Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.
Early and efficient communication is the key to cutting approval times says the US FDA, which published a draft best practices guide for drug firms this week.
Last week, a new chapter of PhRMA’s Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results went into effect, detailing efforts to raise awareness around expanded access programs, which provide investigational drugs for...
The China Food and Drug Administration (CFDA) has accepted for review an Investigational New Drug (IND) application for WuXi and MedImmune's novel anti-IL6 monoclonal antibody (mAb) for rheumatoid arthritis.
A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.
The expansion of CoreRx’s Clearwater, Florida facility will allow for hormone development, clinical trial and commercial manufacturing, and create about 25 new jobs.
US-based drug delivery firm, BioDelivery Sciences International
(BDSI), has asked for approval to start clinical trials of a soya
bean-based delivery technology that would lead to the first oral
version of amphotericin B, a widely-used...
Novartis has announced the formation of a collaboration with Anadys
Pharmaceuticals to develop Hepatitis C (HCV) and hepatitis B (HBV)
therapeutics in a deal worth at least $570 million (€466 million).
This week has seen several companies unveil significant capital
investments in new production and research units, and once again
production facilities for biological drugs - currently said to be
suffering from undercapacity - feature...
