Biotech | 09 October 2021
Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
Alnylam is the latest partner in the Medicines Manufacturing Innovation Centre’s third Grand Challenge project, which aims to revolutionise the manufacturing process for oligonucleotide therapies
The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
The aim is to first produce Covid-19 vaccines and then add more vaccines in the years to come
Early-stage research suggests the potential to prevent and treat all dengue serotypes and builds on Johnson & Johnson's work to advance science against emerging and entrenched global public health threats
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
The 462,000 square foot state-of-the-art building targeting LEED Zero certification and is designed to be the most sustainable commercial lab building in Cambridge
The company plans to submit the IND application by the end of 2021
Takeda to exclusively commercialize JR-141 outside the U.S. (except Japan and certain other Asia-Pacific countries) upon regulatory approval
If cleared, Merck's drug would be the first pill shown to treat Covid-19, a potentially major advance in efforts to fight the pandemic
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
The company does not expect the outcome of this inspection to impact its plans
Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors
saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level
CuraTeQ Biologics is on track for filing a second oncology biosimilar
Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has announced it will invest in additional drug product manufacturing capabilities in Switzerland
The addition of Abexxa’s expertise complements Boehringer Ingelheim’s current approaches to the treatment of difficult-to-treat solid cancers and especially those resistant to available immunotherapies
Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs
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