Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimer’s drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.
Cryoport, Inc. has entered into a partnership with specialized Belgian CDMO, Cell Matters, to deliver end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies.
Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for autoimmune diseases, has closed an oversubscribed $85m Series B financing round led by Northpond Ventures.
Contract development and manufacturing organization (CDMO), Recipharm, says it has inked a deal with a top 10 big pharma company to support vaccine manufacturing from its facility in Kaysersberg, France.
Over the last 18 months, Aceto has made a series of manufacturing acquisitions, allowing it to better serve customers in biopharmaceutical, vaccine and pharmaceutical industries. It is now investing in several of its newly-acquired North American facilities:...
Contract packaging and clinical supply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies at its facility in Heerenveen, The Netherlands.
Last year was the highest year on record for investments into UK biotech and life science companies: with £4.5bn ($6bn) raised in public and private financings, representing 60% more than in 2020.
Netherlands-based gene therapy company, VectorY Therapeutics, and Wageningen University have signed a strategic collaboration agreement for the development of novel baculovirus-based AAV production technologies.
Japan’s ministry for health has approved Abecma as a CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies.
GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
Biotech EdiGene has announced an R&D collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology.
Pfizer and BioNTech expect to produce four billion doses of their COVID-19 vaccine in 2022: regardless of whether the current vaccine or a new Omicron specific vaccine is needed.
Valneva announced yesterday that results from a lab study showed three doses of its inactivated COVID-19 vaccine candidate, VLA2001, neutralized the Omicron variant.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to improve and strengthen UK clinical trials legislation.
Automated cell therapy manufacturing processes could reduce manual intervention and human errors, enabling more robust processes, improved product quality, and lower costs.
Adeno-associated virus (AAV) hold potential for use in numerous gene therapies: with demand only set to grow as more therapies are developed and approved. However, supply of AAV is one of the challenges for the sector. In a study published in Biotechnology...
Downstream biomanufacturing is expected to witness a high CAGR over the next 10 years: driven by continuous product innovations in chromatography product lines and filtration systems.
Orgenesis and The Johns Hopkins University will construct a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins.
Ori Biotech Ltd, an innovator in the cell and gene therapy (CGT) manufacturing sphere, has secured over US$100m in an oversubscribed Series B funding round.
Charles River and La Jolla Institute for Immunology (LJI) are collaborating on a new project to uncover how different cells in the human immune system respond to SARS-CoV-2 in early, acute infection.
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
Vir Biotechnology and the Bill & Melinda Gates Foundation have partnered up to develop broadly neutralizing antibodies designed to provide a ‘vaccinal effect’ for the treatment of HIV and prevention of malaria.
The UK government's Vaccine Taskforce (VTF) is looking to increase its understanding of barriers, risks, and opportunities to facilitate investment in the vaccine supply chain.
Andelyn Biosciences says the FDA's acceptance of its GMP plasmid DNA drug master file (DMF) enables the CDMO to vertically integrate its clients’ manufacturing process, condensing timelines for developers to begin manufacturing to just three months....
Performance Cell Manufacturing, a CDMO with a focus on manufacturing cell therapies, has been acquired by Great Point Partners and will now operate under the name Cellipont Bioservices.
Samsung Biologics flags further facility construction plans, with biologics, cell and gene therapies and next-generation vaccines to be the focus of those new sites.
This week the US Centers for Medicare & Medicaid Services (CMS) has announced a long-awaited proposal for Aduhelm coverage: proposing it would only cover the recently approved Alzheimer’s Drug for people in qualifying clinical trials. This could have...
Protagen, BioAnalytix, and GeneWerk this week announced their unified operations and re-brand as ProtaGene, a CRO partner for the biologics and cell and gene therapy developers, from discovery to commercialization.
Healthcare investors, GHO Capital Partners LLP, have invested in Scotland based, RoslinCT, a contract development and manufacturing organization (CDMO) focused on advanced cell therapies.
Wheeler Bio, a newly established company aiming accelerate the translation of therapeutic innovation into clinical impact, recently closed a US$14m seed financing round.
While the last two years have seen the successful development of COVID-19 vaccines, the emergence of variants highlights the speed at which the pandemic - or indeed any other virus threat - can evolve. As a result, development of novel vaccine candidates...
BioNTech and Crescendo, a clinical stage immuno-oncology company developing targeted T cell enhancing therapeutics, have entered a multi-target discovery collaboration to develop novel immunotherapies for cancer and other diseases.
Alexion, AstraZeneca’s Rare Disease group, has entered into an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin...
Bayer AG and Mammoth Biosciences, Inc., have announced a strategic collaboration and option agreement for the use of Mammoth’s CRISPR systems to develop in vivo gene-editing therapies.
Life science investor group, Novo Holdings, has agreed to buy Ritedose, the largest sterile CDMO in the US focused on advanced blow-fill-seal technology, from Hong-Kong based, AGIC Capital, and China’s Humanwell.
Belgium’s Univercells has acquired SynHelix, a biotechnology company that aims to debottleneck biotherapeutics development through automated DNA synthesis.
Clover Biopharmaceuticals, a clinical-stage biotech developing novel vaccines and biologic therapeutic candidates, has started construction on a new R&D Center in Zhangjiang Biotech and Pharmaceutical Industrial Base in Shanghai.
Pfizer and BioNTech, in what will be the third mRNA vaccine collaboration between the two companies, are teaming up on the development of a vaccine for the prevention of shingles.
ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US quality and compliance consultancy, Assurea LLC, to develop a fully complaint blockchain approach for end-to-end supply chain management...
