Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product ...
The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to ...
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly ...
Tags: Veloxis Pharmaceuticals, New Drug Application, Envarsus®
Astellas and IBL Concludes Co-Research Agreement Regarding Pharmaceutical Applications of Recombinant Human Proteins Made Using transgenic Silkworms Tokyo, December 25, 2013 - Astellas Pharma Inc. ("Astellas") and Immuno-Biological ...
Alzheon announced the launch of the company, the securing of initial private financing, and the signing of an exclusive license agreement to a novel clinical drug candidate for Alzheimer’s disease, a family of analogs, and a drug ...
Tags: Alzheon, Alzheimer's Disease
Astellas Pharma US has launched ASTAGRAF XL (tacrolimus extended-release capsules), the first once-daily oral tacrolimus formulation, in the US market. The new product is indicated for the prophylaxis of organ rejection in patients ...
The Bill & Melinda Gates Foundation has granted $1.15m funding to a global public-private partnership (PPP), to develop a new pediatric formulation to fight schistosomiasis, commonly known as bilharzia, in preschool children. Formed in ...
Tags: Schistosomiasis Drug, Medicine
Astellas Pharma has announced the availability of Xtandi (enzalutamide), a new treatment for advanced prostate cancer in patients who have failed on first-line hormonal treatments and docetaxel chemotherapy, in the UK. Administered ...
Tags: Astellas, Cancer Medication
China’s National Development and Reform Commission (NDRC) has launched a probe into drug pricing at 60 domestic and international pharmaceutical companies, as the country expands its healthcare coverage, Financial Times reported. The ...
Tags: Drugmakers, Medicine
Toa Eiyo has received manufacturing and marketing authorization for Bisono Tape 4mg and 8mg medicines (Bisono Tape) in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW). Developed by Nitto Denko in partnership with Toa ...
The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, ...
Astellas Pharma and Zeria Pharmaceutical are set to launch Acofide Tablets 100mg (acotiamide hydrochloride hydrate) in Japan on 6 June for treating functional dyspepsia (FD). The world's first FD treatment, Acofide demonstrated efficacy ...
Astellas Pharma and Medivation have announced the Health Canada approval of Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer. The oral, once-daily androgen receptor inhibitor is indicated for ...
Tags: Astellas Pharma, Medicine
Basilea Pharmaceutica has obtained FDA orphan drug status to isavuconazole, an investigational intravenous and oral broad-spectrum antifungal, for the treatment of invasive aspergillosis. Isavuconazole is being investigated in phase 3 ...
Astellas Pharma and Medivation have announced the submission of application for marketing approval of enzalutamide in Japan for the treatment of prostate cancer. The application was filed by Astellas with the Ministry of Health, Labour ...
Tags: Astellas, Marketing Application