Octagam 10% [immune globulin intravenous (human) 10% (100mg/ml) liquid preparation] helps in rapidly raising platelet counts to control or prevent bleeding in chronic ITP patients. The FDA approval
Currently, nintedanib is under FDA and European Medicines Agency (EMA review) to be indicated for the treatment of IPF. Boehringer Ingelheim chief medical officer Klaus Dugi said the
The company is focused on developing first-in-class platform of therapeutics to address pain at its molecular roots. With ADYX-003, the company will build on the results of the
By using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology, the companies will seek to use the power of the body’s own immune system to attack
Imugene’ cancer immunotherapy vaccine candidate HER-Vaxx is scheduled to enter into a Phase I/II clinical trial in 2015. Under the deal, Mymetics will use its strong experience and
FDA also said that the NDA would be treated as a Class 2 resubmission; hence, the new user fee goal date is 30 December 2014. In April 2014,
The trial is designed to confirm the positive results previously reported for ZS003, a phase III trial in which once-daily doses of ZS-9 maintained potassium levels within the
The sNDA for Olysio and sofosbuvir was submitted in May by the company’s strategic partner Janssen Research & Development. The regulatory submission is based on data from the
Harlan provides general and specialty toxicology services through its Contract Research Services (CRS) business. Under the deal, Harlan CRS will use Fluofarma’s expertise in high content analysis, biomarkers
The Brazilian pharmaceutical firm EMS will be responsible for securing regulatory and pricing approval, as well as the marketing and supply of the medication, in that territory. In
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