Noven Pharmaceuticals

Noven receives FDA new indication approval for Minivelle

Thursday, October 2, 2014 02:01 PM

Noven Pharmaceuticals has announced that the FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis.

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Noven initiates phase II study of investigational d-ATS for ADHD

Monday, October 8, 2012 08:00 AM

Noven Pharmaceuticals, a a specialty pharmaceutical company and wholly-owned subsidiary of Hisamitsu Pharmaceutical, has commenced a phase II study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

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December 22

DaVita combines its two research CRO units to create an end-to-end CRO focused on kidney, end-stage renal disease

New crop of clinical trial matching services use patient’s molecular, genomic data for better fit

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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