The US Health and Human Services (HHS) Office of Inspector General (OIG) is to launch a study on the use and spending trends for biosimilars in Medicare Part B.
Celyad Oncology has decided to voluntarily pause dosing and enrollment of patients in the CYAD-101-002 trial in order to investigate reports of two patient deaths.
TargED Biopharmaceuticals, a spin-off from the University Medical Center Utrecht that is developing therapies to improve treatment of thrombosis, has raised Series A financing of €39m (US$44.1m)
Semarion Ltd, a University of Cambridge spin-out company combining materials engineering and cell biology to tackle unmet drug screening needs, has just closed a £2.14m (US$2.89m) seed funding round.
4D Pharma says the US Food and Drug Administration (FDA) has cleared its IND application for the first in-human trial to use Live Biotherapeutics (LBPs) for the treatment of Parkinson’s disease.
Last week saw the WHO announce the first six countries that will receive the technology needed to produce mRNA vaccines on the African continent, as part of the global mRNA technology transfer hub project.
Contract development and manufacturing organization (CDMO), Recipharm, is now better placed to serve the advanced therapy medicinal products (ATMPs) market through two deals announced today.
The US biotech says it will establish a commercial presence in Belgium, Denmark, Norway, the Netherlands, Poland, and Sweden to support the delivery of mRNA vaccines and therapeutics locally.
The biologics CDMO market is expected to grow by US$8.65bn from 2021 to 2026, at a CAGR of 12.2% during the forecast period, according to new market data from Technavio.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
AskBio, a gene therapy company owned and operated as a subsidiary of Bayer AG, and Touchlight, a biotech focused on enzymatic DNA production, have announced a revised structure to their former joint venture, Touchlight AAV.
WuXi Biologics Cayman Inc suspended trading of its Hong Kong shares today after its inclusion of two of its units on the US government’s so-called unverified list of exporters triggered a record selloff, noted financial media outlets.
Planning for Institutional Biosafety Committee (IBC) oversight is a critical and often neglected initiation step for human gene transfer (HGT) clinical research, says an expert.
The US Food and Drug Administration (FDA) has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
Polyplus, a provider of transfection reagents, has acquired e-Zyvec, a France-based provider of DNA design and production services for tailor-made DNA vectors to expand expertise in plasmid DNA vector engineering.
AES Clean Technology, a supplier of cleanroom facilities for the pharmaceutical and biopharmaceutical sectors, is ploughing $14.2m into a new US manufacturing facility.
US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.
Contract development and manufacturing organization (CDMO), Recipharm, has acquired GenIbet, a Portuguese CDMO, specializing in the manufacture of biological clinical trial material.
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.
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.
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).
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.
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.
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.
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....
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.
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.
