Touchlight has secured a grant from the Bill & Melinda Gates Foundation for a research program aimed at demonstrating that its enzymatically produced novel DNA format can support a rapid, scalable, durable, and thermostable vaccine solution for future...
Yposkesi, an SK pharmteco company, has been witnessing a marked uptick in cell and gene therapy projects and has learnt to effectively manage challenges within the supply chain.
The Centre for Advanced Therapies Manufacturing Training, which is based at the University of Birmingham in the UK, today announced a program aimed at growing the industry’s skills base for advanced cell and gene therapy manufacturing.
Enhancing the skills of employees working in the UK’s advanced therapy medicinal products (ATMP) sector and the broader cell and gene therapy industry is mission critical for the CGT Catapult.
Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate....
Bavarian Nordic has signed a joint procurement agreement with HERA, the European Commission’s Health Emergency Preparedness and Response Authority, for the supply of up to 2 million doses of the Imvanex (Jynneos) monkeypox vaccine during 2023 and 2024.
Corbus says new data shows its monoclonal antibody demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy.
Orgenesis, the biotech specializing in cell and gene therapy (CGT) at the point of care, and private equity firm, Metalmark, have signed a major investment partnership.
GSK’s Blenrep has proved unsuccessful in a Phase III study in multiple myeloma. The news comes two years after the drug received US Food and Drug Administration (FDA) accelerated approval.
The model for COVID-19 vaccines will undoubtedly change next year: but what this will look like in terms of key metrics such as number of doses and revenues remains in question.
AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the EU the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
The US Food and Drug Administration (FDA) has granted Priority Review to GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.
Shares of Catalent Inc plunged yesterday after the contract development and manufacturing organization (CDMO) reported fiscal first-quarter profit and revenue that missed expectations. The company also scaled back its full-year outlook.
Addition, Talis Capital, and Speedinvest were among the investors participating in the round. Seqera Labs had previously secured €4.4m (US$4.3m) in seed funding, plus grants from the Chan Zuckerberg Initiative.
As the US government stops buying COVID-19 shots, Pfizer said the vaccine it developed with BioNTech will be sold for US$110 to US$130 per dose, from as early as the first quarter 2023.
Antibody-drug conjugate developer, Synaffix, has signed a licensing agreement with Cristal Therapeutics to gain access to its CliCr metal-free click chemistry.
The US Food and Drug Administration (FDA) has awarded 19 new grants and two new contracts totaling more than US$38m in funding over the next four years to support clinical trials and natural history studies related to rare diseases.
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for Biogen’s tofersen: with a decision now expected in April next year.
Colossal Biosciences spins out Form Bio, which emerges with funding and a software platform that is designed to be used across drug discovery, cell and gene therapy, manufacturing, and academic research.
The UK company makes two announcements for its Jemperli (dostarlimab) treatment, after it successfully cleared a Phase II trial and is set to enter a new Phase III trial in combination with cobolimab.
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharma’s developing treatments for Alzheimer’s disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid...
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.
A push toward multimodal businesses is encouraging greater reliance on contract development and manufacturing organizations (CDMOs), finds a new report.
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.
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.
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.
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.
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...
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...
