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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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COVID-19 vaccines and treatments: we must have raw data, now

19 January 2022 - Data should be fully and immediately available for public scrutiny ...

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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.  ...

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TGA in review (2021)

19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...

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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 ...

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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 ...

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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 ...

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