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...
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
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...
Media reports claim the UK regulator is set to ban the use of COVID-19 Vaccine AstraZeneca in individuals below the age of 30 over blood clot risk concerns.
Pfizer and BioNTech’s COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in adolescents aged 12-15 years old, according to results from a Phase 3 trial released this week. “We plan to submit these data to the FDA as a proposed amendment...
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
COVID-19 mRNA vaccines are ‘highly effective’ in producing antibodies against SARS-CoV-2 in pregnant and lactating women; and also confer protective immunity to newborns, according to a new study.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents.
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
The European Medicines Agency (EMA) concludes that Celltrion’s monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.
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.
As tensions over COVID-19 vaccine supplies in Europe continue, AstraZeneca clarifies that a set of doses at its Anagni plant in Italy are destined for the EU and COVAX.
AstraZeneca has released the primary analysis from its COVID-19 vaccine US Phase 3 trial, showing 76% efficacy for the vaccine against symptomatic COVID-19. The company highlights that this backs efficacy data from Monday's interim analysis, responding...
The EU Commission has adapted its export authorization mechanism for COVID-19 vaccines, shoring up its ability to prevent shipments going to countries with advanced immunization rates and good access to vaccines.
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.
The pharma company and the CDC are recommending that adults continue routine vaccination during the COVID-19 pandemic to reduce future vaccine-preventable disease (VPD) outbreaks and overall strain on the healthcare system.
Thermo Fisher Scientific has announced a new, first-of-its-kind human plasma-like cell culture medium that more closely resembles the natural cellular environment found in the human body to provide researchers with a realistic view of cell growth.
The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated information’ when releasing initial data from its COVID-19 vaccine clinical trial.
Preclinical data shows that CureVac’s COVID-19 vaccine protects against challenge infections with the B.1.351 ‘South Africa’ variant in a transgenic mouse model.
Australia’s Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL – Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin....
