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RSS FeedPosted by Michael Wonder on 05 Aug 2015
European Commission approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the treatment of HIV-1 infection in adults
Bristol-Myers Squibb Company announced today that the European Commission has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014
Thirty-nine medicines for human use were recommended for marketing authorisationby the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) ...
Posted by Michael Wonder on 05 Aug 2015
Humira (adalimumab) approved by European Commission for moderate to severe hidradenitis suppurativa (HS)
AbbVie, a global biopharmaceutical company, today announced that Humira (adalimumab) is approved for the treatment of active moderate to severe hidradenitis ...
Posted by Michael Wonder on 05 Aug 2015
Orexigen's Mysimba approved in Europe for the treatment of obesity
Orexigen Therapeutics, Inc. today announced that the European Commission has granted marketing authorization for Mysimba (naltrexone hydrochloride / bupropion hydrochloride prolonged release) as an adjunct to ...
Posted by Michael Wonder on 05 Aug 2015
Draft EMA reflection paper on the use of patient reported outcome measures in oncology studies
The importance of the patient’s point of view on their health status is fully acknowledged and such information may in ...
Posted by Michael Wonder on 05 Aug 2015
EMA to encourage use of scientific advice for post-authorisation safety studies
The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorisation safety studies (PASS) ...
Posted by Michael Wonder on 05 Aug 2015
Publication of clinical reports
The EMA has decided to publish the clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the ...
Posted by Michael Wonder on 05 Aug 2015
Science, medicines, health: patients at the heart of future innovation
The European Medicines Agency (EMA) marks its 20th anniversary with a scientific conference on Wednesday, 18th of March. ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency welcomes new Head of Administration
The European Medicines Agency is pleased to announce the appointment of Luc Vanheel as Head of the Administration Division as of ...
Posted by Michael Wonder on 05 Aug 2015
ViiV Healthcare receives EU marketing authorisation for Triumeq
ViiV Healthcare announced today that the European Commission (EC) has granted marketing authorisation for Triumeq (dolutegravir 50 mg / abacavir 600 ...
Posted by Michael Wonder on 05 Aug 2015
EMA Management Board: highlights of March 2015 meeting
The European Medicines Agency’s (EMA) Management Board elected Dr Christa Wirthumer-Hoche, the Head of the Austrian Medicines and Medical Devices ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency accepts application seeking new indication for Prevenar 13 for prevention of pneumococcal pneumonia in adults
Pfizer Inc. announced today that the European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar ...
Posted by Michael Wonder on 05 Aug 2015
UCB announces US and EU regulatory filings for the investigational antiepileptic drug brivaracetam
UCB today announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam. In the US, the ...
Posted by Michael Wonder on 05 Aug 2015
First treatment recommended for rare bone disease
The European Medicines Agency (EMA) has recommended granting a marketing authorisation under exceptional circumstances for Strensiq (asfotase alfa), for the ...
Posted by Michael Wonder on 05 Aug 2015
Roche's Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer
Roche today announced that the European Commission (EC) has approved the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy for ...