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RSS FeedPosted by Michael Wonder on 28 Oct 2021
Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show
28 October 2021 - CytoDyn and its CEO Nader Pourhassan have known the company’s long delayed HIV drug was in ...
Posted by Michael Wonder on 28 Oct 2021
COVID-19 vaccine weekly safety report (28 October 2021)
28 October 2021 - To 24 October, the TGA has received 235 reports which have been assessed as likely to be ...
Posted by Michael Wonder on 27 Oct 2021
Moderna announces Swissmedic authorises booster dose of Moderna’s COVID-19 vaccine
26 October 2021 - Authorisation granted for particularly vulnerable individuals 12 years of age and older. ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...
Posted by Michael Wonder on 27 Oct 2021
FDA, NIH and 15 private organisations join forces to increase effective gene therapies for rare diseases
27 October 2021 - The U.S. FDA, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organisations have partnered ...
Posted by Michael Wonder on 27 Oct 2021
Vertex's supplement to a new drug aubmission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 6-11 accepted for priority review by Health Canada
27 October 2021 - Vertex Pharmaceuticals today announced that its supplement to a new drug submission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
Posted 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 ...