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RSS FeedPosted by Michael Wonder on 05 Aug 2015
GSK receives FDA approval of an additional Promacta (eltrombopag) indication for use in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy
GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits applications in the US and Europe for Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA grants Breakthrough Therapy Designation for Roche's investigational cancer immunotherapy MPDL3280A (anti-PDL1) in non-small cell lung cancer
Roche announced today that it has received a second Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Juventas Therapeutics granted FDA fast track designation and phase 2b protocol allowance for novel heart failure gene therapy
Juventas Therapeutics, Inc., a clinical-stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body, ...
Posted by Michael Wonder on 05 Aug 2015
Value in cancer care
ASCO has released a conceptual framework for assessing the value of new cancer therapies based on treatment benefits, toxicities, and costs. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for most common form of advanced skin cancer
The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that ...
Posted by Michael Wonder on 05 Aug 2015
Vivus and Auxilium announce FDA approval of Stendra sNDA; Stendra now first and only oral erectile dysfunction treatment approved to be taken approximately 15 minutes before sexual activity
VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces regulatory submissions for mepolizumab in severe eosinophilic asthma
GlaxoSmithKline plc today announced that it has filed regulatory submissions in the USA and Europe for mepolizumab for approval as a ...
Posted by Michael Wonder on 05 Aug 2015
Dyax Corp. receives FDA breakthrough therapy designation for DX-2930 for prevention of attacks of hereditary angioedema
Dyax Corp. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the investigation of DX-2930 for hereditary ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers hepatitis C drug to lose special status from FDA
Bristol-Myers Squibb Co. said a hepatitis C drug will lose a special designation from U.S. regulators that may have led ...
Posted by Michael Wonder on 05 Aug 2015
Novartis can sell copycat of Amgen’s Neupogen in September, court rules
Novartis AG’s Sandoz unit may begin selling the first copy of Amgen Inc.’s cancer treatment Neupogen as soon as Sept. ...
Posted by Michael Wonder on 05 Aug 2015
Technivie (ombitasvir, paritaprevir and ritonavir tablets) receives FDA approval as the first and only all-oral, interferon-free treatment for genotype 4 chronic hepatitis C in the U.S.
AbbVie, a global, research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Technivie (ombitasvir, paritaprevir and ritonavir ...
Posted by Michael Wonder on 05 Aug 2015
Eisai submits marketing approval applications for anticancer agent lenvatinib simultaneously in Europe and US
Eisai Co., Ltd. announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and ...
Posted by Michael Wonder on 05 Aug 2015
FDA rejects Avanir's migraine drug-device
The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new indication for Bayer's Kogenate
The US FDA has approved a new indication for German drug major Bayer's Kogenate FS antihemophilic factor VIII (recombinant), for ...