Agency IQ

AUGUST 18, 2023

The subgroup continues to work through technical aspects of certificates, clinical trial and performance study applications, vigilance and trending reports and market surveillance. We’ve seen what’s been going on with the MDR, but the main concern we’ve heard of IVDR is the performance study application process is affecting drug trials.

Science 40

Science Regulations Laboratories Production 40

Agency IQ

FEBRUARY 21, 2024

In sum, the aim of the organization and its stakeholders is to develop an online environment to house everything from clinical trial data to marketing applications, to product labeling, manufacturing changes, and more. The top request to TGA from stakeholders was for increased international harmonization and cooperation.

Science 40

Science Regulations International FDA 40

Agency IQ

AUGUST 2, 2024

For example, on July 25, the Hungarian presidency hosted an informal meeting of health ministers to discuss health issues, such as mitigating the effect of cardiovascular diseases and implementing the European Health Data Space (EHDS).

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

FDA 40

FDA Science Biosimilars Regulations 40

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0%

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

DECEMBER 30, 2020

This week, Bloomberg reported companies agreed to slash the prices of 119 new therapies that treat a range of illnesses, including pulmonary disease, lupus, diabetes and cancer. billion by 2027. Belarus was also the first foreign country to begin clinical trials of Sputnik V. Most Read Today. Source link.

Immune Response 52

Immune Response Vaccine Clinical Trials Treatment 52

Codon

OCTOBER 6, 2024

Results such as these have been so encouraging that in September of last year, the FDA began to review the idea of moving to human trials. Indeed, the stakes in the first real-world use of artificial wombs may be higher than in almost any clinical trial imaginable. ” Others have much more ambitious plans for the next five years.

FDA 117

FDA Hospitals Engineering Research 117

Drug Target Review

MARCH 20, 2025

Its one of the most common heart rhythm disorders and can be caused by conditions like high blood pressure and heart disease, or can sometimes occur without an obvious cause. The safety data from the AZALEA trial suggest that abelacimab has a remarkably lower rate of bleeding compared to rivaroxaban, which directly addresses this fear.”

Therapies 52

Therapies Trials Clinical Development FDA 52

The Pharma Data

MAY 4, 2021

Rare Disease. RE47,739 for Ibrance by more than four years until March 2027. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. The vaccine was 100% effective against severe disease as defined by the U.S. Internal Medicine.

Vaccine 40

Vaccine Production FDA Clinical Trials 40