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10 March, 2026 |
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sponsored by
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Built for Speed: Integrated Early‑to‑Late Phase CDMO Solutions
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| Avid Bioservices delivers solution‑focused capabilities and the capacity biopharma innovators need to advance programs with confidence. Our new Early Phase Center of Excellence, centrally located in Costa Mesa, California, provides rapid, flexible support for early development with a direct, seamless transition into our late‑stage and commercial manufacturing facility. This integrated approach reduces handoffs, accelerates timelines, and helps keep your therapy moving efficiently toward patients.
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The FDA is once again reviewing Capricor’s cell therapy for Duchenne muscular dystrophy after rejecting the treatment last summer. Capricor has since submitted positive data from a Phase 3 trial, and a review decision is now expected in August. |
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Alexis Kramer |
Editor, Endpoints News
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Charl van Zyl, Lundbeck CEO |
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by Zachary Brennan
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With scant data, HHS Secretary Robert F. Kennedy Jr. said last month that Europeans were already paying higher drug prices thanks to more than a dozen secret agreements the White House forged with the biopharma industry. But the effects of the so-called "most favored nation" deals, which cut certain prices under Medicaid to levels similar to some European countries, aren't being felt across the Atlantic quite yet, Charl van Zyl, CEO of the Copenhagen-based pharma company Lundbeck, told Endpoints News in an interview Tuesday. While noting that Lundbeck won't be forging its own MFN deal with the White House, he said the company could end up participating in one of the CMS pilots — GLOBE and GUARD. | |
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PhD student Janice Pang (L) and University of Toronto biologist Omar Khan (R) created synthetic lncRNA molecules (Tim Fraser, KITE Studio) |
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by Ryan Cross
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In the latest addition to the growing cornucopia of ideas for how to turn RNAs into medicines, scientists are now developing synthetic versions of a historically overlooked molecule that could unlock a new class of drugs. These molecules, known as long non-coding RNAs, are important for controlling how genes are
regulated. They outnumber the more well-studied protein-coding genes nearly two-to-one, yet there's been comparatively little research on them. That discrepancy has always bothered Omar Khan, an RNA biologist at the University of Toronto. Now he has shown that three lncRNAs previously known to control immune system genes can reduce inflammation when administered to human cells and in mice. | |
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by Tom Randall, Jared Whitlock
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Gene therapies were supposed to be competition-proof. They are scientifically complex, require bespoke manufacturing, often go after small patient populations and can cost millions per dose. But that assumption is being tested by a wave of competitors being developed in China — with prices starting at a fraction
of what's currently available in the US. An Endpoints News analysis looked at the world's 10 most expensive gene therapies and found 77 competitors in development around the world. Of those, 48 are from China — more than double the number under development in the US, and 7 times what's being worked on in Europe.
The development of these gene therapies is the latest piece of evidence that China is competing higher and higher on the spectrum of innovative science.
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by Elizabeth Cairns
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Uğur Şahin and Özlem Türeci are set to leave BioNTech by the end of the year and es |
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