GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
Affibody and Inmagene Biopharmaceuticals report that the US FDA has cleared the interleukin-17 (IL-17) blocker, izokibep, to proceed to phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.
Novartis reported today that a clinical trial of the drug, known as canakinumab, when combined with chemotherapy agent, docetaxel, failed to extend the lives of patients with advanced or metastatic non-small cell lung cancer compared to just chemotherapy...
A global economic recovery is in sight but a faster and more effective vaccination rollout across the world is critical, while respecting necessary health and social distancing measures, according to the OECD’s latest Interim Economic Outlook.
A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical...
The European Medicines Agency (EMA) has started a rolling review of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.
China's Pharmaron has entered into a definitive agreement to acquire the Allergan Biologics Limited (ABL) site in Liverpool, UK, for US$118.7m in cash from AbbVie.
Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development...
The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.
The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.
WuXi AppTec has completed its acquisition of Oxgene, a UK contract research and development organization that designs and develops scalable gene therapy technologies.
This week France has raised the age limit for the AstraZeneca COVID-19 vaccine; but Canada, conversely, has put a 65-year-old limit into its recommendations.
The Pfizer/BioNTech COVID-19 vaccine – which requires ultra-cold storage – will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...
A program at the University Hospital of Tübingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.
Clover Biopharmaceuticals today announced that it has raised US$230m in Series C financing, bringing to over US$400m the funds it has generated in the past 12 months.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
AstraZeneca is voluntarily withdrawing the use of its cancer drug, Imfinzi, to treat advanced bladder cancer in the US after it did not meet post-approval requirements.
Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
The UK government has announced the launch of the Advanced Research and Invention Agency (ARIA), an initiative to fund “high-risk, high-reward” scientific research in the hope of achieving “groundbreaking” discoveries.
Quotient Sciences, a drug development and manufacturing accelerator with facilities in the UK and the US, has acquired Arcinova, a UK-based multiservice contract development and manufacturing organization (CDMO).
Avacta says data from ongoing clinical studies in Europe and the UK show excellent performance of its SARS-CoV-2 rapid antigen test in identifying patients with an infectious viral load and no false positive results.
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following...
Massachusetts-based clinical research organization (CRO), Charles River Laboratories, is to acquire Cognate BioServices, a cell and gene therapy contract development and manufacturing organization (CDMO) for around US$875m in cash.
AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO): meaning the vaccine can be rolled out globally through COVAX.
Scotland’s University of Glasgow has entered into a research collaboration with pharma group, Eli Lilly, to develop the next generation of drug targets for immunological diseases.
From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.
CureVac has initiated a rolling review with the European Medicines Agency (EMA), working towards authorization for its mRNA COVID-19 vaccine in the European Union.
While some jurisdictions have limited the use of the Oxford University / AstraZeneca COVID-19 vaccine, the WHO says it can be used even where variants are known to be in circulation and with people aged 65+.
Announcing its financial results for 2020, AstraZeneca has said that it could take between six and nine months to develop shots that are effective against new variants of COVID-19.
AstraZeneca and IDT Biologika are exploring options to accelerate output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021 in order to help support Europe’s immediate vaccination needs during the pandemic.
Collaboration is not an unknown in the domain of pharmaceutical development, but it is rare enough. The demands of the COVID-19 pandemic, however, have seen competitors switch to become manufacturing allies.
UK catalyst organization, CPI, has announced the launch of a project that aims to revolutionize the manufacture of oligonucleotides, through a collaboration involving, among others, AstraZeneca, Exactmer, and Novartis.
Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russia’s Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
By Mike Pears and Joel Beevers, Patent Attorneys at Potter Clarkson
January 1, 2021 marked the UK’s official separation from the EU and with that has come a raft of changes to how the nation will now do business with the rest of the world.
EU pharma industry representatives have expressed concern that the recently enacted EU export transparency mechanism could risk production delays or jeopardize the supply of COVID-19 vaccines in Europe.
J&J pledges to start shipping doses of its COVID-19 vaccine in the US as soon as Emergency Use Authorization (EUA) is received from the Food and Drug Administration, while it plans to apply for Conditional Marketing Authorization in the EU in the...
Novavax has started sharing early clinical data for its COVID-19 vaccine with health authorities in the UK, EU, US and Canada as it starts the rolling review process in these jurisdictions.
South Africa is halting the use of the Oxford University-AstraZeneca COVID-19 vaccine in its vaccination campaign following the release of trial data showing the jab offered limited protection against mild to moderate infection caused by the country’s...
