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RSS FeedPosted by Michael Wonder on 27 Oct 2021
TGA approval for Pfizer COVID-19 vaccine booster dose
27 October 2021 - The TGA has approved a booster dose of the Pfizer COVID-19 vaccine for individuals 18 years ...
Posted by Michael Wonder on 27 Oct 2021
Democratic senators raise concerns with potential FDA pick
26 October 2021 - Sens. Joe Manchin and Richard Blumenthal have concerns with President Biden’s rumoured nominee for the FDA, ...
Posted by Michael Wonder on 27 Oct 2021
TGA approves booster doses of the Pfizer COVID-19 vaccine Comirnaty
27 October 2021 - The TGA has provisionally approved a booster dose of the Pfizer COVID-19 vaccine, Comirnaty, for individuals ...
Posted by Michael Wonder on 26 Oct 2021
Strengthening the reporting of observational studies in epidemiology using Mendelian randomisation: the STROBE-MR Statement
26 October 2021 - An international expert committee, informed by the methodological framework for guideline development of the Enhancing the Quality ...
Posted by Michael Wonder on 26 Oct 2021
Lilly pipeline success strengthens future growth potential
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
Posted by Michael Wonder on 26 Oct 2021
Eyenovia announces reclassification of MydCombi as drug device combination product by FDA
25 October 2021 - Company received complete response letter with additional requests and is preparing necessary documents for expedited resubmission, ...
Posted by Michael Wonder on 26 Oct 2021
Bausch + Lomb and Clearside Biomedical announce FDA approval of Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular oedema Associated with Uveitis
25 October 2021 - Xipere is the first and only medicine to be approved in the United States for delivery ...
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 ...
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) ...
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 ...
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 ...
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. ...
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), ...
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 ...
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 ...