| | | |   | The time has come for our annual celebration of early-career researchers doing remarkable things. The 2022 iteration of STAT Wunderkinds is officially accepting nominees, and you can submit the promising scientist in your life by clicking here. | | | Cel-Sci’s selective hotline Federal law is pretty clear on the fact that, if you’re a public company with stock-moving news on the horizon, you have to tell everyone at the same time so that privileged traders can’t get an unfair advantage. That makes Cel-Sci’s decision to use an invite-only call to promote a “major press release” in the near future potentially problematic.
STAT’s Adam Feuerstein was on the call, where CEO Geert Kersten told a select group of investors and brokers about Cel-Sci’s upcoming disclosure on its cancer drug, called Multikine. It will coincide with the publication of data from Multikine’s failed Phase 3 trial in head and neck cancer, Kersten said.
Those data will be “basically incomprehensible for most people” who aren’t “statisticians and physicians,” Kersten said. The aforementioned press release, however, will be “easy to understand without dumbing it down too much,” Kersten said, “written in a way that will satisfy both.”
Read more. | The latest reading material for FDA tea leaves After a spate of unexpected roadblocks for drugs seeking FDA approval, the fate of Axsome’s treatment for depression could offer clues on just how strict the agency has become.
Any day now, the FDA could make a final decision on Axsome’s long-delayed application for AXS-05, a drug for major depressive disorder. AXS-05 was first up for approval last August, but the FDA found “deficiencies” in its application, the company said, leading to two delays. According to Axsome, the company addressed those questions and, in January, the FDA acknowledged receipt of its answers. That means, if the agency follows its three-month schedule for amended applications, a final decision could come this month.
Axsome is one of nearly a dozen companies that have received so-called deficiency letters in the past 12 months, most of which have come on the eve of expected FDA approvals. Nearly all of them have resulted in rejections, and an approval for AXS-05, however delayed, could marginally improve sentiment in biotech. | Pharma at the intersection of private enterprise and public interest The pharmaceutical industry is global, highly competitive, and tightly regulated. As its challenges and opportunities grow, so does its need for professionals who fully understand the legal, business, and scientific considerations involved in the drug development process. Learn how tomorrow’s pharma leaders can gain that expertise with a Master of Science in Law: Life Sciences degree. | Another novel painkiller comes up short Acadia Pharmaceuticals’ investigational pain treatment failed to outperform placebo in a study enrolling patients recovering from foot surgery, marking the latest disappointment in the drug industry’s yearslong search for non-addictive painkillers.
Two dosages of the drug, ACP-044, proved no better than placebo at reducing patient-reported pain scores within 24 hours of bunionectomy, the company said yesterday. Acadia plans to “analyze the totality of the data” before deciding whether to continue developing ACP-044 as a treatment for acute pain. The company is running a clinical trial testing whether the drug can relieve chronic pain due to osteoarthritis.
Acadia’s failed trial adds to years of disappointing attempts to develop novel medicines that can outperform old painkillers without the risks brought by opioids. Among the lone bright spots was last month's news that Vertex Pharmaceuticals' experimental pill succeeded in two studies focused on acute pain following surgery. Vertex plans to advance its drug into pivotal studies in the second half of this year, pending permission from the FDA. | Will we ever get better Covid-19 vaccines? The near-miraculous speed of development for Covid-19 vaccines has saved lives around the globe and set a new standard for scientific discovery. With viral mutations making those vaccines less and less effective, can society get its act together and do it all over again?
That’s among six nagging mysteries at this stage of the pandemic, as outlined by a team of STAT reporters. The answer, for vaccines, involves a complicated interplay of political will, market incentive, and scientific inspiration.
The short answer is that, as with Operation Warp Speed, society is likely to get new vaccines if it’s willing to move heaven and earth in the name of their development. What remains unclear is whether any of 2020’s clarity has endured in 2022.
Read more. | More reads - Imara to reduce staff by 83% amid biotech shakeout. BioPharma Dive
- McKinsey opened a door in its firewall between pharma clients and regulators. New York Times
| Thanks for reading! Until tomorrow,  | | | |
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