European Pharmaceutical Review
FEBRUARY 27, 2024
While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.
Legacy MEDSearch
AUGUST 25, 2022
The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020.
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European Pharmaceutical Review
MAY 2, 2023
In 2019, the pharmaceutical industry spent $83 billion on R&D, which is about 10 times what the industry spent per year in the 1980s, 4 yet the average duration to develop a new medicine is still around 10-15 years. About the authors Dr Nils Eckardt joined BeiGene in February 2019 as Vice President, Medical Affairs, Europe.
European Pharmaceutical Review
MARCH 11, 2024
About the author Sherene Min, MD, MPH, is Vice President of Global Clinical Development at ViiV Healthcare , a role she assumed in October 2019. With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety.
European Pharmaceutical Review
DECEMBER 11, 2023
mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.
European Pharmaceutical Review
SEPTEMBER 22, 2023
7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile. While favourable safety has been reported up to the Phase II, the relevance of targeting the C-terminal portion of Abeta still needs to be confirmed.
Pharmaceutical Technology
FEBRUARY 8, 2023
Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. Blank acknowledged that in many cases, an exclusively paediatric patient population could lead to difficulties with drawing consent for early phase trials.
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