The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) split 12-11 on a vote that data presented from the safety study, EMPA-REG OUTCOME, provided substantial evidence that Jardiance (empagliflozin, Boehringer Ingelheim Pharmaceuticals GmbH/Eli Lilly and Co.) reduced cardiovascular mortality in the study population. The data were reviewed in relation to proposed label expansions for Jardiance and Synjardy (empagliflozin and metformin hydrochloride) tablets. Read More

Shire plc, of Dublin, reported top-line results showing that a four-week randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration, efficacy and safety study met it primary endpoints for both doses of SHP465 (12.5 mg and 37.5 mg), administered once daily, in patients with attention deficit hyperactivity disorder (ADHD). Read More

Nektar Therapeutics Inc., of San Francisco, appointed John Nicholson senior vice president and chief operating officer and Gil M. Labrucherie senior vice president and chief financial officer. Read More

Lipocine Inc., of Salt Lake City, said it received a complete response letter (CRL) from the FDA on the new drug application for LPCN 1021, its twice-daily oral hydroxyprogesterone caproate candidate designed for testosterone replacement therapy in adult males with hypogonadism. Read More

Sernova Corp., of London, Ontario, said it is increasing its non-brokered private placement to C$4.2 million (US$3.2 million), equal to 16.8 million units at C$0.25 each, to accommodate additional over-subscriptions. Read More

Months after rebranding itself, Biostage Inc. is asking the FDA for orphan drug designation for its Cellspan esophageal implants, designed as an alternative to esophagectomy. CEO Jim McGorry said the company, which also is developing products for the bronchus and trachea, plans to file an IND application by the end of the year. "Assuming approval on a normal time frame, we believe that by this time next year our Cellspan esophageal implant should be in a human clinical pilot study," he told BioWorld Today. Read More

SHANGHAI – Jiangsu Hengrui Medicine Co. Ltd. is one of China's most profitable non-state-run pharmaceutical firms focused on generics. With a market cap of $14.2 billion, last year Jiangsu Hengrui raked in revenues of $1.4 billion with a net profit of $327 million. But Chairman Piaoyang Sun saw the writing on the wall a few years back and has been preparing his company for an innovative future, one in which the U.S. plays a key role. Read More

Analysts had plenty of questions but Esperion Therapeutics Inc. offered few answers regarding the FDA's stalling on oral, once-daily bempedoic acid (ETC-1002) for lipid lowering, after the agency told company officials it's uncertain about an acceptable endpoint and how the treatment paradigm might transform. Read More

HONG KONG – China's economy may be slowing down, but multinationals are positioning themselves to leverage it as best they can while navigating a still-complex regulatory environment. The latest: Pfizer Inc. this week broke ground on a $350 million biotechnology facility in eastern Hangzhou. The Global Biotechnology Center will be Pfizer's first biotech center in Asia and its third globally. Read More

Cancer vaccines tailored to fit tumor-specific profiles are at the heart of a new strategic collaboration and licensing deal between Merck & Co. Inc. and Moderna Therapeutics Inc., a company on which Merck is upping its bet as early clinical data begins to roll in as part of an earlier deal between the two targeting infectious disease. Read More

Findings from the phase III NOVA trial of niraparib in women with recurrent ovarian cancer blasted shares of developer Tesaro Inc. to an historic high after the company reported the trial achieved its primary endpoint of statistically significant progression-free survival (PFS) compared to control across germline BRCA mutation (gBRCAmut) carriers and non-gBRCAmut carriers, including those with homologous recombination deficient (HRD) tumors. Read More

HONG KONG – Dendritic cell-based vaccine strategies that target cancer stem cells (CSCs) may be most effective when they are used in the adjuvant setting, according to findings of a new U.S./China collaborative preclinical study in mice reported in Cancer Research. Read More