Drug Development Pharma - March 24, 2014
Simeprevir receives positive CHMP opinion
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. “The recommendation is one additional step in the global strategy that our […]
Drug Development Pharma - March 24, 2014
Sobi’s Alprolix gets approval in Canada
Health Canada has approved the company’s treatment for the control and prevention of bleeding episodes and routine prophylaxis. Alprolix has been approved for the treatment of adults and children aged 12 and older, with haemophilia B. This is the first regulatory approval worldwide for Alprolix, which is currently under review by regulatory authorities in several other countries, including […]
Drug Development Pharma - March 20, 2014
Lundbeck and Otsuka initiate European launch of Abilify Maintena
The two companies has announced the launch of Abilify Maintena in Europe following approval by the European Commission in November 2013. Denmark is the first European country where Abilify Maintena is fully reimbursed and accessible to people with schizophrenia, and more than ten markets are expected to launch by the end of 2014. Abilify Maintena (aripiprazole) is […]
Drug Development Pharma - March 19, 2014
Novo Nordisk builds new purification pilot plant
Novo Nordisk is increasing its drug development capacity by investing 550 million Danish kroner (100 million US dollars) in a new research and development facility in Bagsværd, Denmark. The purification plant will expand the company’s capacity to produce active pharmaceutical ingredients for a growing number of diabetes drugs under development. The pilot plant will be fully […]
Drug Development Pharma - March 12, 2014
AstraZeneca sells Alderley Park site in Cheshire
AstraZeneca is selling its Alderley Park site in Cheshire, UK, to Manchester Science Parks. Manchester Science Parks (MSP) is a Manchester-based public-private partnership and science park operator. Chris Oglesby, Chairman of MSP and Chief Executive of MSP majority shareholder, Bruntwood, commented in a statement: “We are delighted to have been entrusted with securing the future of Alderley […]
Drug Development Pharma - March 3, 2014
Green light for AstraZeneca’s Bydureon Pen
The FDA has approved the Bydureon Pen as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. It contains the same formulation and […]
