Theravance, Mylan to develop and commercialize new LAMA compound to treat COPD
In multiple Phase II trials, TD-4208 has shown positive top-line results in COPD patients, and recently the FDA had agreed to the design of the Phase III registrational
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
Factor VIIa-CTP is a new, long-acting recombinant Factor VIIa using the company’s proprietary technology to extend its circulatory half-life without the use of polymers, encapsulation techniques or nanoparticles.