Blog
RSS FeedPosted by Michael Wonder on 05 May 2018
Novartis matches Gilead on price in new CAR-T use
3 May 2018 - Novartis’ CAR-T therapy Kymriah will be available in the US to adults with relapsed large B-cell ...
Posted by Michael Wonder on 05 May 2018
Gottlieb pushes back against criticism of ‘breakthrough’ designation
4 May 2018 - FDA Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that ...
Posted by Michael Wonder on 05 May 2018
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
4 May 2018 - The U.S. FDA approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, ...
Posted by Michael Wonder on 03 May 2018
FDA updates Trintellix (vortioxetine) label to include data showing improvement in processing speed, an important aspect of cognitive function in acute major depressive disorder
2 May 2018 - Trintellix (vortioxetine) is the first FDA-approved treatment for MDD to have data in the U.S. Prescribing Information ...
Posted by Michael Wonder on 03 May 2018
Migraine drug delay would compound Teva's troubles
2 May 2018 - Teva Pharmaceutical Industries is counting on its new migraine treatment to haul it out of the ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 03 May 2018
RegenxBio receives FDA fast track designation for RGX-121 gene therapy for the treatment of mucopolysaccharidosis Type II
2 May 2018 - Phase I/II clinical trial expected to enrol children with MPS II. ...
Posted by Michael Wonder on 02 May 2018
Too many cancer drugs? Crowded market gives investors pause
2 May 2018 - In London’s world-famous Great Ormond Street children’s hospital, Dr. Karin Straathof is excited about a new ...
Posted by Michael Wonder on 02 May 2018
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
2 May 2018 - Sandoz, a Novartis division, announced today that the US FDA has issued a complete response letter ...
Posted by Michael Wonder on 02 May 2018
FDA releases Theratechnologies from post-approval commitments related to Egrifta (tesamorelin for injection)
1 May 2018 - Theratechnologies today announced that the FDA has released Theratechnologies from post-approval commitments related to the approval ...
Posted by Michael Wonder on 01 May 2018
Acceleron receives FDA fast track designation for ACE-083 in facioscapulohumeral muscular dystrophy
1 May 2018 - Acceleron Pharma today announced that the U.S. FDA has granted fast track designation to ACE-083, a ...
Posted by Michael Wonder on 01 May 2018
Scynexis' oral SCY-078 receives FDA QIDP and fast track designations for the treatment of VVC and prevention of recurrent VVC
1 May 2018 - Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018. ...
Posted by Michael Wonder on 01 May 2018
Kymriah (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
1 May 2018 - Kymriah is the only CAR-T therapy FDA-approved for two distinct indications - in non-Hodgkin lymphoma (NHL) and ...