Novasep has signed a manufacturing services agreement with Exelixis, an oncology-focused US biotechnology company, for the cGMP clinical production of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC).
Bayer owned CDMO, Viralgen, has expanded its AAV vector manufacturing capabilities in San Sebastian, in the Basque region of Spain, with the opening last week of a new site.
Biotech, Mogrify, recently closed a Series A financing of US$17m, bringing the total raised to US$33m in the round, with the investment set to support the advancement of the company’s immuno-oncology and ophthalmology programs.
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a ‘strong body of evidence’ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual...
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
Iksuda Therapeutics, a developer of a new generation of antibody drug conjugates (ADCs), has expanded its research collaboration and license agreement with LegoChem Biosciences Inc (LCB).
Sorrento Technologies, a biotech firm developing novel treatments for COVID-19 and aggressive cancers such as melanoma, has received FDA clearance to start a research collaboration together with Mayo Clinic.
In recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including COVID-19 vaccines.
A lesson learnt from the COVID-19 pandemic was that human ingenuity prevailed and resolved an issue that challenged the world; the crisis also reinforced faith in the power of science, said Dr Albert Bourla, CEO of Pfizer, in a keynote interview during...
Co-administration of Novavax’s COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. “The findings suggest simultaneous vaccination may be a viable immunization strategy,”...
Evonik says it is working with Stanford University, California on a technology to deliver mRNA to tissues and organs that goes beyond the capabilities of lipid nanoparticles (LNPs).
Shoreline Biosciences and BeiGene have announced an exclusive worldwide strategic collaboration to develop and commercialize a portfolio of natural killer (NK) based cell therapeutics.
Dutch biotech, Byondis, today announced positive topline results from a Phase 3 study, which it says confirms the safety and efficacy of its antibody drug conjugate (ADC) - SYD985 - as a treatment for patients with pretreated HER2-positive locally advanced...
The Alzheimer’s Association has welcomed the FDA’s approval of aducanumab for Alzheimer’s disease, calling it ‘the beginning of a completely new future for Alzheimer’s treatments’.
Biogen pledges to share future insights about Aduhelm (aducanumab-avwa) with the scientific community as it collects more data from real-world use of the treatment, after the drug was approved by the FDA yesterday.
The virtual clinical development firm’s analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
UK-based biotechnology company, Iksuda Therapeutics, has completed a US$47m (£34m) financing round, which was led by Mirae Asset financial group and included a strategic investment from Korean biopharma player, Celltrion.
COVID-19 vaccination via Vaxxas’ novel high-density microarray patch showed 'significantly enhanced' T-cell and spike-specific antibody responses compared to needle delivery, according to a pre-print preclinical study published this week.
A Phase 3 study of BAT1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), has shown equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.
The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drug’s effectiveness in preventing worsening of symptoms and hospitalization.
Engine Biosciences, a Singapore- and Silicon Valley-based company with an artificial intelligence-enabled technology platform that is designed to discover new biology targets and disease-causing links amongst known targets, has generated US$43m in a Series...
Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.
Seasonal flu vaccines typically work 40-60% of the time, according to the US Centers for Disease Control and Prevention (CDC). An experimental recombinant protein nanoparticle vaccine that stimulates a strong immune response is hoping to address that...
Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to ‘redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors’.
Vaccine effectiveness against symptomatic disease from the B.1.617.2 (‘India’) variant is similar to that found against the B.1.1.7 ('UK') variant, according to a new study.
Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSK’s pandemic adjuvant.
Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.
Charles River Laboratories International Inc is to acquire US based Vigene Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions for research and clinical...
Synlogic is set to increase its manufacturing capacity by more than 50% in preparation for the start of late-stage development of its two lead drug candidates.
Sanofi and GSK announced today that their COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase 2 trial.
The antibody response in people aged 80+ is three and a half times greater when the second dose of the COVID-19 vaccine is administered after 12 weeks, compared to the response when the second dose is given after three weeks, according to a UK study....
Charles River says the combination of Distributed Bio’s platform, which the CRO recently acquired, with its own downstream characterization capabilities, enables identification of the best lead candidate in CAR T cell therapies – balancing efficacy and...
Eli Lilly and Company and MiNA Therapeutics Ltd have announced a global research collaboration to develop novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform.
US contract research organization, PPD Inc, is expanding its Athlone, Ireland, GMP laboratory, significantly increasing the size of its current facility and adding cell and gene therapy (CGT) testing to the operation’s portfolio of services.
Flagship Pioneering has unveiled Laronde: a platform company developing Endless RNA. Endless RNA is a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body: ‘a groundbreaking therapeutic platform capable...
Sanofi and Stanford University School of Medicine have established a three-year research collaboration: focusing on autoimmune diseases and inflammatory conditions.
Last month saw ATMPS Ltd, a developer of blockchain-based cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, come together in an alliance aimed at creating seamless...
