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

Those and other data are set to be presented at the American Society for Hematology meeting in Atlanta next month...Should the trial hit the predefined overall survival endpoint, the company said it expects those data to support marketing applications for AlloStim in the U.S., European Union and other jurisdictions

Forest Laboratories Inc., of New York, and Gedeon Richter plc, of Budapest, Hungary, said Forest submitted a new drug application for cariprazine, a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, for use in schizophrenia and bipolar mania...Upon the close of the transaction, Pfizer holds exclusive North American commercialization rights to Quillivant XR (methylphenidate hydrochloride) for extended-release oral suspension, a once-daily liquid medication for ADHD

Ildong gained exclusive rights to commercialize temanogrel in South Korea for myocardial infarction, acute coronary syndrome, stroke, peripheral artery disease and other cardiovascular diseases...Arena retained ownership of temanogrel outside South Korea and the rights to use data generated by Ildong to develop and commercialize temanogrel outside South Korea by Arena or other licensees...Arena also is eligible to receive a royalty on net sales of temanogrel in South Korea, while Ildong is eligible to

Spectrum has continued to increase the number of qualified third-party manufacturing sites approved for Fusilev production since the product was approved in 2011 for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of metastatic colorectal cancer...The company is seeking to expand the approval of Vibativ, currently marketed for bacterial skin infections, for patients with nosocomial pneumonia, including ventilator-associated pneumonia, caused by susceptible isolates

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

Activiomics will apply its TIQUAS phosphoproteomics platform to elucidate signaling mechanisms of lead compounds in relevant cell-based systems...The TGA approval will enable health professionals to prescribe Aubagio 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September. (See BioWorld Today, Sept. 14, 2012

The good news is that our disaster plan worked," added Lewis, who had reviewed the plan when he joined Insmed in September and conducted daily meetings with staff during the week prior to the hurricane's arrival...OHRP indicated participants who are unable to receive research interventions at their usual clinical trial site may temporarily receive the stated care at other facilities, which are not required to secure IRB review and approval

The company said it would have needed to raise considerable additional capital in order to return to compliance with the New York Stock Exchange listing requirements...The moves follow an increase to authorized common stock of the company in October 2012 and changes to the terms of the company's Series A preferred shares the previous August

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.

The company has programs to develop inhibitors for DOT1L for MLL-rearranged leukemia and EZH2 for mutant-bearing non-Hodgkin lymphoma...Senesco, however, failed to meet continued listing requirements, and the NYSE said it will grant no more extensions...NeuroVive provided Sihuan an exclusive license to develop, market and sell the compounds in China, as well as the intellectual property rights and know-how to advance the compounds through clinical trials

The goal is to develop therapies to treat a number of rare pediatric diseases with high unmet medical need using Boston Children's research expertise and Shire's development and commercialization capabilities...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

Alexza expects to receive the CHMP Day 210 Opinion in December...HemaXellerate is designed to deliver a population of endothelial cells to restore blood production in patients with hematological conditions

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

Funds will be used to compare Tregitopes to IVIG...The merger remains subject to other conditions, including approval from Medicis' stockholders, who are expected to meet Dec. 7

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