Remove Compliance Remove Containment Remove In-Vivo
article thumbnail

In the News: October Regulatory and Development Updates

Camargo

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.

article thumbnail

Federal Court finds a combination therapy patent valid and infringed

Pharma in Brief

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). OPSUMIT® is a tablet containing macitentan. Background. Janssen Inc. Janssen Inc. Sandoz Canada Inc. Sandoz ) sought approval for a generic macitentan product.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Advancements In Automation Of Manufacturing Processes: Key Value Driver For Escalated Interest In The Cell Therapy Domain

Roots Analysis

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.

article thumbnail

Quantitative Neuroimaging of Alzheimer’s Disease

WCG Clinical

In the appropriate clinical setting, when this observation is considered, further evaluation with a quantitative CSF flow study can document elevation of aqueductal CSF stroke volume associated with decreased periaqueductal white matter compliance. Data from the Alzheimer’s Association estimates that approximately 5.4

article thumbnail

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% to €1,047 million) and oncology launches. General Medicines core assets grew 4.4%, while GBU sales were down 3.8%.

Sales 52