Blog
RSS FeedPosted by Michael Wonder on 29 Aug 2018
FDA pushes for development of non-opioid pain medications
29 August 2018 - The FDA is planning new steps to encourage the development of nonaddictive alternatives to opioid pain ...
Posted by Michael Wonder on 29 Aug 2018
Evolus receives acceptance of FDA BLA resubmission for DWP-450
29 August 2018 - Application designated as Class 2 by U.S. FDA and assigned 2 February 2019 PDUFA date. ...
Posted by Michael Wonder on 29 Aug 2018
FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernise drug development and promote innovation in drugs targeted to unmet needs
29 August 2018 - Today, the U.S. FDA announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which ...
Posted by Michael Wonder on 29 Aug 2018
Towards improving the availability of medicines in the EU
29 August 2018 - EU-wide task force publishes work programme 2019/20 and prepares multi-stakeholder workshop. ...
Posted by Michael Wonder on 29 Aug 2018
European Commission approves Novartis combination therapy Tafinlar and Mekinist for adjuvant treatment of BRAF V600 mutation-positive melanoma
29 August 2018 - Approval based on COMBI-AD study demonstrating greater than 50% reduction in risk of disease recurrence or death ...
Posted by Michael Wonder on 29 Aug 2018
Duzallo, a fixed-dose combination therapy for gout, approved in Europe
28 August 2018 - Grünenthal announced that the European Commission has followed the positive opinion of the CHMP and granted ...
Posted by Michael Wonder on 28 Aug 2018
Comparison of two treatment models: precision medicine and preventive medicine
28 August 2018 - In an effort to improve the risk-benefit profile of therapies in clinical care, precision medicine seeks to ...
Posted by Michael Wonder on 28 Aug 2018
Data enclaves for sharing information derived from clinical and administrative data
28 August 2018 - The promise that big data will transform health care has yet to be fulfilled. ...
Posted by Michael Wonder on 28 Aug 2018
Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements
28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...
Posted by Michael Wonder on 28 Aug 2018
You may start seeing drug prices in ads, but will you understand the point?
28 August 2018 - Late last week, the U.S. Senate passed an amendment to the spending bill that would require ...
Posted by Michael Wonder on 28 Aug 2018
Co-ordinated clinical trials could help more Australians
29 August 2018 - Every year about 1000 clinical trials start in Australia, with cancer the most frequently targeted condition. ...
Posted by Michael Wonder on 28 Aug 2018
Akcea and Ionis receive complete response letter for Waylivra from FDA
27 August 2018 - Akcea Therapeutics today announced that they received a complete response letter from the Division of Metabolism and ...
Posted by Michael Wonder on 28 Aug 2018
Loxo Oncology announces submission of European marketing authorisation application for larotrectinib
27 August 2018 - Loxo Oncology today announced that its collaboration partner, Bayer, has submitted a marketing authorisation application for larotrectinib ...
Posted by Michael Wonder on 28 Aug 2018
Ultragenyx announces approval of Mepsevii (vestronidase alfa) in Europe for the treatment of mucopolysaccharidosis VII
27 August 2018 - Mepsevii, an enzyme replacement therapy, is the first treatment approved in the EU for mucopolysaccharidosis VII. ...
Posted by Michael Wonder on 28 Aug 2018
Yescarta (axicabtagene ciloleucel) receives European marketing authorisation for the treatment of relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy
27 August 2018 - New option for adult patients in Europe as axicabtagene ciloleucel becomes the first CAR T to receive ...