Biopharmaceutical Manufacturing, Upstream, Downstream …
Jan 23, 2025 · News on the biopharmaceutical manufacturing industry, focusing on biologics, technology, upstream/downstream processing, cell culture and regulations
FDA approves first mesenchymal stromal cell therapy
Dec 19, 2024 · Ryoncil (remestemcel-L-rknd) has been granted approval by the FDA for the treatment of steroid-refractory acute graft-versus-host-disease (SR-aGVHD) in pediatric patients 2 months of age and older. This decision makes Ryoncil the first mesenchymal stromal cell (MSC) therapy to ever receive FDA approval. Developed by Australian cell therapy specialist Mesoblast, Ryoncil is an allogeneic therapy ...
CN Bio raises $21 million to scale up organ-on-a-chip technology
Apr 23, 2024 · CN Bio has raised $21 million in Series B financing to meet increasing demand for its organ-on-a-chip (OOC) solutions.
FDA approves first-ever gene therapy to be directly administered …
Nov 19, 2024 · The FDA has granted accelerated approval to Kebilidi (eladocagene exuparvovec-tneq) as a treatment for children and adults with AADC deficiency, including the full spectrum of disease severity. This approval makes Kebilidi the first therapy that is directly administered to the brain to ever gain approval in the US. AADC deficiency is caused by mutations of the gene that encodes for the ...
Biosimilars overview: Formycon assesses the space
Nov 20, 2024 · Stefan Glombitza has over 28 years of experience in the pharmaceutical business, having long worked in the generics space before joining Formycon as Chief Operating Officer in 2016 and being appointed CEO in 2022. Now, the Munich-based company’s first biosimilar is available in 20 countries, and two more of its products have been approved in the biosimilars space this year. Formycon is now ...
Ottimo Pharma emerges from stealth mode with promising cancer …
Oct 29, 2024 · UK-based private biotech company Ottimo Pharma has emerged from stealth mode after four years with the appointment of a strong leadership team. David Epstein is joining the company as the new Chair and CEO. Epstein is the former CEO of Seagen, which was sold to Pfizer for $43 billion last year. Former SVP and Chief Medical Officer at Boehringer Ingelheim, Mehdi Shahidi, is joining Ottimo ...
How will the Biosecure Act impact the pharma industry?
Oct 8, 2024 · But what does the Act mean for the biotech and pharma industry and how can companies best prepare for any impacts on future business? The Biosecure Act was first proposed by the US government late last year due to concerns about national security and how genetic and other biological data could be misused by foreign adversarial governments with a focus on China. It intends to prevent US federal ...
FDA approves Astellas’ Vyloy cancer drug & Roche diagnostic test
Oct 22, 2024 · The FDA has simultaneously granted approval to Astellas’ cancer drug Vyloy and to a companion diagnostic test developed by Roche.
Amgen: Phase 2 results for GLP-1-GIP weight loss drug
Nov 28, 2024 · MariTide is being studied for the treatment of obesity and Type 2 diabetes and demonstrated weight loss at 52 weeks.
Aditum Bio and Leads Biolabs join forces to fight autoimmune …
Nov 7, 2024 · The U.S. company Aditum Bio and Chinese company Leads Biolabs today announced that they have founded Oblenio Bio, a new company that will develop a potentially first-in-class tri-specific T cell engager for the treatment of difficult-to-treat autoimmune diseases. The drug named LBL-051 is a CD19xBCMAxCD3-targeting antibody, designed to activate T cells that can then deplete overreactive B ...