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Johnson & Johnson

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Latest From Johnson & Johnson

What’s At Stake As China Expands '4+7' Scheme: An Infographic Snapshot

China’s massive centralized "4+7" drug procurement scheme is now being rolled out nationwide, involving some of the largest provincial markets and huge product volumes.

China Policy & Regulation

J&J's Erleada Approved By FDA In New Prostate Cancer Indication

Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.

Cancer Approvals

NDAC Recommendation To Approve GSK's Mouth Spray NRT Comes With Caveats

No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.

International United States

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

OTC Drugs FDA
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