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With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
The manufacturing capacity for some of Boehringer Ingelheim’s medicines, in disease areas including mental health and cardio-renal-metabolic conditions, will benefit from the European facility expansion.
With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.
Novartis has obtained US manufacturing authorisation for radioligand therapy PluvictoTM at its largest, state-of-the-art radioligand therapy facility.
While constraints such as inflation and drug pricing pressures will impact pharma’s growth in 2024, patent expiration of biologics is expected to support the industry over the next few years, research suggests.
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.
The new industry collaboration aims to help decarbonise the global supply chain by focusing on the energy-intensive pharmaceutical manufacturing that takes place in China and India.
