GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA
Sorrento Therapeutics Inc., of San Diego, and Igdrasol Inc., of Irvine, Calif., said they acquired exclusive distribution rights from Samyang Biopharmaceuticals, a South Korean firm, to Cynviloq (marketed as Genexol-PM in South Korea) in the 27 countries of the European Union
ProQinase GmbH, of Freiburg, Germany, and Mercachem BV, of Nijmegen, the Netherlands, received a €2.5 million (US$3.24 million) grant from the European Union's Eurostars program to support their joint efforts to establish and expand a small molecule drug discovery platform that will combine biological and pharmacological assay systems with chemical space libraries targeted against most prominent epigenetic enzyme families
to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif
BioWorld International | Wednesday, April 17, 2013
Sanofi Pasteur Ltd., of Lyon, France, the vaccines division of Sanofi SA, said a decentralized marketing authorization application has been accepted for review in the European Union (EU) countries for a quadrivalent formulation of Vaxigrip, Sanofi Pasteur's seasonal inactivated split-virion influenza vaccine produced at its facility in Val de Reuil, France
Gilead said it will file for regulatory approval of sofosbuvir in other territories during the second quarter, including the European Union, where the European Medicines Agency accepted the company's request for accelerated assessment
The company plans to submit an application for registration in the European Union by the end of April...Alimera said the resubmission focuses on the safety aspects of Iluvien and the population of patients with chronic DME, the group for which marketing approval of Iluvien was granted in six European Union countries
In separate news, Astellas signed a deal to access the TSUBAME2.0 supercomputer at the Tokyo Institute of Technology to discover candidates for NTDs caused by dengue virus...In other news, The Nasdaq OMX Stockholm's listing committee approved the listing of NeuroVive's shares
BioWorld International | Wednesday, March 27, 2013
Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...Under the agreement, Lundbeck will have the right to promote all formulations of
BioWorld International | Wednesday, March 13, 2013
Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable
Under the agreement, Lundbeck will have the right to promote all formulations of Abilify currently marketed, sold or distributed by Otsuka in the European Union
PlacMalVac, a project coordinated by the University of Copenhagen, Denmark, received an FP7 European Union grant supporting the first clinical trial of a VAR2CSA-based vaccine targeting malaria parasites that infect pregnant women
Exelixis Inc., of South San Francisco, partnered with Swedish Orphan Biovitrum AB (Sobi), of Stockholm, Sweden, to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European Union and potentially other countries...Vivus Inc., of Mountain View, Calif., said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed its Oct. 18, 2012, decision to decline the Marketing Authorization Application (MAA) for Qsiva
In the European Union, Adasuve 4.5 mg and 9.1-mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder
GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA