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AMAG Pharmaceuticals Inc.

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Latest From AMAG Pharmaceuticals Inc.

Makena Panel Vote Adversely Influenced By Framing Of Withdrawal Question, Covis Says

‘Ad hoc narrowing’ of the final voting question by hearing officer Celia Witten prevented adcomm members from voting on Covis’ proposal to restrict the preterm birth prevention drug's indication while further study was conducted, company says.

Review Pathway Post Market Regulation & Studies

End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’

Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.

Post Market Regulation & Studies Review Pathway

China Approves Two More Home-Grown COVID-19 Antivirals

Top-line results for two newly approved COVID-19 antivirals in China showed roughly 1.5- to two-day cuts in median time to symptom resolution or recovery in mild-to-moderate Omicron patients versus placebo.

China Approvals

JPM 2023: Novocure Announces Trial Results; ResMed Expands Manufacturing; Abbott's IVD Bet Pays Off

The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies; Some use the conference as a platform for major announcements while some just take the opportunity to explain their 2023 outlook to investors. Here are some of the highlights from the presentations on the second day of the meeting.

Approvals Business Strategies
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  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Advanced Magnetics, Inc.
    • Cord Blood Registry (CBR)
    • Ethex Corporation
    • K-V Pharmaceutical Company (KV Pharmaceutical)
    • Lumara Health Inc.
    • Perosphere Inc.
    • Perosphere Pharmaceuticals
    • Ther-Rx Corporation
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