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RSS FeedPosted by Michael Wonder on 07 Apr 2016
CHMP issues positive opinion to include new data in European label for Xtandi (enzalutamide)
7 April 2016 - Medivation and Astellas Pharma Inc. announced today that the CHMP of the EMA has issued a positive ...
Posted by Michael Wonder on 07 Apr 2016
Giotrif (afatinib dimaleate) approved in Europe as new oral treatment option for patients with squamous cell carcinoma of the lung
7 April 2016 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation for Giotrif (afatinib dimaleate) for ...
Posted by Michael Wonder on 07 Apr 2016
Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP
7 April 2016 - Novartis announced today that the European Commission (EC) has approved Revolade (eltrombopag olamine) for the treatment of ...
Posted by Michael Wonder on 06 Apr 2016
March 2016 NCE registrations - TGA
7 April 2016 - The TGA registered three new medicines and one new combination product in March 2016: lumacaftor with ...
Posted by Michael Wonder on 06 Apr 2016
Genvoya in HIV: positive effects predominate in some adults, negative effects in others says Germany's IQWiG
1 April 2016 - The fixed-dose combination of the drugs elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide has been available under the ...
Posted by Michael Wonder on 06 Apr 2016
European Commission approves expanded use of Opdivo (nivolumab) to include previously treated metastatic non-squamous non-small cell lung cancer
6 April 2016 - Bristol-Myers Squibb Company announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for locally advanced ...
Posted by Michael Wonder on 06 Apr 2016
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for previously treated advanced renal cell carcinoma
6 April 2016 - Bristol-Myers Squibb Company announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional ...
Posted by Michael Wonder on 05 Apr 2016
FDA approves Inflectra, a biosimilar to Remicade
5 April 2016 - The U.S. FDA today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This ...
Posted by Michael Wonder on 05 Apr 2016
U.S. Food and Drug Administration approves Descovy (emtricitabine, tenofovir alafenamide), Gilead’s third TAF-based HIV therapy
4 April 2016 - Gilead Sciences, Inc. today announced that the U.S. FDA has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 ...
Posted by Michael Wonder on 04 Apr 2016
Efmoroctocog alfa for haemophilia A: IQWIG says an additional benefit is not proven
1 April 2016 - Efmoroctocog alfa (trade name: Elocta) has been approved since November 2015 for people with type A haemophilia. ...
Posted by Michael Wonder on 03 Apr 2016
Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion
1 April 2016 - The CHMP has issued a positive opinion for the marketing authorization of Flixabi (infliximab). Previously known as ...
Posted by Michael Wonder on 02 Apr 2016
HIV-positive children and adolescents: additional benefit of rilpivirine not proven
1 April 2016 - Under the trade name Edurant, rilpivirine hydrochloride as single agent has been approved already since 2011 for ...
Posted by Michael Wonder on 02 Apr 2016
Bristol-Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treatment of advanced melanoma
1 April 2016 - Bristol-Myers Squibb Company announced today that the CHMP has recommended the approval of Opdivo in combination with ...
Posted by Michael Wonder on 01 Apr 2016
New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for a new gene therapy ...
Posted by Michael Wonder on 01 Apr 2016
First oral treatment for Fabry disease recommended for approval in the EU
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for Galafold (migalastat hydrochloride) for ...