Blog
RSS FeedPosted by Michael Wonder on 09 Apr 2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
9 April 2020 - As part of its health threat plan activated to fight COVID-19, the EMA has finalised and ...
Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...
Posted by Michael Wonder on 09 Apr 2020
Bayer launches pre-filled syringe to administer eye medication Eylea in Europe
8 April 2020 - The European Medicines Agency has granted approval for the new Eylea (aflibercept) injection pre-filled syringe. ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...
Posted by Michael Wonder on 08 Apr 2020
Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1
7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...
Posted by Michael Wonder on 07 Apr 2020
Global regulators discuss observational studies of real world data for COVID-19 medicines
7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...
Posted by Michael Wonder on 07 Apr 2020
Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020
7 April 2020 - It is EMA's top priority to help save lives during the pandemic by expediting the development ...
Posted by Michael Wonder on 07 Apr 2020
Esperion announces European Commission approval of the Nilemdo (bempedoic acid) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in Europe in Almost Two Decades for Indicated Patients. ...
Posted by Michael Wonder on 07 Apr 2020
European Commission approves Takeda’s Alunbrig (brigatinib) as a first-line treatment for ALK+ NSCLC
6 April 2020 - Approval based on positive results from the Phase 3 ALTA-1L trial showing Alunbrig demonstrated superior overall and ...
Posted by Michael Wonder on 06 Apr 2020
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
6 April 2020 - The continued availability of medicines, in particular those used for patients with COVID-19, is of critical ...
Posted by Michael Wonder on 06 Apr 2020
Rybelsus (oral semaglutide) approved for the treatment of adults with type 2 diabetes in the EU
4 April 2020 - Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Rybelsus (oral ...
Posted by Michael Wonder on 03 Apr 2020
EMA provides recommendations on compassionate use of remdesivir for COVID-19
3 April 2020 - During an extraordinary virtual meeting held on 2 April 2020, EMA’s CHMP gave recommendations on how ...
Posted by Michael Wonder on 03 Apr 2020
International regulators discuss available knowledge supporting COVID-19 medicine development
3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...
Posted by Michael Wonder on 02 Apr 2020
Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)
2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to ...