DUBLIN – Shares in DBV Technologies Inc. plunged on news that its Viaskin peanut allergy therapy failed to reach statistical significance in a pivotal phase III trial in children. The most immediate beneficiary was Aimmune Therapeutics Inc., of Brisbane, Calif., whose stock rose by more than one-third Monday, with investor attention switching to its AR-101 oral desensitization therapy, which is currently undergoing a phase III trial in children and adults. Read More

Nearly 10 years after Trang Doan Nguyen pleaded guilty in a U.S. district court in Missouri to a misdemeanor of introducing misbranded drugs into interstate commerce, the FDA issued a final order debarring her, on the basis of that 2008 plea, for five years from providing services in any capacity to a person that has an approved or pending drug application. Read More

Gemphire Therapeutics Inc., of Livonia, Mich., reported preclinical data testing gemcabene in the STAM mouse model of non-alcoholic steatohepatitis (NASH). The highest dose of gemcabene produced a significant histological reduction in the nonalcoholic fatty liver disease activity score. Read More

Antares Pharma Inc., of Ewing, N.J., said the FDA issued a complete response letter (CRL) on the new drug application for the company's Xyosted (testosterone enanthate) injection. The CRL lists two possible problems with the drug's clinical data from studies QST-13-003 and QST-15-005. Read More

Sweden's Wilson Therapeutics AB said that the first patient in a single pivotal trial of its copper-protein-binding agent for the rare copper-excess condition, Wilson disease, is expected to be enrolled in early 2018. Data from the study is anticipated to follow in the second half of 2019. Read More

With its lead asset in the clinic to assess its effectiveness to prevent Clostridium difficile (C. diff) infection (CDI), Finch Therapeutics Inc. looked two miles down the road and took a calculated step to expand its presence in the microbiome field, orchestrating a merger with neighboring Crestovo LLC, whose phase II CDI asset, CP-101, was deemed superior. Read More

CLEVELAND – If the health care industry were a baseball game, it would currently be in the third inning, said Cleveland Clinic President and CEO Delos "Toby" Cosgrove, who told attendees of the 15th Medical Innovation Summit kicked off Monday he is "always stunned by the data [and by] how fast knowledge is accumulating." Read More

PERTH, Australia – After a few tumultuous years for Melbourne-based Phosphagenics Ltd., the company is recreating itself with a capital raising in the works and a new spate of global deals. CEO Ross Murdoch told BioWorld that he joined Phosphagenics in 2015 to help rebuild the firm's reputation after former CEO Esra Ogru swindled millions from the company. Read More

HONG KONG – China has approved a domestically developed vaccine for the deadly Ebola virus and is now the third country in the world, after the U.S. and Russia, with an approved vaccine. The CFDA-approved vaccine was co-developed by the military-backed Bioengineering Institute of the Chinese Academy of Military Medical Sciences and private drugmaker Cansino Biologics Inc., of Tianjin. Read More

LONDON – The EMA has pledged better support for the development of advanced tissue medicinal products (ATMPs) based on cells, genes or tissues, in response to long-running and repeated complaints by industry that the regulation is overcomplex and in some cases, inappropriate. Read More

Spero Therapeutics Inc., of Cambridge, Mass., has set terms for its IPO and will sell 5 million shares of common stock priced between $14 and $16 per share. Its lead candidate SPR-994 is an oral formulation of tebipenem pivoxil designed as the first broad-spectrum oral carbapenem-class antibiotic to treat adults with multidrug-resistant (MDR) gram-negative infections, with the goal of preventing hospitalizations for serious infections and enabling earlier treatment of patients following hospitalization. The initial target is complicated urinary tract infections. The company has applied to list its common stock on the Nasdaq Global Market under the symbol SPRO. (See BioWorld, Oct.10, 2017.) Read More

Enanta Pharmaceuticals Inc., of Watertown, Mass., reported results from a phase Ia/b trial testing its FXR agonist EDP-305 in healthy volunteers and patients with presumed non-alcoholic fatty liver disease. The pharmacokinetic data supports once daily oral dosing of EDP-305. Read More