Camargo
AUGUST 11, 2021
The FDA oversees all drug approvals in the US via New Drug Applications (NDAs), with approvals for biologic products being approved via Biologics License Applications (BLAs). Meeting Package Due. To address a stalled product development plan or an important safety issue. Meeting Type. Meeting Purpose. Meeting Timing 1.
The Pharma Data
NOVEMBER 18, 2021
Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.
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The Pharma Data
MARCH 29, 2022
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.
The Pharma Data
DECEMBER 8, 2020
Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.
Drug Discovery World
MARCH 29, 2023
Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.
The Pharma Data
APRIL 27, 2021
For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions.
The Pharma Data
JANUARY 13, 2021
.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.
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