Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Side effects 64

Side effects Food and Drug Administration Safety Physicians 64

European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. QMS market to value nearly $4b by 2030 Improving the CAPA process – what does the risk-based framework include?

Food and Drug Administration 52

Food and Drug Administration Medical Management FDA 52

European Pharmaceutical Review

MARCH 7, 2024

percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy). Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. CEO of Cardio Flow, stated: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development.

Food and Drug Administration 52

Food and Drug Administration Food FDA Physicians 52

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). In the study, Hemgenix reduced or eliminated the need for prophylactic treatment in 94% of patients. Hemgenix is the first and only gene therapy approved for haemophilia B.

Patients 98

Patients Food and Drug Administration Engineering Sales 98

European Pharmaceutical Review

SEPTEMBER 21, 2023

billion by 2030. In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. How has the gene therapy landscape evolved over the last several years?

Pharmaceutical 73

Pharmaceutical Food and Drug Administration Medicine Manufacturing 73

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. We’ve learnt that innovative therapies, like Zolgensma, require equally inventive access pathways so that as many patients as possible benefit from treatment.

Food and Drug Administration 69

Food and Drug Administration Government Healthcare Healthcare 69

Medico Reach

OCTOBER 17, 2022

from 2022 to 2030. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. The device replaces a connecting bone in the ankle joint and can be customized according to patient preference.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Medico Reach

OCTOBER 17, 2022

from 2022 to 2030. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. The device replaces a connecting bone in the ankle joint and can be customized according to patient preference.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52