Continuous bioprocessing facilities can be more cost-effective than stainless steel batch plants when total out-of-pocket costs across development and commercial activities are factored in, according to a 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...
RoslinCT is set to collaborate with the Scottish Universities Life Sciences Alliance (SULSA) and additional academic institutions to deliver high impact advanced therapy and vaccine manufacturing GMP training.
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.
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine: now including adolescents aged 12-15 years old.
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...
BioNTech plans to expand its global footprint with a regional headquarters for South East Asia in Singapore; as well as a fully integrated mRNA manufacturing facility.
Ontario-based, Nicoya Lifesciences, is in the process of completing a prototype of a low-cost, single-use device that tests for active SARS-CoV-2 infection, variants and, eventually, other viruses. The novel test is called Atlas.
Sanofi and Stanford University School of Medicine have established a three-year research collaboration: focusing on autoimmune diseases and inflammatory conditions.
The US says it will support the proposed waiver of IP protections on COVID-19 vaccines: but the country’s industry says this sets a ‘dangerous precedent for future pandemics’.
Moderna has reported the first profitable quarter in the company’s history: after 10 years of research and several billion dollars of investment in its mRNA platform. The next step will be to start a rolling submission for a Biologics License Application...
A new report published by Meticulous Research shows the continuous bioprocessing market is expected to grow at a CAGR of 22.9% from 2020 to 2027 to reach US$197.8m by the end of the period.
French pharma services provider, Clean Biologics, has acquired Canadian CDMO, Biodextris, in a move it says will boost its analytical and process development, and early-phase clinical manufacturing and quality control testing services for clients in the...
Takara Bio Europe has announced a licensing agreement with Denmark’s PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.
Pfizer has upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn: as well as reporting strong Q1 results for the business overall this morning.
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...
Meissner Filtration Products has just been awarded a US$13.4m contract from the US government agency, BARDA, to boost its production capability for components critical to vaccines and therapies linked to the COVID-19 response.
Moderna has announced a set of additional investments to allow it to increase global supply of its COVID-19 vaccine. ‘We believe there will continue to be significant need for our vaccine into 2022 and 2023’, says the company.
As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.
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.
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
A Phase 2b trial for the University of Oxford’s malaria vaccine candidate showed 77% efficacy in children, according to a study published in The Lancet. ‘We believe this vaccine could have a major public health impact’, say researchers.
The European Commission has decided to bring legal proceedings against AstraZeneca, it confirmed today. But AstraZeneca says the litigation is without merit, adding it will ‘strongly defend itself’ in court.
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.
Bristol Myers Squibb (BMS) will build a new cell therapy manufacturing site in Leiden, the Netherlands: marking the company’s first cell therapy manufacturing facility in Europe and its fifth globally.
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.
Synthetic biologists based at Northwestern University in the US have discovered a new way to increase production yields of protein-based vaccines five-fold, significantly broadening access to potentially lifesaving medicines.
The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains...
SparingVision will acquire GAMUT Therapeutics, the biotech behind a gene-independent approach to treat the later stages of rod-cone dystrophies such as retinitis pigmentosa (RP).
The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
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...
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
Memorial Sloan Kettering (MSK) experts shared research findings in plenary talks during the American Association for Cancer Research’s (AACR) virtual meeting last week, with one talk reviewing the latest strategies for boosting the effectiveness of CAR...
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
