Sanofi will acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies. The acquisition will give it global rights to KY1005, which has the potential to treat a range of immune-mediated diseases and inflammatory...
Edesa Biotech, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's...
The US Department of Defense (DoD) and BARDA have expanded a partnership with AstraZeneca (AZ) to develop and manufacture its long-acting antibody (LAAB) combination, AZD7442, that may help treat or prevent infection with SARS-CoV-2.
Under an agreement with Zumutor, Catalent Biologics initiates clinical manufacture of the latter’s lead candidate targeting solid tumors, ahead of FDA filing.
Aiming to facilitate and accelerate discovery of biologics, Aridis’ Apex platform can also discover antibodies against viruses ‘within one day of a pandemic’.
Biosana to work collaboratively with the Bioprocessing Technology Institute, aiming to design a highly flexible and cost-effective continuous manufacturing solution.
GE Healthcare assigns Pharmadule Morimatsu to expand the offering of its ‘factory in a box’, known as KUBio, enabling the scale-up of biologics manufacture.
Samsung continues an agreement formerly signed with Glenmark to manufacture Ichnos’ mAb treatment candidate for atopic dermatitis, as the product enters Phase III clinical trials.
Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.
Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.
ABL will use WuXi’s platforms in an extended agreement for the development and commercialization of its bispecific antibodies, using the recently launched WuXiBody platform.
In another blow to discovering a treatment for Alzheimer’s, Roche revealed that preliminary data from two clinical trials meant it was cancelling studies using crenezumab.
The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.
Daiichi Sankyo announced it has entered into a clinical trial collaboration agreement with Merck & Co. to evaluate an investigational lung cancer treatment.
The National Institute of Allergy and Infectious Diseases is enrolling volunteers for a first-in-human experimental treatment trial for its mAb to treat the Ebola virus.
Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.
A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.
Celltrion has shelved plans for a third biomanufacturing plant at its site in Incheon in favour of an overseas site it says will help ensure biosimilar supply.
