Active Biotech AB, of Lund, Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said the EMA's Committee for Medicinal Products for Human Use (CHMP) confirmed its Jan. 23 opinion to recommend against approval of Nerventra (laquinimod) for the treatment of relapsing-remitting multiple sclerosis at this time. Both companies said they remain committed to the clinical development programs and on evaluating the CHMP feedback to determine potential next steps.

Aztherapies Inc., of Boston, said it received notice from the FDA that it may proceed with a phase III study of its lead program, ALZT-OP1, as submitted in its investigational new drug application. The combination therapy, designed to prevent and treat early Alzheimer's disease (AD), consists of two previously approved, undisclosed drugs that act on mechanisms relevant to the disease, using a different formulation and targeted delivery to boost blood and brain concentrations for improved action. The company said one drug inhibits beta-amyloid peptide polymerization and the second inhibits the neuro-inflammatory response in patients with amnestic mild cognitive impairment due to suspected AD. Aztherapies said both drugs have good safety and tolerability profiles and are being repurposed using technology licensed from Massachusetts General Hospital and advanced by the company to slow cognitive loss or prevent the onset of dementia due to AD. Aztherapies plans to request a special protocol assessment from FDA on the design and size of a trial to support a 505(b)(2) new drug application for ALZT-OP1 in early AD, with a projected phase III safety and efficacy study to begin in the fourth quarter.

Biogen Idec Inc., of Cambridge, Mass., said it received a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the marketing authorization of Plegridy (peginterferon beta-1a) to treat adults with relapsing-remitting multiple sclerosis. The company's biologics license application for Plegridy was based on data from the first year of the two-year, phase III ADVANCE study. (See BioWorld Today, Jan. 25, 2013.)

Genmab A/S, of Copenhagen, Denmark, and Glaxosmithkline plc, of London, said the EMA's Committee for Medicinal Products for Human Use issued a positive opinion recommending a variation to the terms of the marketing authorization for Arzerra (ofatumumab) for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. Arzerra, a CD20-targeting monoclonal antibody, is indicated for CLL patients refractory to fludarabine and alemtuzumab in more than 50 countries and gained FDA approval in April for use in combination with chlorambucil in previously untreated CLL patients for whom fludarabine-based therapy is considered inappropriate.

Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said company plans a 1-for-4 reverse split of the company's shares (NYSE MKT:INO) following shareholder and board approval. The company did not disclose the effective date of the reverse split.

Keryx Biopharmaceuticals Inc., of New York, said the FDA extended by three months the initial PDUFA date for its review of the new drug application (NDA) for Zerenex (ferric citrate), setting a new PDUFA date of Sept. 7. Keryx said the notification letter indicated the company's response to the FDA's request for additional chemistry, manufacturing and controls information included substantial revisions that the agency considered a major amendment to the NDA, so the PDUFA date was extended to provide time for a full review of the submission. The company said its commercial team is continuing to prepare for the potential launch of Zerenex late in the third quarter. (See BioWorld Today, Aug. 9, 2013.)

Polytherics Ltd., of London, announced the formation of a new company, Abzena Ltd., which will establish headquarters in Cambridge, UK, and aim to provide group identity across its two wholly owned subsidiaries, Polytherics and Antitope. The move follows Polytherics acquisition of Cambridge, UK-based Antitope Ltd. last year. (See BioWorld Today, July 31, 2013.)

Targos GmbH, of Kassel, Germany, and Wuxi Pharmatech Inc., of Shanghai, said they inked a biomarker collaboration in which Targos will provide know-how, services and quality standards to support Wuxi's bioanalytical work for pharmaceutical customers. The collaboration will focus on the validation and analysis of clinical tissue biomarkers in cancer. Financial terms were not disclosed.