TOKYO – Japan's Ministry of Health, Labor and Welfare (MHLW) approved six new drugs, including one biosimilar, underscoring the country's drive to speed up drug approvals. And, in some instances, the approvals were done faster than in the U.S. Read More
DUBLIN – UK investors were unmoved Tuesday by Abbvie Inc's improved cash-and-shares indicative offer for Shire plc, which values the specialty pharma firm at £30.1 billion (US$51.3 billion), or at £51.15 per share. Read More
SHANGHAI – Yabao Pharmaceutical Co. Inc., of Beijing, has entered a partnership with Eli Lilly and Co. to co-develop Lilly's leading glucokinase activator (GKA), LY2608204, for China's diabetics. Read More
Anacor Pharmaceuticals Inc. on Tuesday won earlier-than-expected FDA approval for its first drug, Kerydin (tavaborole), a topical antifungal for the treatment of the common toenail and nail bed infection onychomycosis. Read More
A pair of identical phase III trials hit their endpoint targets using sustained-exposure ciprofloxacin (branded Auripro, formerly OTO-201) in pediatric patients with bilateral middle ear effusion – fluid buildup – requiring tympanostomy tube placement, and Otonomy Inc. remains on track for a new drug application (NDA) filing in the first quarter of next year. Read More
SHANGHAI – As part of health care reforms, China has been piloting "zero markups" for drugs sold at hospitals for several years in a bid to reduce and rationalize the cost of health care. Read More
Sciclone Pharmaceutical Inc. is headquartered in the U.S. but it focuses its efforts in China, a market that is fast-growing and attractive, though also has its challenges. Read More
The NIH is taking its Alzheimer's research to the next level, awarding about $24 million in grants to scientists at eight academic medical centers who will analyze how genome sequences may contribute to increased risk or protect against the disease. Read More
Bluebird Bio Inc., of Cambridge, Mass., said in a prospectus supplement filed with the SEC that it plans to offer $100 million in common shares through an underwritten public offering. The company did not disclose pricing. Read More
Insys Therapeutics Inc., of Phoenix, disclosed completion of a human abuse study for dronabinol oral solution development for the treatment of chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS. Read More
Synergy Pharmaceuticals Inc., of New York, said it completed an end-of-phase II meeting with the FDA on lead drug plecanatide, a uroguanylin analogue, for the treatment of irritable bowel syndrome with constipation (IBS-C) and reached agreement with the agency for the pivotal phase III IBS-C program set to start in the fourth quarter. Read More
Purdue Pharma LP, of Stamford, Conn., said the FDA granted priority review to the company's once-daily, single-entity hydrocodone bitartrate tablet for use as a pain treatment. Read More
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said results from a phase II study published in Blood showed that patients with previously untreated acute myeloid leukemia (AML), ages 65 and older and ineligible for intensive remission induction therapy, lived longer when treated with volasertib combined with low-dose cytarabine (LDAC) vs. LDAC alone. Read More
