Drug Development Pharma - November 25, 2013
US approval of Simeprevir
Medivir has received US approval of its Simeprevir for the treatmeant of hepatitis C. On Friday 22 Medivir and Janssen’s drug candidate Simeprevir was approved for the US market by the Food and Drug Administration (FDA). The product will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with […]
Drug Development Pharma - November 25, 2013
European approval for Lundbeck and Otsuka
Lundbeck and Otsuka Pharmaceutical Co., Ltd. (Otsuka) have announced marketing authorisation approval from the European Commission for Abilify Maintena (aripiprazole). Abilify Maintena is an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. “Studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia […]
Drug Development Pharma - November 21, 2013
Medivir’s Simeprivir approved in Canada
Medivir AB has announced that Health Canada has approved as a new treatment for hepatitis C. Simeprevir will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment‑naïve or who have failed previous interferon therapy […]
Drug Development Pharma - November 20, 2013
Sobi gets EU approval for Kineret
Sobi has announced that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2013, states the company. The approval was based on the outcome […]
Drug Development Pharma - November 19, 2013
Naloxegol reaches milestone
AstraZeneca has announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol. The investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain […]
Drug Development Pharma - November 18, 2013
Algeta & Bayer granted EU marketing authorization
Algeta and Bayer have received marketing authorisation from the European Commission for Xofigo for the treatment of prostrate cancer patients with bone metastases. According to Oslo Cancer Cluster, the marketing authorization provides approval for the commercialization of Xofigo in all 28 countries of the EU, and in Norway, Iceland and Liechtenstein following national approval. The decision […]
