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A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications. Read More
The company is working with regulators in the U.S., Europe and the UK to find ways to gain approval for this drug for the treatment of COVID-19. Read More
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease. Read More
The European Medicines Agency (EMA) has issued draft guidance on redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). Read More
Many biopharmaceutical sponsors are prepared to see the costs of outsourcing increase for their clinical trials in 2022 as the practice is expected to significantly increase this year, according to an industry survey by Baird. Read More
Despite the disappointing results, Theravance is still investigating the drug as a potential treatment for patients with multiple system atrophy. Read More
Lundbeck’s Vyepti (eptinezumab-jjmr), a monoclonal antibody approved for the treatment of migraines, was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache, the company said. Read More
Citius Pharmaceuticals claimed a topline win in its pivotal phase 3 trial of I/Ontak (E7777) in patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). Read More