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Celera Group

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Latest From Celera Group

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

United States Pink Sheet Perspectives

FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App

The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.

Regulation Policy

Five (Non-COVID) Clinical Trial Misses Of 2021

The coronavirus pandemic may have dominated the news in 2021, but industry’s more bread and butter R&D activities continued. Here, Scrip takes a look at five of the more notable clinical trial misses of the year that got readers clicking. 

Clinical Trials Companies

Finance Watch: Mega-Rounds Add Up To Another Record Year For Biopharma VC Funding

Private Company Edition: NVCA and Pitchbook data show pharma and biotech companies raised $37.8bn in venture capital in 2021, up 41% from the record $26.8bn total in 2020. Recent mega-rounds include $190m for Maze and $200m for Alumis, and Sound Bioventures raised a €110m fund.

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