An innovative manufacturing platform called integrated continuous manufacturing (ICM) represents a completely modernized model for drug manufacturing. In contrast to batch processes, ICM’s unique operational advantages will allow for cost-competitive end-to-end manufacturing and enable a more robust and responsive supply chain for critical drugs.
US biotechnology company Gritstone Bio has received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating the company’s self-amplifying mRNA (samRNA) vaccine candidate against Covid-19.
Pfizer's oral anti-viral Covid-19 treatment Paxlovid has won full approval from the US Food and Drug Administration (FDA) after Emergency Use Authorization was granted in late 2021.
The administration of US president Joe Biden is said to be wrangling with the Republican opposition in Congress to preserve funding for key components of the federal coronavirus response as the two sides fight over raising the debt ceiling to avert a government shutdown.
Examples of national logistics solutions in the UK, the Netherlands and Belgium show how high availability and low costs can be brought down to a common denominator.
The US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for the updated Covid-19 vaccines of both Pfizer/BioNTech and Moderna in children aged six months to five years.
After several delays and restarts and a lengthy review by the European Medicines Agency (EMA), the Covid-19 vaccine called VidPrevtyn Beta developed by the French-British partnership of Sanofi and GSK has been greenlighted by the European Commission.
Two globally oriented drugmakers, Pfizer and Sanofi, are making moves that some may interpret as attempts to allay the pharma industry‘s reputation for being “only in it for the money” but could potentially benefit poorer countries if all goes to plan.
Dorothee Arns, Director General of FECC, discusses current challenges, market trends and her vision for the chemical distribution industry in Europe. The interview was conducted by Michael Reubold and Ralf Kempf.
For its annual report "Value Creation in Chemicals 2021 – Ten Years of Steady Growth – and a Few Superstars," the strategy consultancy Boston Consulting Group examined the performance of leading international chemical companies from 2011 to 2020. The long-term perspective shows that the industry has mastered serious market downturns with astonishing confidence.
The Covid-19 vaccine Covifenz made by Canada’s Medicago, approved for use in the country in February, has been rejected for review by the World Health Organization (WHO) on grounds that the company is partly owned by tobacco company Philip Morris.
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose of their Comirnaty vaccine for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
As wealthy countries with ample supplies of Covid-19 vaccine struggle to convince more people to get the shot, and poorer countries struggle to nail down supplies, two US vaccine makers are making negative headlines. While EU and UK approval of the Novavax vaccine was just celebrated with fanfare, that company as well as Johnson & Johnson is now said to face delivery delays.
February kicked off with a major publicity coup for US vaccine maker Novavax, based in the state of Maryland. Its Covid-19 vaccine was granted conditional marketing authorization in the UK, Germany’s vaccine advisory panel recommended its use and the company officially filed with the FDA for emergency use authorization.
Pfizer and BioNTech are poised to begin their first clinical trial with a new vaccine candidate adapted to offer protection against the Omicron variant of the coronavirus. The study with 1,420 healthy adults aged 18 through 55 that will include some of the participants from the companies’ Phase 3 booster study is aimed at determining the potential need for variant-based vaccines.
In a 6:3 vote, the US Supreme Court has temporarily blocked the Biden administration from implementing its executive order requiring companies with more than 100 employees to have their staff vaccinated against Covid-19 or tested weekly. At the same time, it voted 5:4 to let stand the order requiring that all of the more than 10 million healthcare workers be vaccinated.
As the most recently documented Covid-19 variant, Omicron, continues to rapidly circle the globe – it has now been found in 57 countries and 21 US states, according to the US Centers for Disease Control – Pfizer and BioNTech have become the first vaccine manufacturers to claim that their booster shot can deal with it.
Fujifilm Diosynth Biotechnologies is investing £400 million to expand its Teesside site in northeast England, where it makes the active ingredient for the Novavax Covid-19 vaccine. The Japanese company said the expanded facilities are set to open in 2023 or early 2024, creating as many as 350 “highly skilled jobs” in contract manufacturing.
