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RSS FeedPosted by Michael Wonder on 29 Sep 2020
FDA chief stands by vaccine approval criteria despite Trump pressure
29 September 2020 - The FDA, under commissioner Stephen Hahn, is in the middle of one of the most highly charged ...
Posted by Michael Wonder on 29 Sep 2020
Pfizer CEO on the pressures of creating a COVID-19 vaccine: ‘what is at stake is beyond imagination'
30 September 2020 - Albert Bourla, 58, is chairman and chief executive of Pfizer, a multinational pharmaceutical company. Bourla is a ...
Posted by Michael Wonder on 29 Sep 2020
BridgeBio Pharma and affiliate Origin Biosciences announces FDA acceptance of its new drug application for fosdenopterin for the treatment of MoCD type A
29 September 2020 - Application accepted under priority review designation with breakthrough therapy designation and rare paediatric disease designation previously granted. ...
Posted by Michael Wonder on 29 Sep 2020
Increase transparency at the FDA: we need sunlight to fight the pandemic
29 September 2020 - The FDA has issued a number of contentious decisions during the COVID-19 pandemic related to investigational ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...
Posted by Michael Wonder on 29 Sep 2020
Shionogi announces FDA approval of Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
29 September 2020 - Shionogi today announces that the U.S. FDA has approved a supplemental new drug application for Fetroja ...
Posted by Michael Wonder on 29 Sep 2020
U.S. FDA approves Pfizer's Xeljanz (tofacitinib) for the treatment of active polyarticular course juvenile idiopathic arthritis
28 September 2020 - Pfizer announced today that the U.S. FDA approved Xeljanz (tofacitinib) for the treatment of children and adolescents ...
Posted by Michael Wonder on 28 Sep 2020
Orchard Therapeutics receives EMA PRIME designation for OTL-203 for the treatment of MPS-I
28 September 2020 - Orchard Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-203, an investigational ...
Posted by Michael Wonder on 28 Sep 2020
Maritime union rejects claims medical supplies and food are being held up in pay dispute
29 September 2020 - There are fears container ships stuck off the Sydney coast could result in major delays to ...
Posted by Michael Wonder on 28 Sep 2020
Worst-rank score methods—a non-parametric approach to informatively missing data
28 September 2020 - A previous JAMA Guide to Statistics and Methods article briefly reviewed non-parametric statistics. ...
Posted by Michael Wonder on 28 Sep 2020
U.S. FDA approves Haegarda (C1 esterase inhibitor subcutaneous [human]) for prevention of hereditary angioedema attacks in paediatric patients
28 September 2020 - Haegarda is the first and only subcutaneous prophylactic hereditary angioedema treatment approved for children 6 years of ...
Posted by Michael Wonder on 28 Sep 2020
AbbVie receives orphan drug and fast track designations from the U.S. FDA for elezanumab, an investigational monoclonal antibody RGMa inhibitor, for the treatment of spinal cord injury
28 September 2020 - Elezanumab (ABT-555) is an investigational treatment being evaluated in neurological disorders, including treatment following spinal cord injury. ...
Posted by Michael Wonder on 28 Sep 2020
Khondrion receives rare paediatric disease designation for sonlicromanol from US FDA
28 September 2020 - Designation granted for the treatment of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) syndrome. ...
Posted by Michael Wonder on 28 Sep 2020
Trump seeks boost from seniors with $200 drug discount coupons
27 September 2020 - President Trump is throwing a pre-election curveball aimed at seniors with a surprise announcement on Thursday ...
Posted by Michael Wonder on 28 Sep 2020
Blueprint Medicines announces European Commission approval of Ayvakyt (avapritinib) for the treatment of adults with unresectable or metastatic PDGFRA D842V mutant gastro-intestinal stromal tumours
25 September 2020 - First highly effective treatment option approved in Europe for PDGFRA D842V mutant GIST. ...