over five years to understand the molecular changes underpinning the progress of the disease...Vanda said it intends to appeal the opinion and request a re-examination of the CHMP decision

The company expects to receive about $725,200 after sales commission and other expenses...Under the 2010 collaboration, Genmab is tasked with creating human antibodies to three central nervous system targets identified by Lundbeck

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

The transaction is expected to close in early 2013...The single-tablet, combination regimen is designed to provide convenience for diabetes patients...marketing rights to canagliflozin except for parts of Asia

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

Preclinical treatment goals for the TNBC and IBC indications are two-pronged: as a tumor reduction agent in combination with other approved drugs in preoperative settings and as a drug to treat and control or eliminate cancer metastasis in TNBC and IBC patients...Distribution of Prothena ordinary shares in the demerger is conditioned upon, among other conditions to the demerger, a registration statement filed with the SEC, having been declared effective by the SEC and the affirmative vote of the

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. The PDUFA data will be July 21, 2013. AstraZeneca plc, of London, said it agreed with the FDA on label changes for Faslodex (fulvestrant) injection, updating the label with results and a Kaplan-Meier plot of the final overall survival (OS

Its expenses related to the terminations will be $280,000 in the fourth quarter...Spherix Consulting will continue to be headed by Claire Kruger, who resigned as CEO and director, as a division of ChromaDex, and Robert A. Lodder has taken over as principal executive officer of Spherix Inc., and a number of board members have resigned...Synthetic Biologics said it intends to develop an oral beta-lactamase enzyme product candidate, SYN-004, which is designed to be co-administered with certain beta

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. Financial terms were not disclosed.

The news came late Thursday, shortly after the company disclosed FDA approval of Cometriq in MTC...The company, which expects to launch the drug in late January, priced the drug at $9,900 for a 28-day supply. (See BioWorld Today, Nov. 30, 2012...Isotechnika recently received FDA clearance to begin a Phase III program testing voclosporin in kidney transplant patients

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