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RSS FeedPosted by Michael Wonder on 11 Nov 2019
‘Regulatory science to 2025’: live broadcast of post-consultation workshop
11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...
Posted by Michael Wonder on 11 Nov 2019
TGA approved terminology for therapeutic goods
11 November 2019 - The Therapeutic Goods Administration develops and maintains approved terminology to ensure the accuracy and consistency of ...
Posted by Michael Wonder on 10 Nov 2019
Patient perspective is vital to FDA's work
7 November 2019 - As an oncologist, I was eager to come work at the U.S. FDA, where I knew ...
Posted by Michael Wonder on 09 Nov 2019
Xeomin Cosmetic licensed for additional indications In Canada
7 November 2019 - Merz Pharma has announced that Health Canada has provided marketing authorization for additional indications for Xeomin ...
Posted by Michael Wonder on 09 Nov 2019
Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19
7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...
Posted by Michael Wonder on 09 Nov 2019
Cassiopea announces FDA acceptance of its new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years
8 November 2019 - Cassiopea announced today the U.S. FDA has accepted for review the new drug application for clascoterone cream ...
Posted by Michael Wonder on 09 Nov 2019
EIP Pharma announces U.S. FDA grants fast-track designation to neflamapimod as a treatment for dementia with Lewy Bodies
7 November 2019 - EIP Pharma today announced that the Division of Neurology Products of the U.S. FDA has granted ...
Posted by Michael Wonder on 09 Nov 2019
Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen
7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...
Posted by Michael Wonder on 09 Nov 2019
Janssen announces Health Canada approval of Imbruvica (ibrutinib) in combination with obinutuzumab for treatment naïve patients with chronic lymphocytic leukaemia
8 November 2019 - Patients experienced a 77% reduction in risk of disease progression or death compared to chlorambucil plus obinutuzumab. ...
Posted by Michael Wonder on 09 Nov 2019
Janssen announces submission of supplemental new drug application to U.S. FDA seeking approval of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
8 November 2019 - Supplemental new drug application -- submitted through FDA real-time oncology review program -- is based on positive ...
Posted by Michael Wonder on 09 Nov 2019
Teva and Celltrion announce the availability of Truxima (rituximab-abbs) injection, the first biosimilar to Rituxan (rituximab) in the United States
7 November 2019 - Truxima available week of November 11. ...
Posted by Michael Wonder on 09 Nov 2019
FDA approves first therapy to treat patients with rare blood disorder
8 November 2019 - Today the U.S. FDA granted approval to Reblozyl (luspatercept–aamt) for the treatment of anaemia (lack of red ...
Posted by Michael Wonder on 07 Nov 2019
The FDA needs to set standards for using artificial intelligence in drug development
7 November 2019 - Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many ...
Posted by Michael Wonder on 07 Nov 2019
EMA validates Bratovi, Mektovi application for some mCRC
7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...
Posted by Michael Wonder on 07 Nov 2019
The U.S. insulin crisis — rationing a lifesaving medication discovered in the 1920s
7 November 2019 - The members of the team that discovered insulin sold the patent to the University of Toronto for ...