New-generation therapies for hepatitis C virus (HCV) have been wildly successful – so much so that they've caused a conundrum at market leader Gilead Sciences Inc., whose drugs Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) have produced high cure rates in patients with chronic HCV, leading to slumping sales. (See BioWorld Today, May 3, 2017.) Read More

Mice have been criticized before as being inadequate models of inflammation. (See BioWorld Today, Feb. 12, 2013.) Now, researchers from the British London School of Hygiene and Tropical Medicine and University of Bristol have extended that criticism to the adaptive immune systems of laboratory mice. The researchers compared the immune systems of pathogen-free laboratory mice of the C57BL/6 strain with mice trapped in the wild. Read More

Genfit SA, of Lille, France, said the first patient has been enrolled in a phase IIa trial evaluating elafibranor in primary biliary cholangitis (PBC). The three-arm (80 mg, 120 mg and placebo) study will evaluate the efficacy and safety of the compound in adult patients with PBC and inadequate response to ursodeoxycholic acid. It will enroll 45 patients (15 patients per arm) who will receive 12 weeks of treatment. The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase, based on relative change from baseline to end of treatment compared to placebo. Read More

Amag Pharmaceuticals Inc., of Waltham, Mass., announced the pricing of an upsized underwritten public offering of $300 million worth of convertible senior notes, due 2022. The original offering sought to raise $250 million. J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as book-running managers. Amag has granted them the option to purchase up to an additional $45 million principal amount of notes solely to cover overallotments. The offering is expected to close on May 10. Read More

Otonomy Inc., of San Diego, said net sales of Otiprio (ciprofloxacin) totaled $400,000 for the first quarter. In March, the company announced a number of changes to its commercial organization to increase the focus on Otiprio utilization and improve sales performance, including the hiring of a new vice president of sales. The company reported a first-quarter net loss of $27,078, about the same as its first quarter 2016 loss. Read More

Altimmune Inc., of Gaithersburg, Md., completed its merger with Pharmathene Inc., of Annapolis, Md. The combined company was renamed Altimmune and will trade on Nasdaq under the ticker ALT. Immediately prior to the merger, Altimmune executed a 1-for-10 reverse stock split of outstanding shares of its common stock. Read More

DUBLIN – Inflaming the tumor microenvironment has become the focus of a wide-ranging effort on the part of immuno-oncology researchers vying to boost the response rates of cancer immunotherapies. The approaches vary widely, from combinations of immune checkpoint inhibitors to single checkpoint inhibitors combined with any number of agents, including traditional chemotherapy, radiotherapy, oncolytic viruses, targeted cancer drugs, cancer vaccines and other immunostimulatory treatments. The overriding aim is to turn off tumor-mediated immune suppression and to promote T-cell infiltration of tumors and recognition of cancer cells. Read More

PERTH, Australia – Although CEOs of life sciences companies in Australia said that 2016 was their strongest year yet, that optimism was dampened by uncertainty surrounding government policy on R&D tax incentives, according to AusBiotech's annual CEO survey. Read More

LONDON – Two new reports from the European Commission (EC) and EMA show that 10 years on from the first approval biosimilars are having a major impact on price and patient access and there is no evidence of any differences in safety and efficacy compared to reference products. Read More

Seattle Genetics Inc. (Seagen) pulled the final thread out of a tie-up that's been unraveling for weeks by consenting to terminate the license agreement it forged in February with Immunomedics Inc. for the late-stage development, manufacturing and commercialization of IMMU-132 (sacituzumab govitecan) in multiple indications. The potential $2 billion deal called for $250 million up front and an equity investment of up to $57 million, or up to a 9.9 percent stake in Immunomedics, putting Bothell, Wash.-based Seagen in the driver's seat of the antibody-drug conjugate (ADC), which is set to begin a phase III trial in metastatic triple-negative breast cancer (mTNBC). Read More