Remove Patients Remove Pharmacology Remove Safety
article thumbnail

FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency

PharmExec

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

article thumbnail

MHRA Chief Executive to step down

European Pharmaceutical Review

While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.

Safety 111
Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. Specifically, it described how ERP systems clarify every aspect of operations in a business for drug serialisation compliance.

article thumbnail

Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

article thumbnail

Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 105
article thumbnail

Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.

article thumbnail

Novo Nordisk, Kry partner on digital programme for obesity

pharmaphorum

It also marks the first move by Kry beyond the primary care category, where it provides virtual GP consultation services to millions of patients across various European countries, into tools for the treatment and prevention of chronic diseases. Novo Nordisk recently predicted its obesity sales could reach $3.7 billion in 2025.