Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drug delivery systems for newly developed biologics along with medical and diagnostic products.
Eli Lilly and Company and Banner Alzheimer’s Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimer’s disease.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
Aiming to facilitate and accelerate discovery of biologics, Aridis’ Apex platform can also discover antibodies against viruses ‘within one day of a pandemic’.
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.
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.
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.
Sanofi will use AbSci’s platform to further optimize two of its in-house proteins – and will partner with other companies to accelerate timelines and reduce costs.
Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.
US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab).
Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.
Pfizer has earmarked two sites in the UK for closure, including an ex-Hospira aseptic plant in London it says would need ‘significant investment’ to remain open.
CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).
Catalent and Zumutor Biologics have combined their technologies to create antibodies with enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without compromising production levels.
The partnership with recombinant protein development firm GTP Technologies will create an end-to-end manufacturing service, speeding up production of monoclonal antibodies and reducing costs, says Novasep.
JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.
Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
Manufacturing backlog at Avid Bioservices has reached $42m as the firm books up space at a new facility currently undergoing its first internal pilot run.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
MedImmune, the biologics R&D arm of AstraZeneca, and the US National Institute of Standards and Technology (NIST) have signed a five-year agreement to support research that will help advance drug discovery and biomanufacturing.
Sanofi has selected Boehringer-Ingelheim to manufacture monoclonal antibodies in an agreement that extends to the French drugmaker's partner Regeneron.
Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
Interest in the US biosimilars market is still growing despite Big Pharma delaying tactics and continuing regulatory uncertainty according testing services CRO, BioOutsource.
German CMO Rentschler landed APN311 production deal thanks to location and cell culture based manufacturing skills according to BioPharma Apeiron Biologics.
Merck Millipore hopes the promise of reducing the number of experiments needed during process development will win customers for its new MAb development kit.
Outsourcing-pharma.com presents a roundup of contract manufacturing news with deals for Lonza, DSM and Ark Therapeutics and an expanded agreement with Shire for AMRI.
