Drug Development
A trial of a MacroGenics’ drug temporarily paused enrollment after several safety events, including a fatality. The deceased patient had developed a severe case of neutropenia and concurrent septic shock.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
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Tapinarof’s potential remittive effects could hold even more value for long-term psoriasis suffers. For patients coming into the trial with a PGA score of 0 (n=78), median time to the disease worsening (defined as a PGA score of ≥2) after discontinuing treatment was approximately 115 days, or 4 months.
With distribution of COVID-19 vaccines being slow, public health officials and researchers are trying to develop schemes and rationales for delaying the dosing of the second shots.
Several mutations of the SARS-CoV-2 virus that causes COVID-19, which are being called variants, are increasingly being found around the world.
Currently, research is still ongoing with regards to the link between COVID and POTS. However, this increasing number of cases and the unfamiliarity of COVID’s long-lasting effects leave a lot more for the researchers to unmask.
COVID-19 reinfections are occurring but, so far, scientists don’t have all the details.
With the COVID-19 vaccine rollout underway and a renewed sense of hope stemming from an aggressive vaccine dispersal plan, a common question has begun to emerge.
In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests.
In Phase III studies, Eli Lilly’s tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes.
In 2020, Vir and GlaxoSmithKline partnered to develop strategies against COVID-19. The two companies have expanded that collaboration to include work into new treatments for influenza and other respiratory viruses.
As COVID-19 vaccine rollouts intensify across the country, employers across all industries are trying to decide whether they should implement a mandatory vaccine policy before they let employees back into the office.