Blog
RSS FeedPosted by Michael Wonder on 06 Jun 2018
FDA’s new efforts to advance biotechnology innovation
6 June 2018 - Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human ...
Posted by Michael Wonder on 06 Jun 2018
Nohla receives EMA PRIME designation for dilanubicel (NLA101) to treat haematopoietic stem cell transplant patients
6 June 2018 - First product to achieve PRIME designation for haematopoietic stem cell transplant patients. ...
Posted by Michael Wonder on 06 Jun 2018
Audentes announces PRIME designation granted by the EMA to AT132 for the treatment of X-linked myotubular myopathy
5 June 2018 - Audentes Therapeutics today announced that the EMA has granted PRIME designation to AT132 for the treatment ...
Posted by Michael Wonder on 05 Jun 2018
FDA proposes process modernisation to support new drug development
4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge ...
Posted by Michael Wonder on 05 Jun 2018
Embracing competition to empower biosimilars
5 June 2018 - In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease, ...
Posted by Michael Wonder on 05 Jun 2018
Postmarket studies required by the US FDA for new drugs and biologics approved between 2009 and 2012: cross-sectional analysis
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
Posted by Michael Wonder on 05 Jun 2018
FDA grants priority review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors
5 June 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 05 Jun 2018
FDA expands Lilly's Alimta (pemetrexed) label to include combination with Keytruda (pembrolizumab) and carboplatin as first-line treatment for metastatic non-squamous non-small cell lung cancer, irrespective of PD-L1 expression
5 June 2018 - New approval based on KEYNOTE-021, cohort G1, results. ...
Posted by Michael Wonder on 05 Jun 2018
Mabion completes marketing authorisation application for flagship drug, MabionCD20, to the EMA
5 June 2018 - • Mabion is first Polish biotech company to successfully complete development of a biosimilar drug independently and to ...
Posted by Michael Wonder on 05 Jun 2018
Evoke announces FDA submission of new drug application for Gimoti
4 June 2018 - Evoke Pharma today announced the submission of its 505(b)(2) new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 05 Jun 2018
Lupin submits marketing authorisation application for etanercept biosimilar in Europe
23 May 2018 - Pharma major Lupin announced today that its marketing authorization application for a biosimilar of etanercept has been ...
Posted by Michael Wonder on 04 Jun 2018
Statement from FDA Commissioner on proposed modernisation of FDA’s drug review office
4 June 2018 - Scientific and medical advances are giving the FDA more opportunities to more fully address diseases and ...
Posted by Michael Wonder on 04 Jun 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
4 June 2018 - The U.S. FDA today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the ...
Posted by Michael Wonder on 04 Jun 2018
Europe's drug agency warns of bigger staff losses in Brexit move
1 June 2018 - Regulator says it underestimated challenges of relocation. ...