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Cytyc Corp.

Division of Hologic Inc.
www.cytyc.com

Latest From Cytyc Corp.

AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

Advisory Committees Post Market Regulation & Studies

Did Biogen's Kingsley Take Blame For Tecfidera Sales?

The timing of Biogen's Oct. 9 announcement that Tony Kingsley, executive vice president of global commercial operations, is leaving the company came at an unfortunate time – just weeks before third quarter earnings will reveal whether Tecfidera (dimethyl fumarate) sales are growing, stable or sliding.

Infectious Diseases Neurology

Medtech Start-Ups Innovate In Minimally Invasive Gynecology

Medtech start-ups are taking on the global endometrial ablation and uterine artery embolization markets with next-generation systems designed to raise the standard of care in menorrhagia treatment. Profiles of Channel Medsystems, EmboMedics, and Minerva Surgical.

Medical Device

Makena’s Orphan Exclusivity Is “Nullified” By FDA’s Compounding Policy, KV Suit Says

KV seeks a court order requiring FDA to desist from permitting importation of unapproved API for compounded hydroxyprogesterone and to state its intent to take enforcement action against compounders.

BioPharmaceutical Legal Issues
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