LONDON – Amgen Inc.'s cardiovascular franchise is cleared for takeoff with Repatha winning the EMA's nod, both as the first of a new class of PCSK9 inhibitors and as the first monoclonal antibody for a cardiovascular indication. Read More
With primary endpoint-missing phase IIb data in hand, Otonomy Inc. CEO David Weber told BioWorld Today that he is "more confident today" that OTO-104 for Meniere's disease is a viable product, and the company will be meeting with the FDA to talk about the planned phase III program. Read More
A consortium of some of China's biggest health care players is snapping up trans-Pacific protein therapeutics developer Ambrx Inc. for an undisclosed amount in a bid to accelerate the introduction of innovative, and presumably more profitable, therapies to the Chinese market. Read More
Researchers at Boston Children's Hospital have used a novel type of screening to identify a compound that caused massive weight loss in mice with diet-induced obesity, causing them to lose 45 percent of their body weight. Read More
HONG KONG – After eyeing biopharmaceuticals as a key area for breakthrough developments, China's State Council has released a roadmap for the manufacturing sector. Read More
Cel-Sci Corp., of Vienna, Va., priced a best-efforts offering of common stock and warrants at a combined price of 79 cents per unit for gross proceeds of up to $16 million. Read More
Merus Labs International Inc., of Toronto, said one of its wholly owned subsidiaries signed a deal to acquire the rights to manufacture, market and sell two established specialty pharmaceutical products in certain European and other markets. Read More
Cardiorentis AG, of Zug, Switzerland, completed enrollment in True-AHF, its pivotal phase III trial for the treatment of acute heart failure (AHF), an event-driven trial that enrolled 2,157 patients with AHF. Read More
Researchers at the University of California at San Francisco have gained new insights into why childhood vaccinations appear to protect not only against the specific infections they were developed against, but also against the development of acute lymphoblastic leukemia, a pediatric B-cell cancer whose incidence has fallen drastically since the advent of routine vaccinations. Read More
