A T-cell engaging bispecific antibody developed by Roche has got its first green light in Canada for the treatment of relapsed or refractory forms of the blood cancer diffuse large B-cell lymphoma (DLBCL).
Swiss CDMO Lonza has increased capacity and capabilities at its Visp, Switzerland site, with the completion of a new line for cGMP clinical and commercial drug product manufacturing.
The US biotech CytomX has lost a collaboration partner as AbbVie pulled out of a collaboration developing an antibody-drug conjugate (ADC) for the treatment of solid tumours.
Pharmaron Beijing Co Ltd says its Liverpool, UK based gene therapy CDMO has obtained a grant from the UK government’s life sciences innovation manufacturing fund (LSMIF) to expand its facilities.
BrainStorm Cell Therapeutics reports that the FDA is to hold an advisory committee meeting to discuss the company’s BLA for NurOwn, a personalized stem cell treatment targeted at ALS.
Vertex will pay CRISPR Therapeutics $100m up-front for non-exclusive rights to its technology with the goal of developing a certain type of therapy for diabetes.
The White House releases a report detailing how it will harness biotechnology and biomanufacturing to address numerous societal challenges, including human health.
Remedium Bio, a US biotech, and Exothera, a Belgian CDMO, have established a collaborative agreement in relation to the US firm’s disease modifying gene therapy for osteoarthritis, AAV2-FGF18.
UPS Healthcare says its first dedicated healthcare logistics facility in Giessen, Germany is now up and running. Up to 150 jobs have been created as a result of this operation, added the provider.
mRNA pioneer Moderna wants to grow and thrive past its initial COVID-19 vaccine success. “To continue to build the best version of Moderna, we have established seven priorities for 2023,” says CEO Stephane Bancel: as the company outlines goals that range...
A US FDA panel of advisors concluded that there was a lack of substantial evidence to indicate that Biogen’s investigational drug, tofersen, was effective in treating a rare and aggressive form of ALS. But the experts voted unanimously that the investigational...
BioNTech and OncoC4 have announced a worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications....
Oxford UK based Vaccitech reports positive topline interim data from a Phase 1b/2 clinical trial of VTP-200 in women with low-grade cervical human papillomavirus (HPV) lesions.
Orgenesis is pairing up with University of California, Davis (UC Davis) to deploy cell and gene therapy mobile processing units and labs across California.
Novartis has presented new data which ‘underscore the transformational and sustained benefit’ of spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec): with treated children maintaining motor milestones after 7.5 years.
Alpha Teknova Inc is teaming up with Sartorius BIA Separations, part of the Sartorius life sciences group, to help gene therapy companies streamline the downstream purification process.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10m ($12m) in extra government funding over the next two years: targeted at helping the agency adapt post-Brexit and accelerating routes for bringing new medicines onto the...
Intergalactic Therapeutics, a startup focused on non-viral gene therapy, reports positive preclinical results for its lead program, IG-002, addressing all forms of ABCA4-related retinopathies.
Teitur Trophics, a startup looking to prevent the death of neurons in neurodegenerative diseases, has completed a €28m (US$29.9m) Series A financing round co-led by Sunstone Life Science Ventures and Sound Bioventures.
Moderna will expand in the US with new offices in San Francisco and Seattle: while the company also expects to hire around 2,000 new employees globally this year.
The new Clinical Biotechnology Centre (CBC) in Bristol will expand the UK’s ability to make clinical grade products for the research and development of new cell and gene therapies.
The extremely high costs of gene therapies are unsustainable, and a global commitment to affordable, equitable access to these treatments is urgently needed, concluded the organising committee of a conference on human genome editing.
In acquiring antibody-drug conjugates technology pioneer Seagen, Pfizer eyes up the strong growth trajectories of Seagen's medicines and the potential of its pipeline and technology.
Sanofi will acquire US-based Provention Bio: gaining Tzield (teplizumab-mzwv), which was approved by the FDA last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes.
Businesses and individuals that have money deposited with failed US bank Silicon Valley Bank (SVB) will be able to access all their cash from today, said the US government.
Evonik has opened a new GMP facility to manufacture lipids for advanced pharmaceutical drug delivery applications, which is situated at the company’s site in Hanau, Germany.
OPKO Health’s ModeX Therapeutics has entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX-2201, ModeX’s preclinical nanoparticle vaccine candidate targeting EBV.
Moderna’s RSV vaccine launch – expected either late this year or early in 2024 – will draw on the infrastructure and learnings gained from the company's COVID-19 vaccine launch.
The Biosimilars Forum has welcomed a move by US congressman, Richard Hudson, to introduce legislation that would establish a shared savings reimbursement model for biosimilars in Medicare Part B.
A US Food and Drug Administration (FDA) advisory committee has recommended both Pfizer and GSK’s RSV vaccines: with a decision from the agency expected in May.