Remove Cardiology Remove Clinical Development Remove Medicine
article thumbnail

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development. Relative to other areas of medicine (e.g.,

article thumbnail

Vericiguat approved in Japan to treat patients with chronic heart failure

The Pharma Data

The approval is based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020. Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Bayer delivers on medical innovation fueling transformation of pharma business

The Pharma Data

We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Tackling this challenge with advanced technologies and products, radiology is a key enabler to transform healthcare, expanding personalized medicine and improving outcomes for patients.

article thumbnail

BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson’s Disease

The Pharma Data

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

Trials 52
article thumbnail

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” ” Ludwig Hantson , Ph.D., Strategic rationale.

article thumbnail

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

pharmaphorum

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for the company to proceed with its ‘ROCSTAR’ clinical trial to further test the system as a potential treatment for persistent AF.

Trials 52
article thumbnail

BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

XTalks

A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. BridgeBio is also working to address gaps in ATTR-CM diagnosis through its TRACE-AI Network Study , a collaboration with the Cardiovascular Data Science Lab (CarDS Lab) at the Yale School of Medicine.