Given the power of a name and the fact that more biosimilars are moving through the global pipeline, the World Health Organization (WHO) is facing increased pressure this week to come up with a new international nonproprietary naming (INN) scheme for the follow-on drugs. Read More
HONG KONG – Defying all expectations of an early announcement, biosimilar developers in China are unlikely to see any kind of regulatory framework in the near future. Read More
“Best case scenario” was the phrase flying around after last week’s approval of Actelion Ltd.’s Opsumit (macitentan), the next-generation dual endothelin receptor antagonist (ERA) for pulmonary arterial hypertension. Read More
LONDON – Anergis SA released new immunological data from the Phase IIb study of its lead product Allert, proving the synthetic allergy vaccine acts in the same way as traditional desensitizing allergy treatments and providing a comfort factor for potential pharma partners as licensing discussions progress. Read More
Tetralogic Pharmaceuticals Inc. added its name to the growing list of biotechs aiming to take advantage of the booming initial public offering (IPO) market, filing for a potential $103.5 million IPO to fund work on its cancer drug pipeline. Read More
Scientists have reported evidence that the brain’s equivalent of the lymphatic system, called the “glymph” system, undergoes massive structural changes with the sleep-wake cycle, and that those changes enable it to dispose of toxic waste proteins. Read More
• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., signed a research agreement with the U.S. Department of Defense, Defense Threat Reduction Agency for design of new classes of systemic antibiotics. Read More
• MEI Pharma Inc., of San Diego, announced results from a Phase I single-agent study of its investigational mitochondrial inhibitor drug candidate, ME-344, in patients with refractory solid tumors. Read More
• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said the safety, tolerability and immunogenicity of its therapeutic vaccine for hepatitis C (INO-8000/VGX-6150) will be studied in an 18-patient Phase I trial in chronically hepatitis C virus-infected patients. Read More
• Opko Health Inc., of Miami, reported that its Barcelona-based subsidiary, Pharmadiet S.L.U., received final marketing approval from Spain’s health authority (Agencia Española de Medicamentos y Productos Sanitarios) for commercialization of its oral and injectable formulations of citicoline. Read More
• The Supreme Court rejected an appeal Monday from Novo Nordisk A/S, leaving the door open for U.S. plaintiffs to sue both an American drugmaker and its foreign parent corporation to increase the pressure to settle. Read More
