An investigative committee at the Japanese Riken Institute has said it found two instances of “inappropriate handling” of data in recent high-profile papers on a new way of generating cells with stem cell-like characteristics. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., appointed Jay A. Barth chief medical officer, and Bradley L. Campbell, previously chief business officer, has been named chief operating officer. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA approved Noxafil (posaconazole) injection (18 mg/ mL), a new formulation of Noxafil for intravenous use. Merck’s antifungal agent is also marketed as Noxafil (100 mg) delayed-release tablets and Noxafil (40 mg/mL) oral suspension. Read More
Achillion Pharmaceuticals Inc., of New Haven, Conn., said presentations at the Asian Pacific Association for the Study of the Liver in Brisbane, Australia, included updated phase II results evaluating a 150-mg loading dose following by 50 mg once daily of ACH-3102, a second-generation NS5A inhibitor, in combination with either once-daily 200 mg or 400 mg of sovaprevir and twice-daily ribavirin in hepatitis C virus (HCV) patients. Read More
Intrexon Corp., of San Carlos, Calif., said it acquired laboratory operations in Budapest, Hungary, from Codexis Inc., a developer of biocatalysts for the pharmaceutical and complex chemistry industries. Read More
Researchers may have discovered why a certain antibiotic class can be highly toxic, and a pathway toward making it less so, while looking for something different altogether. Read More
Despite the mandate in section 907 of the FDA Safety and Innovation Act of 2012 (FDASIA) that the FDA seek the inclusion of demographic “subgroups” in clinical trials, both the agency and drugmakers have struggled to improve participation rates among historically underrepresented populations, especially African Americans and Hispanics. Read More
SINGAPORE – Biosimilars are generating more interest among Asian developers, which are rapidly moving into a space that is likely to see skyrocketing sales before the end of the decade. Read More
Already trading weakly as a public entity thanks to its reverse merger in the fall of last year, Ignyta Inc. priced an initial public offering (IPO) of about 5.2 million shares at $9.15 each, for gross proceeds of about $48 million and a net haul of about $44.5 million. Read More
News of additional positive data from three phase III trials for Anoro Ellipta (umeclidinium/vilanterol), the first FDA-approved combo long-acting beta2-adrenergic agonist (LABA)/long-acting muscarinic antagonist (LAMA), generated little buzz for Theravance Inc., though it adds further ammunition as partner Glaxosmithkline plc fights to maintain its hold on the respiratory disease market in the face of generic threats to its top-selling Advair/Seretide franchise. Read More
