FDA Law Blog: Biosimilars
MARCH 18, 2025
Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.
Drug Target Review
FEBRUARY 28, 2024
from 2003 to 2006, covering the biotechnology and life-science tools sectors. Regulation of cutaneous malignancy by gammadelta T cells. J Exp Med 198(5):747-755 (2003). Previously, Mr Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co.
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Perficient: Drug Development
FEBRUARY 22, 2024
I worked on many projects with them in my early career (2003-2013). At that time, their industry was driven by government regulations and tariffs. A Real-World Personal Example – Zagging to Success A successful “zag” with a great idea doesn’t need to be risky. Atlas Van Lines is in the moving and relocation industry.
FDA Law Blog: Biosimilars
SEPTEMBER 19, 2023
It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.
Drug Target Review
MAY 18, 2023
Results of the Multicenter Study of Hydroxyurea in Sickle Cell Anaemia published in the Journal of the American Medical Association in 2003, indicated that the use of hydroxyurea, the only drug approved at the time, reduced mortality as it reduced pain crises and increased foetal haemoglobin.
The Pharma Data
JANUARY 18, 2021
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to any securities of Biophytis in any country.
The Pharma Data
APRIL 14, 2021
with Xolair since its initial approval in 2003. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. Approximately 460,000 patients have been treated in the U.S. In the U.S., About Xolair.
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