Alfacell expects to provide an update on the planned completion of the rolling NDA within 48 hours of the conclusion of the pre-NDA meeting...The FDA also is reviewing several other Byetta prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format...The FDA is expected to notify ImClone on the application's acceptance in February

Antigenics Inc., of New York, said it submitted a marketing authorization application under the conditional authorization provision to the European Medicines Agency for Oncophage in earlier-stage, localized renal-cell carcinoma...to raise capital and evaluate strategic alternatives designed to enhance shareholder value, including a potential merger, sale, licensing or partnership transactions

Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said it intends to incorporate additional data into the European marketing authorization application for Glybera for lipoprotein lipase deficiency...Innate Pharma, of Marseille, France, has acquired the worldwide exclusive development and commercial rights to IPH 2101, a fully human anti-KIR monoclonal antibody, from Novo Nordisk A/S, of Bagsvaerd, Denmark, in exchange for €2.5 million (US$3.37 million) and rights to IPH 2301, the

There currently are no other recombinant forms of antithrombin available to treat that patient population...Innate Pharma, of Marseille, France, has acquired the worldwide exclusive development and commercial rights to IPH 2101, a fully human anti-KIR monoclonal antibody, from Novo Nordisk A/S, of Bagsvaerd, Denmark, in exchange for €2.5 million (US$3.37 million) and rights to IPH 2301, the first compound from a prior collaboration between the companies, which is being developed in inflammation

Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said it intends to incorporate additional data into the European marketing authorization application for Glybera for lipoprotein lipase deficiency...The funding is to use several Ibis assays to characterize samples provided by the government and to support development of other assays...The project ranges from human forensics, to detection and identification of influenza viruses and other pathogens

BioAlliance Pharma SA, of Paris, appointed Pierre Morgon to the new post of managing director, with responsibility for marketing operations in all countries...At the same time, BioAlliance Pharma reported a 10 percent drop in its net loss to €7.9 million (US$11.5 million) in the first half of this year, when its revenues soared to €4.9 million from just €312,000 in the first six months of 2007

The FDA's action was expected, but analyst Michael Aberman, of Credit Suisse LLC, said in a research note that the language is "surprising" since "we believe it is premature to make any judgment regarding the true risk of PML with Tysabri monotherapy...In other news, Proteome said it will stop active efforts to develop and commercialize a therapeutic compound portfolio acquired through its 2005 merger with Eukarion Inc., of Bedford, Mass., in favor of concentrating on its biomarker discovery and

GPC Biotech AG, of Martinsried, Germany, announced that its partner for satraplatin in Europe, Boulder, Colo.-based Pharmion Corp., plans to withdraw the marketing authorization application for satraplatin plus prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed...In other news, Rosetta said the first molecular test based on its microRNA technology has been approved for clinical use by the New York State Department of Health Clinical

ActivBiotics Pharma LLC, of Atlanta, a new company, said it has acquired assets and rights related to Rifalazil from the defunct ActivBiotics Inc., of Lexington, Mass...EPIX Pharmaceuticals Inc., of Lexington, Mass., said Michael Kauffman has resigned as director and CEO to pursue other opportunities...GPC Biotech AG, of Martinsried, Germany, announced that its partner for satraplatin in Europe, Boulder, Colo.-based Pharmion Corp., plans to withdraw the marketing authorization application for

expects to begin a Phase IIb trial in 2009 with £8 million (US$16 million) from The Wellcome Trust and the Aeras Global TB Vaccine Foundation...Nexmed plans to work with the agency to address the issues and resubmit the NDA

Archimedes Pharma Ltd., of Reading, UK, said it received European Union funding of €2.77 million (US$4.39 million) over three years to develop a vaccine against the avian influenza virus...The goal is to develop a nasally delivered vaccine against highly pathogenic strains of the influenza virus (HF591 and other H5 and N7 subtypes) using the company's proprietary nasal delivery platform, ChiSys and to demonstrate clinical proof of principle

If successful, it could expand to include other types of manufacturing facilities...KG has sold all shares of Rentschler Pharma GmbH to Riemser Arzneimittel AG, of Riems, Germany...Wyeth, of Madison, N.J., said the European Commission has approved marketing authorization for a new 50mg Enbrel (etanercept) once weekly dosage regimen as an alternative to the currently approved 25mg Enbrel twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis

Sciele Pharma Inc., of Atlanta, said it has signed an exclusive agreement with Addrenex Pharmaceuticals Inc., of Durham, N.C., to develop and market ADX415, a centrally-acting alpha adrenergic receptor agonist, specific to Alpha-2 receptors, for the treatment of hypertension and other potential indications

Basilea plans to co-promote the drug in Canada with its partner Janssen-Ortho Inc., of Toronto...DuoCort Pharma AB, of Helsingborg, Sweden, said the FDA has granted an orphan drug designation for the company's DuoCort hydrocortisone dual-release oral tablet in development for the treatment of adrenal insufficiency - the inability of the body to produce sufficient amounts of the essential hormone cortisol

DuoCort Pharma AB, of Helsingborg, Sweden, said the FDA has granted an orphan drug designation for the company's DuoCort hydrocortisone dual-release oral tablet in development for the treatment of adrenal insufficiency - the inability of the body to produce sufficient amounts of the essential hormone cortisol...ProStrakan plans to launch Abstral in Sweden in the third quarter, and across Europe by the end of the year

To date, preclinical studies support the compound's development in rheumatoid arthritis and several other indications, including multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease...Replidyne Inc., of Louisville, Colo., said it has decided to terminate its license agreement with Tokyo-based Asubio Pharma Co

The three-year agreement calls for the German organization to implement the Intercept platelet system upon its receipt of marketing authorization from the Paul Ehrlich Institute for Intercept-treated platelets, the successful outcome of a hemovigilence study it will conduct and acceptance by its customers...to pursue contract production, process development and manufacturing services

DioGenix plans to refine those gene sets and to further confirm their disease association before developing an assay and is seeking strategic alternatives to fund product development efforts...filed a marketing authorization application in Switzerland for Amitiza (lubiprostone) for chronic idiopathic constipation in adults...Targanta Therapeutics Corp., of Cambridge, Mass., submitted a marketing authorization application (MAA) to the European Medicines Agency for its lead candidate oritavancin, a semi

CVBT will pay a royalty to PDLP of 10 percent of revenues or other moneys received from the commercialization of the drug candidate up to a maximum of twenty times the funded amount of the development agreement in exchange for the intellectual property created...Oncolytics Biotech Inc., of Calgary, Alberta transferred cGMP production for Reolysin at the 40-liter batch size to SAFC Pharma, a division of Sigma-Aldrich Corp., of St. Louis