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RSS FeedPosted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted by Michael Wonder on 11 May 2021
BMS withdraws application for Opdivo/Yervoy combination
11 May 2021 - Details revealed in new AusPAR. ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...
Posted by Michael Wonder on 10 May 2021
Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL
10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...
Posted by Michael Wonder on 10 May 2021
Amgen announces tezepelumab biologics license application submitted to U.S. FDA
10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine. ...
Posted by Michael Wonder on 10 May 2021
Positive CHMP opinion for self-administered Crysvita
10 May 2021 - The EMA's CHMP has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the ...
Posted by Michael Wonder on 10 May 2021
America wants to waive patent protection for vaccines
8 May 2021 - But it will not have an immediate effect on supplies. ...
Posted by Michael Wonder on 09 May 2021
‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...
Posted by Michael Wonder on 09 May 2021
US wary of boosting China biotech with COVID vaccine patent waiver
9 May 2021 - The Biden administration is examining ways to ensure that a waiver of COVID-19 vaccine patents to ...
Posted by Michael Wonder on 08 May 2021
AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application
7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which ...
Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 06 May 2021
The difference between an interchangeable biosimilar and one that isn't
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...