Drug Development
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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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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.
According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.
Bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension.
Pfizer’s COVID-19 vaccine data has once again been threatened by hackers. The alleged theft of intellectual property has been laid at the feet of North Korea’s government.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.
The WHO’s Emergency Use Listing (EUL), a prerequisite for COVAX Facility vaccine supply, evaluates the safety, quality, and efficacy of the COVID-19 vaccines. As such, today’s approval allows the vaccine to be used by agencies and NGOs around the world.
The combination of Keytruda and Lenvima was compared to Lenvima plus everolimus versus Pfizer’s Sutent (sunitinib) for first-line treatment of patients with advanced renal cell carcinoma (RCC).
Early results from University of Oxford’s RECOVERY trial showed Roche’s immunosuppressant Actemra reduced deaths and the need for mechanical ventilation in severe COVID patients.
After announcing topline data from two identical Phase III trials, Roche’s Genentech has doubled down on data and are now showing positive results from four studies for its newest blindness-fighting treatment.
It was a busy week for clinical trial announcements and news. Here’s a look.