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Pink Sheet

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

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CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

Generics Bulletin

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

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After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

Medtech Insight

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

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With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

Citeline

Informa Pharma Intelligence Launches Citeline Study Feasibility to Accelerate Clinical Trial Timelines

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New platform will employ machine learning to provide clinical trial sponsors with crucial insights to model feasibility scenarios in seconds

Topic Clinical Trials Clinical Trial Optimization

Scrip

Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

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The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.

Medtech Insight

StrataGraft Topical Burn Treatment Gets US FDA Approval

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The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.

Citeline Study Feasibility

Minimizing Luck in Study Feasibility

Minimizing Luck in Study Feasibility

This informative whitepaper introduces you to best practices in study feasibility, which laid the groundwork for our new predictive analytic that is launching soon, Citeline Study Feasibility.  Our industry-leading technology will deliver advanced insight to improve your clinical trial decisions, fast-track enrollment and optimize cycle times – all with less effort.

Topic Clinical Trials

Scrip

Novavax’s Latecomer COVID-19 Vaccine Impresses With 90% Efficacy Result

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Arriving two to three months later than planned, Novavax’s nanoparticle-based vaccine is still a welcome addition to the field, for both rich and poor countries.

Scrip

Quick Listen: Scrip’s Five Must-Know Things

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In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

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