Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.
Camargo
DECEMBER 22, 2021
For products that have an US RLD counterpart, FDA may waive in vivo study requirements, depending on the drug formulation, proposed indication, active ingredients, solubility, permeability, and other factors. These are put in place to ensure product quality in compliance with FDA requirements. Clinical Pharmacology.
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Pharma in Brief
JUNE 14, 2022
The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure. Background.
The Pharma Data
NOVEMBER 15, 2020
. Positive one-year results from the STAR-II European trial sustain the remarkable six-month outcomes and are consistent with the STAR-I trial results at one year. Promising MINIject data at two years from the STAR-I trial were recently published in the British Journal of Ophthalmology. medications at baseline).
Pharma in Brief
FEBRUARY 3, 2021
The Court’s decision concerned the claims of two patents asserted against each of the Defendants in infringement actions under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ): Canadian Patent No. Background. ELIQUIS TM (an blood thinner) is marketed in Canada by Bristol-Myers Squibb Canada Co. Pharmascience Inc.
Roots Analysis
SEPTEMBER 20, 2023
Cell therapies are based on the premise that the patient’s own cells ( autologous ), or those from a healthy donor ( allogeneic ), can be genetically re-programmed to combat various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit.
Roots Analysis
SEPTEMBER 13, 2023
The synergistic behavior achieved from the process circumvents the inherent limitation of the individual counterparts, such as short in vivo half-life, low solubility and immunogenicity. It consists of somatostatin-derived peptide and DOTA complexed with radioactive isotope 77 Lu.
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