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RSS FeedPosted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted by Michael Wonder on 16 Feb 2021
Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)
15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...
Posted by Michael Wonder on 16 Feb 2021
TGA provisionally approves AstraZeneca's COVID-19 vaccine
16 February 2021 - The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...
Posted by Michael Wonder on 15 Feb 2021
TGA approves new formulation of glatiramer acetate
16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity. ...
Posted by Michael Wonder on 15 Feb 2021
Targovax receives fast track designation for ONCOS-102
15 February 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in malignant ...
Posted by Michael Wonder on 15 Feb 2021
One billion dollar bid to go it alone with COVID-19 vaccine hub
15 February 2021 - A proposal for a state-of-the-art $1 billion facility to manufacture vaccines and prescription drugs in Australia ...
Posted by Michael Wonder on 15 Feb 2021
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of Krabbe disease with PLX-300
10 February 2021 - Polaryx Therapeutics announced today that it has received both rare paediatric disease and orphan drug designations for ...
Posted by Michael Wonder on 15 Feb 2021
Pay for plasma collection coming to Alberta by end of the year
14 February 2021 - Repeal of NDP bill last fall clears way for Canadian Plasma Resources to set up shop. ...
Posted by Michael Wonder on 15 Feb 2021
It’s time to fast track innovation in medical devices for children
11 February 2021 - When a baby arrived at Children’s National Hospital with a critically underdeveloped heart, it was clear ...
Posted by Michael Wonder on 15 Feb 2021
Xeris Pharmaceuticals receives European Commission approval of Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus
12 February 2021 - Ogluo Europe’s first and only ready-to-use liquid glucagon for rescue. ...
Posted by Michael Wonder on 14 Feb 2021
European Commission approves Seagen’s Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
12 February 2021 - Approved for adult patients with HER2 positive metastatic breast cancer who have received at least two prior ...
Posted by Michael Wonder on 14 Feb 2021
Assessment of FDA and EMA approved systemic oncology therapies and clinically meaningful improvements in quality of life
11 February 2021 - Are oncology therapies recently approved by the US FDA and the EMA associated with clinically meaningful improvements ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
Posted by Michael Wonder on 14 Feb 2021
FDA approves drug to reduce bone marrow suppression caused by chemotherapy
12 February 2021 - Today, the U.S. FDA approved Cosela (trilaciclib) as the first therapy in its class to reduce the ...