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.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has acquired ADC Biotechnology (ADC Bio), a UK based company specializing in antibody-drug conjugates (ADCs).
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
Single-cell sequencing has helped with the understanding of the patterns of immune cells, which could help advance development of new therapies and new therapeutic targets, says a cancer research expert.
A UK study, which has been trialing the combination of Oxford-AstraZeneca and Pfizer vaccine doses, is now extending the program to include Moderna and Novavax vaccines.
The EU has entered into negotiations with Pfizer/BioNTech for a third COVID-19 vaccine contract: which would see delivery of 1.8 billion doses of the vaccine between 2021-2023.
British-Swedish pharma giant, AstraZeneca, has disclosed key preclinical data for AZD5305, its next-generation PARP1 selective inhibitor at the virtual American Association of Cancer Research (AACR) meeting this week.
Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week....
REGEN-COV (casirivimab with imdevimab) has been shown to reduce the risk of symptomatic SARS-CoV-2 infections by 81%, in a Phase 3 study among household contacts of infected individuals.
New research findings suggest that an immunotherapy assay enables determination of PD-L1 status in a high percentage of cancer patients and could guide personalized treatment selection.
Driven by encouraging clinical trial data, and a growing demand for effective and personalized therapeutic modalities, the CGT services market is anticipated to witness significant development, growing at a CAGR of over 25% up to 2030, forecasts a new...
Sanofi has acquired Cambridge, Massachusetts biotech Tidal Therapeutics: gaining its novel mRNA-based approach for in vivo reprogramming of immune cells.
Sanofi will build a digitally-enabled, carbon-neutral vaccine manufacturing center in Singapore: designed to respond quickly to future pandemic risks and able to produce up to four vaccines simultaneously.
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnson’s COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZeneca’s COVID-19 shot.
BeiGene has announced approval from the China National Medical Products Administration (NMPA) to begin manufacturing its anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.
The US National Institutes of Health (NIH) has started a clinical trial to determine whether people who are highly allergic, or have a mast cell disorder, are at increased risk of allergic reactions to the Moderna and Pfizer COVID-19 vaccines.
Valneva will take its COVID-19 vaccine candidate into a Phase 3 clinical trial this month, following positive Phase 1/2 data for the inactivated, adjuvanted vaccine.
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
The European Medicines Agency’s safety committee, PRAC, has concluded there is a possible link between the use of AstraZeneca’s COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.
Kite says a two-year retrospective analysis of the commercial manufacturing and supply of its CAR T therapy, axicabtagene ciloleucel (Yescarta), shows a high manufacturing success rate and a reliable turnaround time.
The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs,...
TCR2 Therapeutics Inc, a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, has signed a lease for an 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland: which is...
