New Market - August 17, 2017
Xbrane’s Spherotide granted market authorization in Iran
Xbrane Biopharma’s partner Pooyesh Darou has been granted market authorization for sales and marketing of Spherotide 1 month formulation in Iran under the local brand name Microrelin. “This is a major milestone for Xbrane as it is the first Market Authorization granted for Spherotide to a local sales and marketing partner. This demonstrates the quality […]
Pharma Business - August 16, 2017
FDA accepts Medivir IND application
Medivir announces that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration). “We are very pleased to have received FDA acceptance for our IND. This is a regulatory milestone for MIV-711 and enables clinical development of MIV-711 in the […]
Pharma Business - August 11, 2017
Novo’s Victoza has been approved in the EU
The European Commission has approved an update to the Victoza (liraglutide) EU label that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment. Victoza is the only GLP-1 that is proven to prevent CV events in people with type 2 diabetes and high […]
Clinical Trials Medtech - May 7, 2017
New medtech legislation comes into force on May 25th
On May 5th the European Commission published two new medtech regulations, the in vitro diagnostic medical device regulation (IVDR) and the medical device regulation (MDR). The regulations will come into force on Thursday May 5th 2017. MDR will replace the former regulations 90/385/EEG and 93/42/EEG and IVDR will replace the former regulation 98/79/EG. Now begins […]
Clinical Trials - May 5, 2017
New EU regulation for clinical trials
The European Council has decided upon a new regulation for clinical trials and in Sweden, the Medical Products Agency together with the six regional ethical review boards, missioned by the government, have made a proposal for a common collaboration structure. Today, according to the operative legislations, the sponsor, the one that applies for permission for […]
Pharma Business - April 24, 2017
Tagrisso receives full approval in the EU
AstraZeneca announces that the European Commission (EC) has granted full marketing authorisation for Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). The full approval for Tagrisso is based on the results of the Phase […]
