Drug Development Pharma - October 29, 2013
Pharmalink receives US orphan drug designation
Pharmalink receives US orphan drug designation for Busulipo, its novel oncology product for bone marrow transplantation. Busulipo is a best-in-class conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT; also known as bone marrow transplantation). The company is currently preparing for registration trials with an optimized formulation of Busulipo as […]
Drug Development Pharma - October 24, 2013
Ferring’s Misodel approved for labour induction
Ferring Pharmaceuticals have announced that its MISODELTM (misoprostol) removable, controlled-release vaginal delivery system for labour induction has successfully completed the European Decentralised Procedure. MISODELTM has been approved for induction of labour in women with an unfavourable cervix, from 36 weeks of gestation, in whom induction is clinically indicated. An unfavourable cervix is a cervix that […]
Drug Development Pharma - October 9, 2013
Takeda and Lundbeck announce FDA approval of Brintellix
Takeda Pharmaceutical Company and H. Lundbeck A/S jointly have announced that the U.S. Food and Drug Administration (FDA) has approved Brintellix (vortioxetine) for the treatment of adults with major depressive disorder (MDD). “MDD is a multifaceted disorder that encompasses emotional, physical and cognitive symptoms that may make it challenging to treat,” said Michael Thase, M.D., […]
Drug Development Pharma - September 25, 2013
Otsuka and Lundbeck receive positive CHMP opinion for Abilify Maintena(r) in schizophrenia
Lundbeck and Otsuka today announced a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. “Abilify Maintena has been available in the US for […]
Drug Development Pharma - September 10, 2013
Novartis acquires drug candidate from Camurus
Novartis has exercised its option to acquire an exclusive license for the further development and worldwide commercialization of CAM2029 for treatment of patients with acromegaly and neuroendocrine tumors (NETs). The license also covers additional future products based on the Camurus’ FluidCrystal Injection depot technology. The option exercise is the next stage in the collaboration, option […]
Drug Development Pharma - September 6, 2013
Medivir discontinues collaboration with Daewoong
The company has announced that it has discontinued the development of its hepatitis B compound MIV-210 based on a joint decision with Daewoong Pharmaceutical. In the collaboration agreement Daewoong has been responsible for the research and development. MIV-210 has a demonstrably competitive antiviral activity but, like other drugs of this class, does not completely eradicate […]
