Foghorn's mounting deaths trigger FDA full hold
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Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline

Alcon is buying in pipeline prospects to support its expansion into the eye drug market, striking a $770 million takeover of Aerie Pharmaceuticals to add two approved therapies and a clutch of investigational treatments for retinal and ocular surface diseases.

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Top Stories

Moderna co-founder helps finance Belgian mRNA shop

Moderna co-founder Kenneth Chien is staying close to budding mRNA-based biotechs, investing in eTheRNA's latest 39 million euro series B. As a result, he'll join the company's board, alongside fellow investor and VC founder Marijn Dekkers.

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Foghorn downgraded to full clinical hold, with more patient deaths clouding AML, MDS trial

Three months after the FDA sent a warning to Foghorn via a partial clinical hold on its phase 1 trial, regulators have become even more dismayed, downgrading the company's study to a full hold in light of additional patient deaths. 

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Merck, seeking XI factor in race with Bayer, gets FDA fast-track tag for anticoagulant

The FDA has delivered a boost to Merck’s mission to provide a standard of care anticoagulation therapy for end-stage renal disease (ESRD) patients by slapping a fast-track tag on midphase asset MK-2060.

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Windtree takes weight off branches, enters near $80M biobucks deal for acute pulmonary pipeline platform

Windtree Therapeutics is taking weight off its branches, entering a global licensing deal with Lee’s Pharmaceutical and Zhaoke Pharmaceutical that offers more than $78.9 million in potential biobucks for several acute pulmonary pipeline treatments.

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Not all cancer associated fibroblasts are created equal—some promote, some suppress drug resistance

Cancer-associated fibroblasts are commonly believed to induce drug resistance. But when researchers at Moffitt Cancer Center took a closer look at the fibroblasts, they discovered that while some induce drug resistance, some induce drug sensitivity.

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Alpha Cognition's delayed-release Alzheimer's drug hits goal, teeing up approval filing

Alpha Cognition has taken another step toward a filing for approval of its delayed-release treatment for Alzheimer’s disease, publishing top-line results from a study that compared the prospect to an incumbent product.

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Compliance with Oct. 6 data blocking regulations will suffer without more clarity, stakeholders tell HHS

Scenario-specific FAQs, clearer definitions and technical assistance will go a long way toward helping providers meet new info blocking regulations slated for Oct. 6, stakeholders including Ascension, Epic, Mayo Clinic, AMIA and the HIMSS told HHS.

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Digital Diagnostics dials up $75M funding for diabetic retinopathy AI

Not long after forging a partnership with Baxter earlier this year, Digital Diagnostics has roped in $75 million in series B funding to build out the reach of IDx-DR and its other AI-powered diagnostic tools, the company announced Tuesday.

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UPDATED: Teva won't reopen troubled California site, where 300-plus are losing their jobs

Teva Parenteral Medicines is letting go of 305 staffers at its site at 19 Hughes, Irvine, California, according to a local Worker Adjustment and Retraining Notification Act notice. In a statement, the company said it's moving to close the troubled site.

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Judge rules CMS unfairly overturned Georgia's Medicaid work requirements program

A federal judge sided with Georgia that CMS unfairly struck down the state's Medicaid work requirements program, saying that the decision was arbitrary.

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GSK claps back at Teva in 'skinny' label case, arguing verdict doesn't threaten companies who act 'properly'

GSK has urged the U.S. Supreme Court to reject Teva's petition to reopen its patent infringement case over blood pressure drug Coreg. Teva argues that the verdict could have dire consequences for the generics industry and its ability to use "skinny" labels.

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