AMAG Pharmaceuticals

374 articles with AMAG Pharmaceuticals

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  Big Bank Analyst Charged by SEC for Insider Trading Ahead of Biopharma Deals

  9/30/2021

  Jose Luis Casero Sanchez took advantage of his position in Goldman Sachs’ “control room” to gain insider knowledge of upcoming transactions, including those for several biopharma companies.
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  FDA Grants Public Hearing for Makena Injection Amidst Controversy

  8/20/2021

  Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.

• AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection)

  12/14/2020

  AMAG Pharmaceuticals, Inc. has submitted its response to the FDA’s Notice of Opportunity for a Hearing (“NOOH”) regarding the Agency’s proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

• Covis Group Completes Acquisition of AMAG Pharmaceuticals

  11/16/2020

  Covis Group S.à r.l. announced the completion of its acquisition of AMAG Pharmaceuticals, Inc. through the successful tender offer for all of the outstanding shares of common stock of AMAG at $13.75 per share in cash and subsequent merger.

• Covis Group S.à r.l. Announces Commencement of Tender Offer for All Outstanding Shares of AMAG Pharmaceuticals, Inc.

  10/15/2020

   Covis Group S.à r.l. ("Covis") announced the commencement of a cash tender offer to purchase all of the outstanding shares of common stock of AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) ("AMAG"). The tender offer is being made pursuant to the merger agreement (the "Merger Agreement") announced by Covis and AMAG on

• AMAG Pharmaceuticals Requests Hearing to Maintain Makena® (Hydroxyprogesterone Caproate Injection) as a Treatment Option for Clinically Indicated Pregnant Patients

  10/14/2020

  AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena ® , the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al . A second, FDA-required trial ( PROLONG ) predominant

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  FDA Intends to Withdraw Approval of Only Treatment for Reducing Preterm Birth

  10/7/2020

  Makena, the only FDA-approved treatment to reduce preterm birth failed to meet endpoints in a recent trial. The FDA gave notice of intent to withdraw approval.

• AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)

  10/6/2020

  AMAG Pharmaceuticals, Inc. announced that it received a notice from the U.S. Food and Drug Administration that the FDA is proposing to withdraw approval of Makena®, a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth.

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  Covis Group to Acquire AMAG Pharmaceuticals in $647 Million Deal

  10/2/2020

  “AMAG’s category-leading treatments are strong strategic complements to our existing therapeutic portfolio,” said Michael Porter, Covis’ chief executive officer.

• Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals

  10/1/2020

  Addition of AMAG’s category leading treatments positions Covis to become a global market leader of therapeutic solutions for life-threatening conditions and chronic illnesses Covis will commence a tender offer to acquire all the outstanding shares of AMAG for a purchase price of $13.75 per share in cash, or approximately $ 647 million, including debt obligations expected to be assumed or repaid net of cash Transaction expected to close in November 2020 post tender offer LUXEMBO

• AMAG Pharmaceuticals to Participate in H.C. Wainwright 22nd Annual Global Investment Conference

  9/9/2020

  AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Scott Myers, Chief Executive Officer, and Brian Piekos, Chief Financial Officer, will participate in a fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 a.m. Eastern Time.

• AMAG Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Corporate Update

  8/6/2020

  AMAG Pharmaceuticals, Inc. reported unaudited consolidated financial results for the second quarter ended June 30, 2020.

• AMAG Pharmaceuticals to Host Second Quarter FY 2020 Financial Results Conference Call and Webcast on Thursday, August 6, 2020

  7/28/2020

  AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its second quarter 2020 financial results will be released on Thursday, August 6, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments. Dial-in Number U.S./Canada Dial-in Number: (877) 412-6083 International Dial-in Number: (702) 495-1202 Confe

• Palatin Technologies Announces Mutual Termination of License Agreement with AMAG Pharmaceuticals for Vyleesi®

  7/27/2020

  Palatin Technologies, Inc. announced that it has mutually terminated the January 2017 license agreement which granted AMAG Pharmaceuticals exclusive North American rights to market Vyleesi®, the first and only on demand treatment for pre-menopausal women suffering from acquired, generalized, hypoactive sexual desire disorder, a condition affecting one in ten premenopausal women.

• AMAG Pharmaceuticals Completes Divestment of Women’s Health Assets

  7/27/2020

   AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced AMAG and Palatin Technologies, