MAESTrO: Blog

Feature Posted by Michael Wonder on 31 Aug 2025

FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Posted by Michael Wonder on 26 Oct 2021

Generating high quality evidence from registry based studies

26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on ...

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Posted by Michael Wonder on 26 Oct 2021

The challenges of inadequate financial support for Australians with cancer

21 October 2021 - The publicly funded Medicare system in Australia has been recognised as a leading universal health care model. ...

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Posted by Michael Wonder on 25 Oct 2021

Spikevax: EMA recommendation on booster

25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...

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Posted by Michael Wonder on 25 Oct 2021

Merck and Ridgeback announce initiation of a rolling review by the European Medicines Agency for molnupiravir, an investigational oral anti-viral medicine, for the treatment of COVID-19 in adults

25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...

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Posted by Michael Wonder on 25 Oct 2021

The risks of government negotiation of drug prices

25 October 2021 - Under the guise of Medicare ‘negotiations,’ the US House of Representatives is considering a measure that would ...

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Posted by Michael Wonder on 25 Oct 2021

Drug pricing reform opponents win most pharma lobbying money

26 October 2021 - Democratic Party law makers holding up proposed drug pricing reforms are among the largest beneficiaries of the ...

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Posted by Michael Wonder on 25 Oct 2021

Roche’s Ventana PD-L1 (SP263) assay receives FDA approval as a companion diagnostic to identify certain non-small-cell lung cancer patients eligible for Tecentriq (atezolizumab)

22 October 2021 - The Ventana PD-L1 (SP263) assay helps determine which non-small-cell lung cancer patients may benefit from treatment with ...

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Posted by Michael Wonder on 25 Oct 2021

Alkermes receives FDA fast track designation for nemvaleukin alfa in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer

26 October 2021 - Second fast track designation for nemvaleukin. ...

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Posted by Michael Wonder on 25 Oct 2021

COVID-19: EMA starts rolling review of molnupiravir

25 October 2021 - EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (MK 4482; Lagevrio), ...

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Posted by Michael Wonder on 25 Oct 2021

Biden speaks with potential FDA commissioner

25 October 2021 - President Joe Biden recently held a call with Dr. Rob Califf, the former FDA commissioner, who ...

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Posted by Michael Wonder on 25 Oct 2021

European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer

22 October 2021 - Keytruda is now approved in combination with chemotherapy as first-line treatment for patients with locally recurrent unresectable ...

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