Drug Development
Ulotaront failed to meet primary endpoints in two studies. The companies said high COVID-19 placebo effect “may have masked molecule’s therapeutic effect” and plan to discuss next steps with the FDA.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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Alnylam revealed its Phase III APOLLO-B study, which showed that patisiran improves both functional capacity and quality of life in patients with ATTR amyloidosis with cardiomyopathy.
Roche signed a big $6 billion-plus collaboration deal with Poseida on blood cancers while its partner, AC Immune, parsed failed data on an Alzheimer’s drug to suggest a positive spin.
Although no new safety concerns were observed, Merck’s Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan.
While Moderna’s sole marketable program is its COVID-19 vaccine, CEO Stéphane Bancel said the company is “actively working to prepare...new product launches to help patients and drive growth.”
Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.
Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
The annual Alzheimer’s Association International Conference (AAIC) is running from July 31-August 4 at the San Diego Convention Center and online. Here are some of the highlights presented so far.
According to two recent studies, 10 to 30% of people with COVID-19 reported at least one persistent symptom up to six months after infection, which qualifies as Long COVID.
The exact implications of the paxalisib disappointment are still unclear, though it is highly likely that the candidate will be dropped from the GBM AGILE umbrella trial.