Topic:

Regulatory

Latest Headlines

Latest Headlines

Japan's PAFSC puts off decision on new Xarelto indication approval

A decision on whether to recommend approval of an additional indication for Bayer Yakuhin's anticoagulant Xarelto (rivaroxaban) has been put on hold by Japan's Pharmaceutical Affairs and Food Sanitation Council.

Amarin grants Eddingpharm Greater China rights to Vascepa with clinical trial needed

China's Eddingpharm has been granted rights by Amarin to sell hypertriglyceridemia drug Vascepa icosapent ethyl in Greater China.

UPDATED: FDA approves Actavis intrauterine device to prevent pregnancy

Actavis announced FDA approval of its drug delivering intrauterine device, Liletta, as a form of reversible contraception.

Startup Akili partners with nonprofit Autism Speaks to test video game

Akili Interactive Labs has partnered with the nonprofit Autism Speaks to conduct a clinical trial of its cognitive assessment and personalized treatment video game.

China biotech makes FDA 'breakthrough' for HIV drug

China's TaiMed Biologics has won the FDA's breakthrough drug title for its HIV therapy, ibalizumab (TMB-355), making it apparently the first Chinese med to get onto the list.

Japan's Santen files EMA marketing authorization for intravitreal sirolimus eye drug

Japan's Santen Pharmaceutical Co. said the European Medicines Agency (EMA) has accepted the company's Marketing Authorization Application for intravitreal sirolimus, an investigational mTOR inhibitor.

Japan's Chugai partners with Athersys on stem cell ischemic stroke therapy

Chugai and U.S.-based Athersys Inc. agreed to partner in a license agreement on the development of a stem cell therapy for ischemic stroke that includes clinical trial work in Japan.

Otsuka, Sumitomo Dainippon backed Taiho files for EMA marketing authorization for colorectal cancer candidate

Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., has submitted a Marketing Authorization Application to the European Medicines Agency for TAS-102, an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer.

China biotech makes a 'breakthrough' for HIV viral-entry therapy

China's TaiMed Biologics has won the FDA's breakthrough therapy designation for its HIV therapy, ibalizumab (TMB-355), making it apparently the first Chinese med to get onto the list.

Pfizer, Novartis: CDC's MenB nod is too narrow

Pfizer and Novartis have snagged a nod from the CDC's Advisory Committee on Immunization Practices for their recently approved meningitis B vaccines. There's just one problem: It doesn't cover nearly as large a population as the pharma giants would like.