Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” Additionally, Co-chief Operating Officer, Marie-Hélène Raigneau, said of the study: “Our goal at Altasciences is to help companies like Ischemix expedite the drug development process without compromising on quality or safety.

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Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

Clinical Trials 52

Clinical Trials Trials Drugs Drug Development 52