Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.
PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
Pfizer has said it will stop working on bococizumab and cease late phase trials of the monoclonal antibody (mAb) cholesterol buster being run by Ireland-based CRO, Icon.
Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.
Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
TxCell is working on new ways of delivering its Crohn's disease therapy Ovasave that will replace the somewhat unusual method it is using in clinical trials.
WuXi Biologics and Prima BioMed have announced that the first dose of a Chinese-manufactured biologic has been dosed in a clinical trial in the European Union.
Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.
While data extrapolation is acceptable in approving US biosimilars across the same indications as its reference, the practice will not be applicable for the next generation of copycat biologics, a biotech expert says.
US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.
ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.
TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.
Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.
Takeda is closing three US R&D facilities and relocating its global HQ to a site in Massachusetts as part of plans to consolidate its vaccine business.
With the release of three final guidance documents on biosimilars, the FDA is offering more clarity for developers seeking to fine-tune their understanding of the science and quality of biosimilars.
Merck has agreed to research, develop, manufacture, and distribute NewLink’s investigational Ebola vaccine candidate, which is currently in Phase I trials.
Collaboration does not mean drugmakers have started playing nice, it’s just that the pain of shared problems has become unbearable according to TransCelerate Biopharma CEO, Dalvir Gill.
Specialty vaccine company PaxVax has acquired the oral typhoid vaccine Vivotif from Crucell, as well as its manufacturing facility in Thörishaus, Switzerland. Financial terms of the transaction were not disclosed.
Swiss-based Mymetics has agreed with Australian biotech Imugene to manufacture and develop its cancer immunotherapy HER-Vaxx, which is expected to enter into a Phase I/II clinical trial in 2015.
Oncology development company Celsion will acquire Egen, a biotech company that is developing nucleic acid-based therapeutics, for $14m upfront, with the chance for more than $30m in milestone payments.
The US Food and Drug Administration (FDA) has approved a second “Breakthrough Therapy” biologic but it is still unclear whether the programme speeds drugs to market, says an expert.
Cell therapy developer NeoStem has agreed to acquire California Stem Cell in a deal worth up to $124M, and includes CSC’s manufacturing facility in Irvine, CA.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers....
