Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
The US Food and Drug Administration (FDA) has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.
Samsung Biologics has introduced two new platforms focused on optimized antibody production and systematic screening of molecules at an early development stage.
A push toward multimodal businesses is encouraging greater reliance on contract development and manufacturing organizations (CDMOs), finds a new report.
Vitamin D supplementation does not influence the efficacy or immunogenicity of SARS-CoV-2 vaccinations in patients with sub-optimal levels prior to vitamin treatment, according to a new study.
VBI Vaccines has started enrollment in a Phase 1 clinical study of VBI-2901, a multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate targeting SARS, COVID-19 and MERS.
Penn spinout, Verismo Therapeutics, says the FDA has granted Orphan Drug Designation (ODD) to its KIR-CAR T-cell immunotherapy drug, SynKIR-110, for the treatment of patients with mesothelin-expressing mesotheliomas.
An investigational Alzheimer's drug made by Eisai Co Ltd and Biogen slowed cognitive and functional decline in a trial involving a large group of patients in the early stages of the disease.
Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, NK-001.
iBio is jockeying for position as a leading player in AI-powered drug discovery while also expanding its immuno-oncology pipeline after closing on the acquisition of multiple assets from its partner, RubrYc Therapeutics.
Fujifilm Diosynth Biotechnologies (FDB) said the expansion of its large-scale microbial manufacturing facility at the Billingham campus in the north-east of England, has got underway.
The US National Institutes of Health plans to invest $130m in accelerating the widespread use of artificial intelligence (AI) by the biomedical and behavioral research communities through its Bridge2AI program.
The US regulator has given the green light for the distribution of doses of Moderna's COVID-19 booster shots from a manufacturing plant in Indiana run by Catalent.
San Francisco based Cellares is partnering with Lexington, Massachusetts headquartered iVexSol to accelerate and improve the quality of viral vector manufacturing and transduction.
An extension of a Phase 3 trial for Biogen’s tofersen shows benefits in a form of motor neuron disease, according to a study published in the New England Journal of Medicine (NEJM) this week.
Almost all of Australia’s vaccines are imported: creating a potential crisis in a pandemic. As a result, the country is setting out its strategy for developing vaccine manufacturing capabilities.
Vaxxas will receive an AU$8.2m second round grant to support the manufacturing scale-up of its technology that enables vaccines to be applied to the skin using a small patch.
The EU’s tailor-made centralised system for vaccine procurement was successful in procuring sufficient doses of COVID-19 vaccines, but a new report finds holes in the approach.
Rocket Pharmaceuticals, a late-stage, clinical biotech advancing a pipeline of genetic therapies for rare childhood disorders, will acquire Renovacor: helping it strengthen its position in AAV-based cardiac gene therapy.
A new pilot training model, one using augmented reality (AR) and virtual reality (VR) to support learning, is aimed at individuals looking to boost their knowledge and skills so they can continue to progress the area of Advanced Therapy Medicinal Product...
Ncardia’s cell therapy development and manufacturing business Cellistic will acquire Celyad Oncology’s GMP grade cell therapy manufacturing capability, covering Celyad’s Mont-Saint-Guibert facility in Belgium and all related staff.
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
Pfizer will submit a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine (MenABCWY) to the US Food and Drug Administration (FDA) later this year, following positive top-line results from a Phase 3 trial.
Novo Nordisk and Microsoft have entered a new strategic collaboration to combine Microsoft’s computational services, cloud, and artificial intelligence (AI) with Novo Nordisk’s drug discovery, development, and data science capabilities.
Ori Biotech (Ori) and the Cell Therapy Manufacturing Center (CTMC) have announced a collaborative partnership to develop industrial manufacturing processes for cell therapies.
Orca Bio, a biotech developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, will expand its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial...
UK-based biopharmaceutical company, PhoreMost, is to deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER, toward disease-relevant pathways nominated by Roche.
What role does Bioprocessing 4.0 have to play in the ongoing energy crisis? How can we train and develop the right skills for the industry? These are just some of the questions we’ll ask in our free-to-attend webinar tomorrow!
A Series A financing round, led by Deerfield Management, is aimed at accelerating a new cell therapy modality for the treatment of neurological disorders, including Parkinson’s Disease.
A US federal judge ruling that a Californian clinic’s stromal vascular stem cell treatments do not fall under the FDA's regulatory jurisdiction is of significant concern, says the ISCT.
Experts from the health information specialist explain how the use of RWD and RWE has helped speed up and improve the development of therapies and vaccines.
A collaboration between Touchlight and Lonza expands the Swiss CDMO’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material, the UK biotech’s doggybone DNA (dbDNA).
Technology firm, Benchling, has developed what it calls the biopharma industry’s first set of full capabilities for designing, modelling, and studying both natural and chemically modified RNA in a single platform.
