Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 27 Jan 2022
Positive Early Access to Medicines Scheme (EAMS) scientific opinion awarded to GBT’s voxelotor for the treatment of haemolytic anaemia due to sickle cell disease
27 January 2022 - Global Blood Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded ...
Posted by Michael Wonder on 27 Jan 2022
Do federal price transparency regulations neglect oncology patients?
24 January 2022 - The National Cancer Institute has identified measuring, understanding, and addressing cancer-related patient financial hardship as a top ...
Posted by Michael Wonder on 27 Jan 2022
2022 April price disclosure cycle – indicative prices
27 January 2022 - Indicative 1 April 2022 prices resulting from the 2022 April Cycle of Price Disclosure have now been ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 17 Jan 2022
TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients
18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...
Posted by Michael Wonder on 17 Jan 2022
TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia
17 January 2022 - Today, the TGA determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya ...