The agreement sees Provention Bio receive a non-refundable US$20m (€20.4m) payment and, in return, Sanofi has the exclusive right of first negotiation to in-license teplizumab for type 1 diabetes. Everything hinges on whether Provention can secure US Food and Drug Administration (FDA) approval for the treatment, which is currently under review for the delay of
Drugs
Merck, known as MSD outside of the US and Canada, announced that it had opened a new secondary packaging facility to support production of vaccines and biologics, particularly for its immunotherapy portfolio, including Keytruda (pembrolizumab). In addition, the company broke ground for an inhaler production facility that will be used to manufacture ‘new generation’ inhaler
The two companies entered into a strategic collaboration for novel mRNA-based PCV with Keytruda in 2016 with Merck paying Moderna $200m to lead research and development efforts through proof of concept. Now, Merck is exercising its option to develop a vaccine, currently in Phase 2 trials in patients with high-risk melanoma, with Moderna through to
Partial operations give Samsung Biologics fresh GMP biomanufacturing capacity of 60,000 liters. Total capacity of the plant will reach 240,000 liters once fully open in the first half of next year. Swift growth Samsung Biologics facilities are located close to Incheon International airport. Operations at Plant 1 begun in 2015, followed by two additional plants
The research, conducted with the University of Washington, was published in the peer-reviewed journal, Nature Partner Journals (NPJ) Vaccines. Lumen pioneered genetic engineering methods to highly express bioactive proteins in spirulina. The company said the research findings details how this platform was used to express a malaria protein antigen that can be delivered intranasally and
GSK received US Food and Drug Administration (FDA) approval for Jemperli in April 2022, when it became the seventh PD-1/PD-L1 treatment to enter the US market. Following the first approval in endometrial cancer, the treatment also received an accelerated approval for adult patients with mismatch repair-deficient recurrent or advanced solid tumors in August 2021. In
The study used the same adenovirus vector vaccine which is already licensed for use by injection. The trial enrolled 30 previously unvaccinated participants to receive a primary dose of the intranasal vaccine (some with one dose and some with two); as well as 12 participants who received it as a booster dose following a standard
The biotech has agreed a Letter of Intent with the State of Victoria in Australia to collaborate on the research and development of potential mRNA-based vaccines and therapies. As part of the partnership, the parties will establish a research and innovation center in Melbourne to facilitate the transition of encouraging academic research into clinical development.
Form Bio has been spun-out of Colossal Biosiences, which is a company that is focused on ‘de-extinction,’ having plans to resurrect extinct species, such as the woolly mammoth and thylacine (also known as the Tasmanian tiger). Through its work on the de-extinction process, Colossal developed software that combined artificial intelligence and biology. According to the
Boston-headquartered Ginkgo has significantly expanded its work in cell and gene therapy over the last few years, including a program to improve adeno-associated virus (AAV) manufacturing in partnership with Biogen, and a program to develop AAV capsids with altered tropism and immunogenicity in partnership with Selecta Biosciences. The field of nucleic acid therapeutics is a
Headquartered in Köln and founded in 2003, CEVEC Pharmaceuticals provides cell tech for the manufacturing of advanced biotherapeutics from R&D to manufacturing scale: with a portfolio covering various platform technologies for gene therapy vectors, vector vaccines and complex recombinant proteins. This includes its Elevecta tech for AAV manufacturing, CAP Ad tech for RCA-free adenoviral vectors,
Lecanemab is an anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD). Co-developed by Eisai and Biogen, the companies announced positive findings on the drug from the Clarity AD phase 3 trial on September 27, with the results suggesting lecanemab can slow cognitive and functional decline
Lexington, Mass.-based LogicBio has developed technology platforms for the delivery and insertion of genes to address genetic diseases, as well as a platform designed to improve viral vector manufacturing processes. Its foundational platform technology, GeneRide, differs from traditional gene therapy in that it harnesses the cell’s natural DNA repair process to integrate a corrective gene directly
The cell and gene therapy contract development and manufacturing organization (CDMO), which specializes in lentiviral and retroviral vector manufacturing, said the latest phase of the buildout sees additional process development, analytical development, and quality control labs as well as GMP cell banking and GMP vector manufacturing suites with an expanded GMP warehouse at the facility. The
The Denmark headquartered pharma group said it expects to file for regulatory approval of once-weekly insulin icodec in the US, the EU and China in the first half of 2023. On Monday the company announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes, a 52-week
The Darmstadt, Germany headquartered business combined its existing contract development and manufacturing organization (CDMO) and contract testing services in February this year; that CTDMO offer forms part of the recently formed Life Science Services (LSS) division. The objective: the strengthening of its CDMO offering and speeding up future growth. Millipore CTDMO services span pre-clinical to
The EMA recognizes that ATMPs – medicines for human use based on genes, tissues or cells – ‘offer groundbreaking new opportunities for the treatment of disease and injury’. But it also acknowledges the challenges faced by developers in getting new treatments from the lab to patients – including the regulatory complexity. The pilot will focus
The Gilead company says the approval makes it the only cell therapy company with in-house viral vector manufacturing capabilities for both clinical trials and commercial products. Furthermore, it strengthens the company’s global CAR T-cell therapy manufacturing network as it sees growing demand for its blood cancer treatments. ‘This milestone is several years in the making’
Coronaviruses are enveloped viruses by nature, making them prime targets for the company’s flexible eVLP technology, says the company. A Phase 1a/1b study of two monovalent, variant-specific vaccine candidates has already generated human proof-of-concept data, demonstrating safety, tolerability and immunogenicity of the platform. Now, the multivalent version is targeting BA.4 and BA.5 as well as
ODD is a status given to drugs intended to treat a rare disease that affects fewer than 200,000 people in the US and show promise in the treatment, prevention, or diagnosis of that disease. Benefits to the study sponsor include seven years of marketing exclusivity, federal tax credits, waiver of Prescription Drug User Fee Act
The drug in question is lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD). Japanese pharma group, Eisai, serves as the lead of the development of the drug and is responsible for regulatory submissions globally, while both it and US company, Biogen, are
The plant-based drug developer and contract development and manufacturing organization (CDMO) said the deal shores up its ambition to bring immunotherapies to the clinic, faster. The acquired assets include a patented system that uses artificial intelligencey (AI) to design 3D models of epitopes – which are the part of an antigen that is recognized by
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