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

The product is designed to treat chronic diabetic macular edema considered insufficiently responsive to available therapies...Ltd., of Tokyo, to develop bispecific antibodies based on Genmab's DuoBody platform

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

In other news, Bayer said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete...In other news, Viralytics is offering shareholders up to $15,000 worth of shares at 30 cents each in a new underwritten share purchase plan to fund the company's intravenous cancer trial and the continued clinical research and development of Cavatak, its lead oncolytic virus candidate

To date, none of the gene targets associated with the obese phenotype has provided a viable drug therapy...The technology is designed to identify all antibodies of a specific target across large populations of lymphocytes...Sernova Corp., of London, Ontario, published a method to evaluate insulin-producing donor islets prior to transplant as a predictor of which transplants are most likely to reverse diabetes in Cell Transplantation

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

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 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.