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RSS FeedPosted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...
Posted by Michael Wonder on 12 Jun 2018
FDA approves addition of positive overall survival data from Phase 3 ASPIRE trial to Kyprolis (carfilzomib) label
11 June 2018 - Kyprolis, lenalidomide and dexamethasone extended median overall survival in relapsed or refractory multiple myeloma patients to 48 ...
Posted by Michael Wonder on 09 Jun 2018
Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005
6 June 2018 - Well conducted clinical trials are widely regarded as the best source of evidence on the efficacy and ...
Posted by Michael Wonder on 09 Jun 2018
Easier drug approval isn’t cutting drug prices
8 June 2018 - Dr. Scott Gottlieb, the commissioner of the FDA, recently vowed to bring “new science” to market ...
Posted by Michael Wonder on 09 Jun 2018
AbbVie announces U.S. FDA approval of Venclexta (venetoclax tablets) in combination with rituximab as a fixed duration treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma patients who have received one prior therapy
8 June 2018 - Patients receiving Venclexta plus rituximab achieved a high overall response rate of 92%. ...
Posted by Michael Wonder on 07 Jun 2018
FDA approves Genentech’s Rituxan (rituximab) for pemphigus vulgaris
7 June 2018 - Rituxan is now FDA-approved to treat four auto-immune diseases. ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 07 Jun 2018
The ‘right to try’ law says yes, the drug company says no
6 June 2018 - Vibhav Rangarajan and Sonal Patel, doctors in Chicago, learned in April that their 2-year-old daughter, Radha, has ...
Posted by Michael Wonder on 07 Jun 2018
Intra-Cellular Therapies initiates rolling submission of new drug application for lumateperone for treatment of schizophrenia
6 June 2018 - Intra-Cellular Therapies today announced the initiation of a rolling submission of its new drug application with the ...
Posted by Michael Wonder on 07 Jun 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of rhabdomyosarcoma
6 June 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131, ...
Posted by Michael Wonder on 07 Jun 2018
Partner Therapeutics announces US FDA approval of Leukine (sargramostim) for the treatment of acute radiation syndrome
6 June 2018 - Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and paediatric ...
Posted by Michael Wonder on 06 Jun 2018
Clinical trial participants’ views of the risks and benefits of data sharing
7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...
Posted 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 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 ...