Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
A holistic approach to decentralized clinical trials that combines intentional design, stakeholder collaborations, and user-friendly technology is what’s needed to execute global clinical trials more efficiently, argues an expert.
Gavi, which manages COVAX, the global COVID-19 vaccine sharing scheme, says it has secured much-needed vaccines from Chinese producers, Sinovac and Sinopharm.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
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.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
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.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
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.
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
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,”...
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
Eli Lilly and Co received a subpoena late last week from the US Department of Justice (DOJ), requesting certain documents, as part of a probe into its manufacturing site in Branchburg, New Jersey.
Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.
The World Health Organization (WHO) and the Swiss Confederation have launched the first WHO BioHub Facility to enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.
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...
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.
The European Commission today announced that it has reserved an additional 1.8 billion doses of the coronavirus vaccine developed by Pfizer-BioNTech, on behalf of all 27 EU countries, from the end of 2021 to 2023.
Becton, Dickinson and Company (BD) is to build a new plant in Zaragoza, Spain, with an investment of €165m (US$200m). The site will produce glass pre-filled syringes and plastic components.
Excipient producer, DFE Pharma, is expanding its reach, capitalizing on increasing growth in the biologics sector, and launching a new sucrose stabilizer.
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.
Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...
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....
Moderna has agreed to provide 15m doses of its updated variant COVID-19 vaccine to Australia, providing a boost to its efforts to generate ongoing revenues from its coronavirus work.
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.
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.
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.
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.
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.
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.
![WHO Director-General, Tedros Adhanom Ghebreyesus and Swiss Federal Councillor, Alain Berset, signed an agreement in relation to the BioHub on the edges of the World Health Assembly yesterday [May 24] © WHO/Christopher Black](/var/wrbm_gb_food_pharma/storage/images/_aliases/news_teaser_medium/publications/pharmaceutical-science/biopharma-reporter.com/article/2021/05/26/new-switzerland-hub-for-pathogen-storage-sharing-and-analysis/12512537-4-eng-GB/New-Switzerland-hub-for-pathogen-storage-sharing-and-analysis.jpg)
