PharmTech Europe News

GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

CordenPharma has partnered with Spain-based Certest to develop ionizable lipids for LNP formulations.

The completed expansion at AGC Biologics'Copenhagen, Denmark, site, doubles the company's single-use bioreactor capacity for mammalian-based services.

The political landscapes of both the EU and UK are set to change after the latest elections, which could affect the bio/pharma industry.

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

CGT Catapult will implement Cellular Origins' robotic platform in its Stevenage, UK, site to establish automated CGT manufacturing.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1.

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

With the launch of a new manufacturing service, Memel Biotech will offer services for discovery through to formulation for advance therapy medicinal products.

In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.

Our Future Health, a health research program in the UK, has welcomed Novartis as a new industry partner.

Plans to update the European Union’s variation framework have been finalized.

The European pharma industry needs to be prepared for the new clinical data requirements.

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.

More synthetic opioids have been placed under the strictest controls in the United Kingdom.

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection

The European company has seen its business increase by 47% in North America.

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.