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 product is designed to treat chronic diabetic macular edema considered insufficiently responsive to available therapies...Apexigen Inc., of Burlingame, Calif., signed a manufacturing supply agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, under which the big pharma firm will provide cell line development with the high expression BI-HEX system, full process and method development, scale-up and clinical Phase I supply for APX005, a humanized monoclonal antibody designed to target

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

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

Akela Pharma Inc., of Vancouver, British Columbia, said it applied for voluntary delisting from the Toronto Stock Exchange, citing an inability to maintain the continuous listing requirements...Its expenses related to the terminations will be $280,000 in the fourth quarter

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

The news came late Thursday, shortly after the company disclosed FDA approval of Cometriq in MTC...Isotechnika Pharma Inc., of Edmonton, Alberta, said a partial award has been issued in the company's ICC arbitration regarding its right to terminate the development, distribution and license agreement with Iljin Life Sciences Co

Details Date Advaxis Inc. (Princeton, N.J.) Private placement N/A $10 Advaxis secured $10M in equity financing from Magna Group LLC 11/1/12 Amarantus BioSciences Inc. (Sunnyvale, Calif.) Private placement N/A $1.1 Amarantus secured $1.1M in funding through two separate transactions, by issuing a convertible promissory note to an undisclosed investor in the principal amount of $600,000 and, with an institutional fund, settled more than $500,000 in accounts payable 11/15/12 Ambit Biosciences Inc

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...Under the terms, Nordic Pharma will commercialize the product in those areas, with Medigene receiving milestone payments and double-digit royalties on sales, as well as certain payments

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...Pfizer Inc., of New York, said it completed its acquisition of Cupertino, Calif.-based NextWave Pharmaceuticals Inc., a privately held specialty pharma firm developing products for attention deficit hyperactivity disorder

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

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 contract, issued under the Russian Federation's "Pharma 2020" development initiative, provides matching funding over a period of about three years, which will be used to support preclinical and clinical studies...Early this year, Theravance's partner for Vibativ, Astellas Pharma Inc., of Tokyo, handed back full rights to the program. (See BioWorld Today, Dec. 1, 2009...The company plans to disclose a new ticker symbol in January

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.

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

In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013...Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was