Biopharma News

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

Catalent plans to add cryogenic capabilities to its facility in Philadelphia, which will strengthen its ability to cryogenically preserve cell therapies and other biological materials.

Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture cGMP material for the mAb while supporting the process from gene to IND.

Sterling Pharma Solutions has acquired ADC Biotechnology, a bioconjugation development services business specializing in antibody drug conjugates.

The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

BIA and Clarivate have released data showing that UK biotech companies are set to experience another strong year for fundraising in 2021.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Growth in cell and gene therapies puts pressure on the raw materials supply chain.

The companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process.

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

Sana will be authorized to use the iPSC cell lines from FUJIFILM Cellular Dynamics for the research and development, clinical and commercial manufacture, and commercialization, of the cell therapies derived from the lines.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.