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

Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Lilly said it will stop development of enzastaurin, a serine/threonine kinase inhibitor of the PKC beta and AKT pathways, and

Few of the pundits and tea-leaf readers handicapping the chances for approval of once-daily inhaled Breo (fluticasone furoate /vilanterol) in the wake of last month's FDA advisory panel were surprised by the agency's go-ahead for the chronic obstructive pulmonary disease (COPD) treatment from GlaxoSmithKline plc and Theravance Inc. Breo Ellipta, as the product is branded, will launch in the third quarter of this year. Theravance CEO Rick Winningham said his firm owes GSK a $30 million

The typical goal of stem cell therapies is to get the mature cells they produce to take up permanent residence in patients. But there is one therapeutic area where the opposite is true: Scientists are injecting stem cells that function as temporary drug delivery vehicles for brain tumors. "Over time, the cells tend to die off," Karen Aboody told BioWorld Today. But for this particular application, that lack of staying power is a strength, not a weakness. "We really only need our cells to be

Practically overnight, Affymax Inc. went from being lauded as a biotech success story and Wall Street darling to become one of the sector's biggest disappointments, and now, according to the latest 10-Q filing, the Palo Alto, Calif.-based firm might be nearing its end. Despite drastic cuts to its staff – 75 percent of employees were let go in March, and dates of separation are in the works for the remaining 25 percent, including the CEO and chief financial officer by June 15 – and restructuring

Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported product revenue totaling $202.6 million for the first quarter, up 18 percent over the same period in 2012. Sales of antibiotic Xifaxan (rifaximin) reached $153 million. Non-GAAP net income was $40.1 million, or 63 cents per share, falling short of consensus estimates of 68 cents per share. Salix ended the first quarter with about $960.3 million on its balance sheet. Despite the earnings miss, the firm's shares (NASDAQ:SLXP) gained $2.99

Actavis Inc., of Parsippany, N.J., on Friday confirmed that it entered early stage discussions with Warner Chilcott plc, of Dublin, Ireland, regarding a potential combination of the two companies. The big pharma said no agreement has been reached and it does not intend to issue further comments. Several weeks ago, there were reports that Valeant Pharmaceuticals International Inc., of Montreal, was in talks to acquire Actavis. On Friday, Shibani Malhotra, an analyst with RBC Capital Markets LLC