PharmTech Europe News

New plans laid out by AstraZeneca will see £650 million ($828 million) be invested into the UK.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

Wider life sciences industries in the UK and Europe are receiving favourable financial support from governing bodies.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

ProductLife Group has announced its acquisition of Australian company Commercial Eyes.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

Agilent Technologies and Incyte have signed an agreement to collaborate on the development of companion diagnostics programs.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

IMU Biosciences has secured £11.5 million in its Series A financing round.

Getinge has announced the inauguration of its new Global Centre of Excellence for Chemistry in the United Kingdom

The annual industry report of the Pharmapack Europe event suggests there will be significant innovation in inhaled pulmonary and intranasal drug delivery in 2024.

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

According to the Pharmapack Europe 2024 survey results, contract packaging will see growth over the coming 12 months.

CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.