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Companies focus on hard science, long-term pay-off at stem cell meeting

 
• By Mandy Jackson

Just because the science is hard that doesn't mean that biotechnology firms won't conduct pioneering regenerative medicine research or that major pharmaceutical companies won't invest in cell therapies. Regulatory approval for new products and health care payer reimbursement for innovative treatments also are possible despite the novelty of the field.

Just because the science is hard that doesn't mean that biotechnology firms won't conduct pioneering regenerative medicine research or that major pharmaceutical companies won't invest in cell therapies. Regulatory approval for new products and health care payer reimbursement for innovative treatments also are possible despite the novelty of the field.

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• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

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MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By Joseph Haas

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In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
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Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Gilead Set To Expand Trodelvy/Keytruda Into Frontline TNBC

 
• By Alaric DeArment

The company reported positive topline results for ASCENT-04, which also bode well for the ASCENT-03 trial in patients with low PD-L1 expression.