Makena

Type: Product
Name: Makena
First reported Aug 29 2014 - Updated Aug 29 2014 - 1 reports

Therapeutic Focus 2014: Women's Health

For those who want to get a hold on current trends in the treatment of women's health conditions, one place to look for guidance is, well, the past.Take the birth control category as an example. Owing to improved safety and the endorsement of medical ... [Published Medical Marketing And Media - Aug 29 2014]
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Lipocine Is A Compelling Investment Opportunity With Impending Phase 3 Data

Summary Lipocine is a specialty pharmaceutical company with a novel drug delivery technology for application in men’s and women’s health. The company’s lead product, LPCN 1021, is an oral testosterone replacement therapy (TRT) in a Phase 3 pivotal trial ... [Published Seeking Alpha - Aug 19 2014]
First reported Jul 08 2014 - Updated Jul 08 2014 - 1 reports

KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style

By Kurt R. Karst –The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone ... [Published FDA Law Blog - Jul 08 2014]

Quotes

...The FDA is requiring that "co-primary efficacy endpoint should show statically significant and clinically relevant differences" . The company plans on filing an NDA by the end of 2014...

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Therapeutic Focus 2014: Women's Health [Published Medical Marketing And Media - Aug 29 2014]
Lipocine Is A Compelling Investment Opportunity... [Published Seeking Alpha - Aug 19 2014]
KV Lawsuit Involving MAKENA and Compounded 17p ... [Published FDA Law Blog - Jul 08 2014]
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KV Lawsuit Involving MAKENA and Compounded 17p ... [Published FDA Law Blog - Jul 08 2014]
By Kurt R. Karst –The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone ...
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