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.
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.
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.
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...
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.
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.
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.
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.
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.
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.
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.
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...
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.
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 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.
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.
![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)
