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AMAG Pharmaceuticals Inc.

www.amagpharma.com

Latest From AMAG Pharmaceuticals Inc.

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

US FDA’s Higher Bar For Postmarketing Pregnancy Studies Shown By AMAG’s Vyleesi, Sprout’s Addyi

Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.

Drug Approval Standards Drug Safety

AMAG Must Build Market For Approved Female Libido Drug To Avoid Addyi’s Fate

AMAG Pharmaceutical’s HSDD drug Vyleesi, has been approved by the FDA. But analysts warn it must build the market in women who may not be aware they have a condition if it is to fare better than Sprout’s Addyi.

Approvals Gynecology & Urology
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