Blog
RSS FeedPosted by Michael Wonder on 10 Sep 2020
‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA
10 September 2020 - How can Americans tell when the FDA has become so politically impaired that it cannot serve ...
Posted by Michael Wonder on 10 Sep 2020
Halozyme announces Janssen submission for FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of patients with light chain amyloidosis
10 September 2020 - Follows FDA approval of Darzalex Faspro utilising Enhanze technology in May 2020 for the treatment of patients ...
Posted by Michael Wonder on 10 Sep 2020
Vaccine developers hustle to meet FDA data requirements to submit for approval
10 September 2020 - There are many questions regarding the approval of a potential COVID-19 vaccine. ...
Posted by Michael Wonder on 10 Sep 2020
EU review extended for BioMarin's gene therapy Valrox
10 September 2020 - European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene ...
Posted by Michael Wonder on 10 Sep 2020
FDA approves Trelegy Ellipta as the first once daily single inhaler triple therapy for the treatment of both asthma and COPD in the US
9 September 2020 - New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment ...
Posted by Michael Wonder on 10 Sep 2020
Some good news on COVID-19
9 September 2020 - The virus seems to generate a robust and fairly long-lasting immune response. ...
Posted by Michael Wonder on 10 Sep 2020
BeiGene announces acceptance and priority review by Health Canada of new drug submission for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
9 September 2020 - BeiGene today announced that its new drug submission for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted 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 ...