pharmaphorum

DECEMBER 22, 2022

If approved, etrasimod will mount a direct challenge to Bristol-Myers Squibb’s S1P drug Zeposia (ozanimod), which was approved for UC last year and also for a green light to treat multiple sclerosis in 2020. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy.”

Pharmacology 52

Pharmacology Safety Patients Marketing 52

pharmaphorum

DECEMBER 20, 2022

That’s impressive, as it has proved exceedingly difficult for pharmacological therapies to show an impact on fibrosis in prior studies. Similarly, a one-stage or greater improvement in liver fibrosis was seen in 24% and 26% of the resmetirom groups, respectively, versus 14% of patients taking placebo.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

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.

Medical 52

Medical FDA Recruitment Pharmacology 52

European Pharmaceutical Review

MAY 2, 2023

By collaborating with several stakeholders and authorities, multiple stages of development can take place concurrently to speed up R&D without compromising safety protocols. Dr Mieke Borgs has been Head of Clinical Operations Europe at BeiGene since May 2020. The COVID-19 blueprint has shown a way forward.

Patients 99

Patients Medicine Marketing Medical 99

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.

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105