
Articles
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3 weeks ago |
biocentury.com | Selina Koch
ARTICLE | FinanceSV Health Investors’ Jonathan Behr on speeding development through precision strategies — and managing risk across a dementia-focused portfolio By Selina Koch, Executive EditorIn a challenging period for biotech’s specialist investors, the recent announcement that SV Health Investors’ Dementia Discovery Fund had closed a second fund stands out as a bright spot — especially given the historically perceived high risk of a dementia-focused strategy.
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1 month ago |
biocentury.com | Selina Koch
ARTICLE | RegulationBiotech’s regulatory odyssey in Barth syndrome exemplifies the problems Makary has vowed to fix By Steve Usdin, Washington EditorFDA has issued a complete response letter for elamipretide, sending patients with Barth syndrome, along with the drug’s developer, Stealth Biotherapeutics, careening around another unexpected turn on the regulatory rollercoaster.
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1 month ago |
biocentury.com | Selina Koch
ARTICLE | Editor's CommentaryFragmented systems limit Europe’s launch appeal — but targeted, regional actions could strengthen its position, help preserve access to innovation By Selina Koch, Executive EditorInvestors breathed a sigh of relief when last week’s MFN executive order appeared too vague to advance. But make no mistake: drug price controls remain a U.S. political priority.
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1 month ago |
biocentury.com | Selina Koch
ARTICLE | RegulationThe FDA commissioner says he’ll retain existing structure, which will require recruiting staff to fill critical positions By Steve Usdin, Washington EditorFDA Commissioner Marty Makary has rejected a staff proposal to reorganize the agency, he said in a recent interview. The proposed reorganization, which circulated widely on Capitol Hill, alarmed former FDA leaders and biopharma CEOs who predicted that it would render the agency dysfunctional.
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2 months ago |
biocentury.com | Selina Koch
ARTICLE | Product DevelopmentAn advancing wave of new candidates, spanning diverse modalities, converges with push for surrogate endpoint status By Selina Koch, Executive EditorIs tau the new amyloid? Leaders in the Alzheimer’s field have high conviction in tau — both as a target and surrogate endpoint — and they aren’t letting a string of clinical misses deter them. Sound familiar?
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