Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2015
Novartis' Zykadia clears first step in UK early access scheme
Novartis’ investigational lung cancer drug Zykadia (ceritinib) been awarded Promising Innovative Medicine status in the UK, completing the first stage ...
Posted by Michael Wonder on 05 Aug 2015
The European Commission approves Aloxi (palonosetron hydrochloride) injection to prevent nausea and vomiting due to chemotherapy in children as young as one month
Helsinn Group, the Swiss Group focused on building quality cancer care, today announces that the European Commission has endorsed the ...
Posted by Michael Wonder on 05 Aug 2015
Novartis drug Farydak recommended by CHMP for EU approval to treat multiple myeloma, providing patients a new mechanism of action
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ...
Posted by Michael Wonder on 05 Aug 2015
Novartis' heart failure medicine LCZ696 granted accelerated assessment by CHMP in Europe
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an ...
Posted by Michael Wonder on 05 Aug 2015
Bayer submits marketing authorization application in Europe for recombinant factor VIII product (BAY 81-8973) for the treatment of hemophilia A in adults and children
Bayer HealthCare today submitted an application for marketing authorization to the European Medicines Agency (EMA) for BAY 81-8973, a recombinant ...
Posted by Michael Wonder on 05 Aug 2015
Bayer receives European approval for Gadovist (gadobutrol) for use in pediatric patients less than 2 years of age
Bayer HealthCare announced today that Gadovist (gadobutrol) has received a label extension in the European Union (EU) for diagnostic use with ...
Posted by Michael Wonder on 05 Aug 2015
New indication for Spiriva (tiotropium) Respimat in the EU may offer millions of adults a significant advance in asthma care
Boehringer Ingelheim today announced that the indication for Spiriva (tiotropium) Respimat in asthma has been accepted by the regulatory authorities in the ...
Posted by Michael Wonder on 05 Aug 2015
Lynparza (olaparib) receives positive CHMP opinion in the EU for the maintenance treatment of BRCA-mutated platinum sensitive relapsed ovarian cancer
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...
Posted by Michael Wonder on 05 Aug 2015
Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned
Today, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced its decision ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab), the first and only PD-1 checkpoint inhibitor approved in Europe, for both first-line and previously-treated advanced melanoma patients
Bristol-Myers Squibb Company today announced that the European Commission has approved Opdivo, a PD-1 immune checkpoint inhibitor, for the treatment of advanced ...
Posted by Michael Wonder on 05 Aug 2015
GE Healthcare announces European Union approval of Vizamyl (Flutemetamol (18F) solution for injection) for PET imaging of beta amyloid plaque in suspected Alzheimer’s disease
GE Healthcare announced today that Vizamyl (flutemetamol (18F) solution for injection) has received marketing authorisation from the European Commission as a ...
Posted by Michael Wonder on 05 Aug 2015
Praluent recommended for approval to lower cholesterol
The European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for Praluent (alirocumab) to lower high levels of cholesterol ...
Posted by Michael Wonder on 05 Aug 2015
Zykadia recommended for approval in advanced non small cell lung cancer
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Zykadia (ceritinib). Zykadia is recommended for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
Biogen Idec and Sobi announce European Medicines Agency validates Elocta (rFVIIIFC) marketing authorization application for review
Biogen Idec and Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) ...
Posted by Michael Wonder on 05 Aug 2015
FDA, European Commission and EMA reinforce collaboration to advance medicine development and evaluation
Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) ...