The UK has “pipped the US at the post”, as one commentator noted in typical British colloquialism on the news that the country’s health regulator MHRA has approved the Covid-19 antiviral pill molnupiravir developed by US Merck & Co together with US biotech Ridgeback Biotherapeutics.
Novavax has completed the submission of real time data to the UK’s Medicines and Health Regulatory Authority for the authorization of its Covid-19 vaccine candidate. It would be the first protein-based shot to be approved by the British drugs regulator.
Diverse developments taking place simultaneously in Covid-19 vaccines and treatments, especially in the US, are making it difficult for the average market watcher – and anti-vaccine enthusiasts – to keep up. While the past ten days have seen some concrete progress on boosters, following weeks of discussion, uncertainty lingers on some topics.
AstraZeneca has provided the US Food and Drug Administration (FDA) with encouraging study evidence that its antiviral cocktail candidate AZD7442 can prevent Covid-19 infections in vulnerable people, such as those who are unlikely to respond well to vaccines. This followed disappointing results from an earlier study.
A year ago unthinkable, the market for mRNA-based Covid-19 vaccines appears to be headed for saturation, even though, or perhaps because, there now seem to be more products on the market than first-world consumers want or need.
Phase 2/3 clinical trials with the Pfizer/BioNTech Covid-19 vaccine Comirnaty have shown that it is safe, well tolerated and produces robust neutralizing antibody responses in children aged 5 to 11 years, the companies said on Sept. 20. The vaccine partners now plan to submit the data to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies around the world “as soon as possible.”
German biotech CureVac has canceled manufacturing contracts with two prospective partners for its Covid-19 vaccine CVnCoV while retaining others. The company said on Sept. 14 it would end the arrangements with Germany’s Wacker Chemie and Switzerland’s Celonic Group, but leave the deals with Rentschler Biopharma and Novartis intact.
First to receive US approval under an Emergency Use Authorization (EUA) in late 2020, the BioNTech/Pfizer Covid-19 vaccine on Aug. 23 became the first to be fully approved by the US Food and Drug Administration (FDA) for marketing and use in the country.
As the delta variant of the coronavirus tears through the US, pushing both new and breakthrough infections higher, the US Centers for Disease Control (CDC) has now come out in favor of recommending that vulnerable individuals be given booster shots.
As it continues to grapple with documentation issues, US biotech Novavax has again altered its timeline for seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its two-dose Covid-19 vaccine. Concurrently, the US government is curbing some of the funding awarded last year by the administration of former president Donald Trump.
Pfizer and BioNTech applied to the US Food and Drug Administration (FDA) in May for full authorization of their Covid-19 vaccine Comirnaty, and in the interest of encouraging more Americans to get vaccinated the health agency is now conducting a priority review to speed the approval process.
As part of a new supply chain partnership, South Africa’s Biovac will produce Pfizer and BioNTech’s Comirnaty-branded Covid-19 vaccine at its Capetown site from the end of 2021, the companies announced this week.
Definitive results from CureVac’s 40,000-subject international Phase 2b/3 trial with its mRNA-based Covid-19 vaccine candidate, CVnCoV, have confirmed an earlier finding that it is only about 48% effective in preventing infection of any severity across the “unprecedented” 15 strains of the virus encountered during the tests with participants in Latin America and Europe.
South Korea-based CDMO SK Bioscience, with cash in hand from an initial public offering, has announced plans to pour 150 billion won ($132 million) into vaccine production up to 2024, which will mean to adding some 99,130 m2 of production space and equipping its plant at Andong to make newer mRNA- and viral vector-based Covid-19 vaccines.
In conjunction with its American Rescue Plan, the administration of US president Joe Biden has announced its intention to spend $3 billion on building a stockpile of pharmaceuticals that can be used to treat Covid-19 and other viral threats of the future.
The European Commission’s attempt to hold AstraZeneca (AZ) responsible for the delayed and truncated supply of its Covid-19 vaccine appears to have not produced the desired result, at least not in the first lawsuit to be heard.
In a stunning setback to the company’s ambitions of launching its mRNA-based Covid-19 vaccine in the third quarter, results from CureVac’s Phase 2b/3 trial showed the candidate branded CVnCoV to have an efficacy rate of only 47% against any severity of the disease.
