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The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
Job Trends
While hiring activity has not yet picked up, it should do so soon, according to BioSpace Recruitment Manager Greg Clouse. Meanwhile, another year-over-year decrease in layoffs means less competition for jobs.
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Lilly CEO Dave Ricks in Wednesday’s third-quarter earnings call acknowledged that the company is at the mercy of wholesaler stocking decisions.
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“We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.
NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.
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.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the protein the therapy replaces.
After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.
While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug in a prior multiple sclerosis study.
After GSK subsidiary Tesaro filed a lawsuit Thursday claiming that AnaptysBio breached “certain requirements” under their 2014 license agreement involving GSK’s Jemperli, Anaptys responded Friday morning.