Regulatory
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
There appears to be some evidence that the agency is cracking down in general, although there’s debate among analysts about what exactly is going on.
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.
A briefing document from the U.S. FDA cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with osteoarthritis.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 23, 2021.
Although the beginning of March was fairly slow, the end of the month shows a busy schedule for PDUFA dates for the U.S. FDA. Read on to see what’s on the calendar for this week.
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
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