PackGene Biotech, an adeno-associated virus (AAV) vector contract research organization (CRO) and contract development and manufacturing organization (CDMO), is expanding its US services with a new cGMP biomanufacturing and processing facility in Houston....
The Boston-based messenger RNA (mRNA) specialist Moderna revealed $19.3bn in revenues last year, but rising costs and falling demand for its COVID-19 vaccine cut into its earnings in the fourth quarter of 2022.
The US Food and Drug Administration (FDA) has approved Sanofi and Sobi’s Altuviiio (efanesoctocog alfa): a first-in-class, high-sustained factor VIII replacement therapy.
Chinese companies Porton Advanced Solutions and Yinjia Biosciences have signed a pact aimed at supporting further development of cell and gene therapies.
The messenger RNA (mRNA) specialist Moderna has teamed up with ElevateBio-owned Life Edit Therapeutics to develop gene editing therapies that are delivered into patients in vivo.
After voluntarily pausing a phase 1/2 trial due to safety concerns in January 2023, the gene edited cell therapy firm Graphite Bio has discontinued the development of nulabeglogene autogedtemcel (nula-cel), its lead candidate cell therapy for sickle cell...
An experimental antibody drug developed by Regeneron Pharmaceuticals called pozelimab could become the first approved treatment of the hereditary immune disease CHAPLE, with a US Food and Drug Administration (FDA) approval decision expected by August...
mRNA therapeutics have received increased amounts of attention and funding ever since mRNA vaccines proved effective in curbing the spread of the COVID-19 pandemic. Now, researchers are exploring mRNA therapeutics’ use in other disease spaces, reports...
Daiichi Sankyo is kitting out a plant, based near Tokyo in Kitamoto, with equipment to enable the production of an mRNA vaccine against COVID-19, according to a Nikkei Asia report.
The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.
Donaldson Company will acquire Isolere Bio: an early-stage biotech that develops novel and proprietary ‘IsoTag’ reagents and accompanying filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals.
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...
Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.
Phase 3 interim data showed the mRNA vaccine candidate generated a strong immune response against Influenza A; but failed to demonstrate it was at least as effective as an existing vaccine against Influenza B.
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.
California based, Theragent, a cell therapy CDMO, has signed a multi-year exclusive contract with Insight68, an AI-driven software provider that aims to digitalize and streamline the cell therapy manufacturing process.
Minaris Regenerative Medicine, a contract development and manufacturing organization (CDMO) for cell and gene therapies, is pairing up with LIfT BioSciences on development and manufacturing for a first-generation advanced therapy medicinal product (ATMP).
The clinical stage biopharmaceutical company will use its RADR artificial intelligence (AI) and machine learning platform to transform the cost, pace, and timeline of oncology drug discovery and development.
Biotage will acquire Astrea Bioseparations, a chromatography solutions provider, from Gamma Biosciences: extending its chromatography franchise into the bioprocessing market for biologics and advanced therapeutic customers.
Bavarian Nordic will acquire two travel vaccines – typhoid fever vaccine Vivotif and cholera vaccine Vaxchora - alongside a Phase 3 Chikungunya vaccine candidate: as well as facilities in the US and Switzerland.
New company Syena says it has the potential to create the next generation of cell therapy: combining the safety, potency and scalability of natural killer (NK) cells with the ability of T cell receptors (TCR) to target intracellular tumor antigens.
Switzerland headquartered Lonza said it is expanding its early development services (EDS) to North America, opening a new laboratory in Cambridge, Massachusetts (US).
Australia’s Vaxxas has initiated a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate.
Scancell has reported preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial: with the plasmid DNA COVID-19 vaccine candidates inducing immune responses when delivered via needle-free tech.
Genentech is to build a new biologics facility at its Oceanside, California campus that it says will be at the forefront of next-generation manufacturing and environmentally sustainable production for small-batch commercial biologics.
The Cell and Gene Therapy Catapult (CGT Catapult) has confirmed its involvement in the development of a new £900m ($1,097m) life science campus in Stevenage, UK: which is set to become one of the largest in Europe.
SK bioscience has announced its largest ever investment to establish the Songdo Global Research & Process Development Center. As well as supporting the company’s work in mRNA, CGT and viral vectors; the site’s Open Lab will welcome external stakeholders...
The South Korean player plans to expand its recently acquired US facility, to provide contract manufacturing services for Antibody Drug Conjugates (ADC), and to add drug product fill & finish facilities to establish a foothold in the North American...
TILT Biotherapeutics, a Finnish company developing cancer immunotherapies, reported the final close of its €22m (US$23.8m) round, which was led by Finland’s Lifeline Ventures, an early-stage venture capital firm.
Releasing the first global Phase 3 data for crovalimab, Roche highlights the potential for 'robust disease control with less frequent treatment intervals'.
Around 25% of US venture capital biopharma investments flowed to Massachusetts in 2022: cementing the state’s position as a leader in the industry. But how will economic uncertainty affect the hub’s fortunes moving forward?
US contract development and manufacturing organization, Catalent, reported results today for the second quarter of fiscal 2023, which ended December 31, 2022.
Pfizer currently has an unprecedented number of anticipated launches, says its CEO: with the company expecting to have up to 19 new products or indications in the market in the next 18 months.
The project is the first phase of a wider strategic initiative to expand capacity and enhance end-to-end biologics development and manufacturing services at the US CDMO.
