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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.

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.

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.

HBW Insight

Bayer Leads Push For Self-Care In India As Local Business Launches

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Bayer has launched a dedicated Consumer Health business in India to market products in key OTC categories. The company is also working to bring different stakeholders together through the creation of a new organization dedicated to promoting self-care in the South Asian country.

HBW Insight

New York’s Age Restrictions On Weight Loss, Sports Supplement Sales Fail To Fly

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New York legislation to restrict sales of weight loss and sports nutrition supplements to minors failed without reaching a vote before the end of the session. But the proposal will continue to be a challenge for industry in New York as well as around the country.

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