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AMAG Pharmaceuticals Inc.

www.amagpharma.com

Latest From AMAG Pharmaceuticals Inc.

Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues

Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.

Advisory Committees Drug Safety

Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.

Advisory Committees Review Pathway

Finance Watch: Gene Therapy, Targeted Oncology Driving IPOs Despite Biopharma Stock Shakiness

Public Company Edition: Jefferies report notes robust IPO market, but SVB Leerink predicts a financing slowdown. Also, Mirati raises cash for KRAS programs after Amgen's ASCO data and a strategic shift results in job cuts at ImmunoGen.

Financing Deals

CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate

CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.

Approvals Complete Response Letters
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