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RSS FeedPosted by Michael Wonder on 09 Sep 2020
‘You can’t rush science’ — Merck CEO stresses need for careful approach to coronavirus vaccine
9 September 2020 - Frazier’s Merck was among the nine companies that signed a pledge to prioritise safety as the drugmakers ...
Posted by Michael Wonder on 09 Sep 2020
Clarity Pharmaceuticals announces the US FDA grants rare paediatric disease designation to 64 Cu sartate, a diagnostic for the clinical management of neuroblastoma
9 September 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 09 Sep 2020
Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause
9 September 2020 - As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, ...
Posted by Michael Wonder on 09 Sep 2020
TGA approves yet another flu vaccine
9 September 2020 - As its brand name suggests, Flucelvax Quad is a new quadrivalent influenza vaccine. ...
Posted by Michael Wonder on 09 Sep 2020
COVID-19 vaccine development
9 September 2020 - Australia’s COVID-19 Vaccine and Treatment Strategy supports early access to, and delivery of, safe and effective COVID-19 ...
Posted by Michael Wonder on 09 Sep 2020
Ascendis Pharma submits marketing authorisation application to the EMA for TransCon hGH for the treatment of paediatric growth hormone deficiency
8 September 2020 - Ascendis Pharma announced today the submission of a marketing authorisation application to the EMA seeking approval for ...
Posted by Michael Wonder on 08 Sep 2020
BeyondSpring receives breakthrough therapy designations from both U.S. FDA and China NMPA for plinabulin in chemotherapy-induced neutropenia indication
8 September 2020 - Among the first three innovative drugs to receive breakthrough therapy designations in China. ...
Posted by Michael Wonder on 08 Sep 2020
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - New breakthrough device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK ...
Posted by Michael Wonder on 08 Sep 2020
Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
Posted by Michael Wonder on 08 Sep 2020
U.S. FDA approves Athena Bioscience's new drug application for Qdolo (tramadol hydrochloride) oral solution
8 September 2020 - FDA approved Qdolo (tramadol hydrochloride), an oral liquid, accommodates dosing flexibility, precise titration. ...
Posted by Michael Wonder on 08 Sep 2020
FDA approves first NGS-based companion diagnostic for RET fusion positive non-small cell lung cancer
8 September 2020 - CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for Gavreto. ...
Posted by Michael Wonder on 08 Sep 2020
FDA sets up vaccine safeguards to counter pressure from Trump
8 September 2020 - Guidelines for emergency approval designed to insulate reviewers from influence. ...
Posted by Michael Wonder on 08 Sep 2020
Biopharma leaders unite to stand with science
8 September 2020 - Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the ...
Posted by Michael Wonder on 08 Sep 2020
RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.
7 September 2020 - RadioMedix and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved ...
Posted by Michael Wonder on 08 Sep 2020
Janssen announces European Commission decision for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
7 September 2020 - Patients who were new to chronic lymphocytic leukaemia treatment lived longer without disease progression with the Imbruvica ...