Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.
US biopharma firm, TG Therapeutics, has announced an expanded contract manufacturing deal with Samsung Biologics to support the production of its investigational anti-CD20 monoclonal antibody, ublituximab.
The US Food and Drug Administration (FDA) has approved ADC Therapeutics’ ZYNLONTA as a third-line therapy for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
A test which uses artificial intelligence (AI) to measure proteins present in some patients with advanced bowel cancer could hold the key to more targeted treatment, according to a study published in Clinical Cancer Research.
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
When BioNTech calls 2020 a transformational year, it’s something of an understatement: with the company partnering with Pfizer to bring the first mRNA COVID-19 vaccine to market. So what’s next? BioNTech pledges to accelerate and expand its innovation...
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
US company, KIYATEC, says a new study has shown that its immune-modified ex vivo platform can measure treatment response through direct interaction between a patient's cancer and infiltrating immune cells, and immuno-oncology agents.
Precigen claims breakthroughs in CAR T cell therapy manufacturing that will eventually allow cancer centers to enable treatments earlier and at a lower cost.
GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
Affibody and Inmagene Biopharmaceuticals report that the US FDA has cleared the interleukin-17 (IL-17) blocker, izokibep, to proceed to phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.
Collaboration is not an unknown in the domain of pharmaceutical development, but it is rare enough. The demands of the COVID-19 pandemic, however, have seen competitors switch to become manufacturing allies.
Therapies for cancer, autoimmune diseases, inflammatory diseases and other drug markets are all siloed, despite new research emerging that shows potential connections between them. In order to create more effective therapeutics, we need to pull from research...
Moderna announced today that it is expanding its pipeline of innovative vaccines with three new development programs based on the 'clinical success' of its infectious disease vaccine portfolio to date.
UK company, Spirea, a spin-out from the University of Cambridge, which was founded to deliver the next generation of antibody drug conjugate (ADC) cancer therapeutics, has secured financing from o2h Ventures and Syndicate Room.
Rani Therapeutics, a clinical-stage biopharma company and developer of the RaniPill robotic pill, today announced that it has raised US$69m in a Series E financing round, bringing total funding to date to US$211.
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle...
BioInvent, a Swedish biotech focused on the discovery and development of immuno-regulatory antibodies for oncology, reports that it has been contracted as manufacturer of Cantargia’s antibody CAN10.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) gave a cautious welcome to the EU action plan on intellectual property (IP), published yesterday, expressing alarm, though, over proposals within it on compulsory licensing.
Eli Lilly and Company's neutralizing antibody bamlanivimab (LY-CoV555) has received interim authorization from Health Canada as a treatment for COVID-19.
Vibalogics has announced it is expanding its global footprint with a late phase clinical and commercial manufacturing facility near Boston, Massachusetts, a major milestone as it looks to advance its services to drug developers across the globe.
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary,...
Thermo Fisher Scientific Inc has inked a joint venture deal with Innoforce, a Chinese bioinnovation-enabling company, to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing....
Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.
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.
Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).
Contract development and manufacturing organization (CDMO), Cobra Biologics, has been selected to manufacture plasmids for a Phase I clinical trial of a COVID-19 vaccine being developed by UK company, Scancell.
Oslo headquartered, Vaccibody, a pioneer in the neoantigen cancer vaccine space, has entered into an exclusive worldwide license and collaboration agreement with Genentech.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
A project run by Gavi, the vaccine alliance, and the World Health Organization (WHO) to guarantee fair access to COVID-19 vaccines worldwide, has secured the backing of 64 higher income countries, with more set to sign up in the coming days.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01.
In a deal valued at US$21bn, Gilead Sciences is to acquire Immunomedics Inc, a New Jersey headquartered biotech that has been highly focused on breast cancer drug innovation.
An FDA regulatory request to Sarepta could delay the timeline for approval of its Duchenne muscular dystrophy (DMD) gene therapy if it results in a deferral of the start of a planned Phase 3 study for SRP-9001.
AbbVie has boosted its immunotherapy pipeline in a global licensing deal with Chinese biotech, I-Mab, for its anti-CD47 monoclonal antibody, lemzoparlimab.
