The judicial microscope on abortion meds puts FDA and industry in a precarious spot
PharmaVoice
by Meg Alexander
2h ago
The recent SCOTUS case involving mifepristone exposes the risk of drug safety determinations by judicial fiat ..read more
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Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown
PharmaVoice
by Michael Gibney
2h ago
The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi ..read more
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Using the body as ‘a bioreactor’ — a regenerative medicine expert on where the field is headed
PharmaVoice
by Alexandra Pecci
2h ago
The director of the University of Pittsburgh’s McGowan Institute for Regenerative Medicine believes the industry is “turning a corner ..read more
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FDA’s new diagnostic rules draw pharma criticism
PharmaVoice
by Amy Baxter
3d ago
Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions ..read more
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As drug shortages reach record highs, regulators float next steps
PharmaVoice
by Kelly Bilodeau
3d ago
With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies ..read more
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Takeover target? Activist investor believes Novavax tech would be in ‘better hands’ with Big Pharma
PharmaVoice
by Meagan Parrish
6d ago
With its next earnings report looming, pushback from an investor is adding pressure on Novavax to boost performance ..read more
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$4M+ gene therapies? How payers can adapt to a new reality of pricey ‘cures’
PharmaVoice
by Michael Gibney
1w ago
Pricey gene therapies promise great benefit to patients but pose a threat to the payer landscape — ICER and a Tufts think tank are offering potential solutions ..read more
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As AI proliferates in pharma, regulators look to catch up in clinical trials
PharmaVoice
by Amy Baxter
1w ago
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance ..read more
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4 offbeat biotechs making a splash in the life sciences
PharmaVoice
by Alexandra Pecci
1w ago
From resurrecting an extinct species to improving regenerative medicines with plant-based materials, these biotechs are on the leading edge of science ..read more
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Now a biopharma powerhouse, Vertex’s R&D bedrock could deliver tomorrow’s blockbusters
PharmaVoice
by Michael Gibney
1w ago
From its landmark CRISPR approval to its potential breakthrough drug for pain, Vertex’s development approach, led by chief scientific officer Dr. David Altshuler, is paying off ..read more
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