News from the World of Clinical Research

Novavax begins COVID-19, flu combination vaccine trial

Novavax has launched a Phase I/II study evaluating a combination vaccine for the prevention of both COVID-19 and seasonal influenza, the US biotech company announced today.

Covid: Vaccine protection still strong - Oxford jab creator

The vaccines are still providing strong protection, a year on from the initial two doses, says the scientist who developed the Oxford-AZ vaccine.

AstraZeneca's COVID-19 shot joins the list of vaccines flagged for rare Guillain-Barre syndrome

Two months after the FDA flagged Johnson & Johnson’s COVID-19 vaccine for the rare nerve disorder Guillain-Barre syndrome (GBS) Europe’s drug regulator has done the same for AstraZeneca’s COVID sh…

At FDA meeting, gene therapy experts wrestle with field's blindspots

A group of gene therapy experts called for better research tools and more careful monitoring of side effects to treatment, but stopped short in a high-profile meeting Thursday of advocating for major …

NICE recommends Novartis’ Cosentyx for children with severe psoriasis

The National Institute for Health and Care Excellence (NICE) has recommended Novartis’ interleukin-17A (IL-17A) inhibitor Cosentyx (secukinumab) for the treatment of children and young people with mod…

Pfizer, Merck launch large new trials of oral COVID-19 drugs

• Pfizer and Merck & Co. each launched pivotal clinical studies of new experimental oral COVID-19 drugs, building on previous work to provide outpatient alternatives for patients.

Study finds protection against COVID-19 ‘waning’ in fully vaccinated people

New real-world study data has found that protection against COVID-19 is ‘waning’ in individuals who have received two vaccine doses.

ESC 2021: Lexicon aims to make its heart failure case with sotagliflozin, a dual SGLT1 and SGLT2 inhibitor

While much of the attention at the European Society of Cardiology (ESC) is expected to center on forthcoming heart failure data for Eli Lilly and Boehringer Ingelheim’s Jardiance, Lexicon Pharmaceutic…

With new Fate data, same promise, questions surround 'natural killer' cell therapy

• Fate Therapeutics reported new results for two early-stage studies testing two different types of experimental lymphoma treatments that utilize natural killer cells, a fast-emerging form of cancer im…

EC nod for Astellas, FibroGen’s roxadustat for chronic kidney disease

The European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

FDA OK's third dose of Moderna's COVID-19 vaccine for immunocompromised

The US Food and Drug Administration (FDA) has approved an update to the emergency use authorisation for Moderna’s COVID-19 vaccine – mRNA-1273 – to include a third dose for immunocompromised individua…

Covid: Carrie Johnson urges pregnant women to get vaccinated

Biden embraces Medicare drug price negotiation as Democrats seek to widen health coverage

President Joe Biden embraced congressional Democrats' broad drug pricing agenda, announcing Thursday his support for legislation that would allow Medicare to negotiate directly with pharmaceutical man…

Covid map: Coronavirus cases, deaths, vaccinations by country

Covid-19 is continuing to spread around the world, with more than 200 million confirmed cases and more than 4.2 million deaths across nearly 200 countries.

From vaccine halo to liability? Reputation tracker says COVID-19 shot makers now dinged for safety, supply issues

COVID-19 vaccine makers' time in the sun is over, according to one reputation tracker. The reputation boost ignited by the rush to find solutions during the pandemic has not only faded but now is turn…