Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution. The drug has orphan status for use in improving neurological outcome in adults with subarachnoid hemorrhage. Prior to the approval of Nymalize, nimodipine was available only in gel capsule form. Arbor said it will launch the drug in the next few months. Cempra Inc., of Chapel Hill, N.C., signed an exclusive license and development agreement for oral solithromycin

Pearl Therapeutics Inc. launched its much-anticipated Phase III (PINNACLE) trial of PT003, a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered by pressurized hydrofluoroalkane, in chronic obstructive pulmonary disease (COPD). The Redwood City, Calif.-based company raised $65 million in a Series D financing in November to support the trial. (See BioWorld Today, Nov. 14, 2012.) The product is a combination of a long-acting muscarinic antagonist (LAMA), glycopyrrolate

AbbVie Inc.'s $70 million up front buys an option to acquire Alvine Pharmaceuticals Inc.'s drug candidate for celiac disease or the company itself, after Phase IIb trials are finished with ALV003, a two-enzyme combo that degrades gluten. The 500-patient Phase IIb study with ALV003, which is composed of a cysteine protease and a prolyl endopeptidase, should be finished late next year or early in 2015, said James Watson, chief business officer of San Carlos, Calif.-based Alvine. "It's starting

PharmaMar SA, of Madrid, Spain, a subsidiary of Zeltia, said it completed a Phase Ib trial testing PM01183 in combination with doxorubicin, with the combination displaying antitumor activity in all types of cancer included in the study. Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumors and synovial sarcoma. The company is planning a potential pivotal trial in small-cell lung cancer

Cosmo Pharmaceuticals SpA landed a hefty chunk of upside, that all-too-elusive commodity, by grossing $89.2 million from a sale of Santarus Inc. stock. The transaction will enable the already-profitable company to begin paying dividends to its shareholders. The Lainate, Italy-based drug delivery specialist disposed of 4.25 million shares, priced at $18.25 per share, Friday. On Monday, Jefferies LLC, which underwrote the offering, exercised its option to purchase an additional 637,500 Santarus

Astellas Pharma Inc. jumped on the bandwagon of big pharma restructurings, disclosing plans to close U.S. units OSI Pharmaceuticals LLC and Perseid Therapeutics LLC this year and to downsize Astellas Research Institute of America LLC to focus on central nervous system therapies. The company also plans to terminate its in-house fermentation research and, by fiscal 2015, to fold the operations of its Kashima facility in Osaka into other sites, including its Tsukuba (Japan) Research Center. Last

The ErbB family of receptor tyrosine kinases is well known to drug developers, though often under one of its aliases. ErbB1, better known as epidermal growth factor receptor, or EGFR, is the target of drugs such as Tarceva (erlotinib, Roche AG and Astellas Pharma Inc.), Iressa (gefitinib, AstraZeneca plc.), Vectibix (panitumumab, Amgen Inc.) and Erbitux (cetuximab, Eli Lilly and Co.) Roche drugs Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine) target ErbB2

A lack of standards from the Office of the U.S. Global Aids Coordinator (OGAC) is hampering the assessment of the President's Emergency Plan for AIDS Relief (PEPFAR) as partner-countries assume more responsibility for AIDS treatment programs within their borders, according to a report from the Government Accountability Office (GAO). Fully functioning monitoring and evaluation (M&E) systems are critical for tracking results and ensuring the effectiveness of the treatment programs, the GAO said

Omeros Corp., of Seattle, said it closed the registered direct offering of 3.9 million shares of common stock priced at $4.14 per share, raising net proceeds of about $16.1 million. Funds will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as funding planned clinical trials for its OMS103HP, PDE10, MASP-2 and PDE7 programs. Proceeds also may be used to fund

DUBLIN, Ireland – Elan Corp. plc is putting down a $1 billion bet that the respiratory franchise shared by Theravance Inc. and GlaxoSmithKline plc will pay generous dividends over the next decade. Elan is acquiring a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with London-based GSK. One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily

BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety monitoring board (DSMB) again recommended continuing the ReLive Phase III trial without modification. On Nov. 19, 2012, the DSMB unanimously recommended continuing the trial without modification. ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag (doxorubicin Transdrug) on survival in 400 patients with hepatocellular carcinoma after

Relypsa Inc., which last summer closed an $80 million Series C to fund its pivotal Phase III program of nonabsorbed oral potassium binder patiromer (RLY5016), has fully enrolled the two-part trial, which is evaluating efficacy and safety in treating hyperkalemia in patients with chronic kidney disease (CKD). The study is being conducted under a special protocol assessment (SPA) with the FDA, with top-line data expected to report in the fall. (See BioWorld Today, Aug. 16, 2012.) Launched in

LONDON – Shares in Erytech Pharma SA began trading in Paris last week following an initial public offering (IPO) that exceeded the €15 million (US$19.5 million) target, raising €16.7 million. The Lyon, France-based company added a further €11 million, mostly through the conversion of bonds, providing sufficient funding to take the lead program Graspa through to approval in Europe and to start a U.S. Phase Ib trial of the product in the treatment of acute lymphoblastic leukemia (ALL). "I'm very

A U.S. appellate court blocked Genentech Inc.'s end run around foreign arbitration that could give Sanofi SA a share of the royalties on blockbuster biologic Rituxan. In a precedent-setting decision Friday, the U.S. Court of Appeals for the Federal Circuit upheld a district court's decision to deny Genentech's request for an injunction on foreign arbitration over its terminated licensing contract for DNA enhancers allegedly used in the making of the biologic. Genentech, part of the Basel

Actavis Inc., of Parsippany, N.J., reported the FDA has accepted for filing its new drug application for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon

Dyax Corp. is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE). Burlington, Mass.-based Dyax already is well established in the HAE space, having gained approval of Kalbitor (ecallantide) for acute HAE attacks in late 2009. The drug, which Dyax markets on its own in the U.S., pulled in

Aastrom Biosciences Inc., of Ann Arbor, Mich., reported in an 8-K filing with the SEC that it was notified by Nasdaq that the bid price for its common stock closed below the minimum $1 per share requirement for 30 consecutive business days. Nasdaq provided the company 180 calendar days, or until Nov. 5, to regain compliance with the minimum bid price rule by closing at or above $1 per share for a minimum of 10 consecutive business days prior to that date. The company's shares tumbled in March

Biotie Therapies Corp., of Turku, Finland, began a Phase II study evaluating nepicastat (SYN117) in cocaine dependence. The randomized, double-blind, placebo-controlled 11-week trial is expected to enroll about 180 treatment-seeking cocaine-dependent subjects at approximately 12 U.S. clinics and take approximately two years to complete. The National Institute on Drug Abuse at the National Institutes of Health is funding the study under a Collaborative Research and Development Agreement signed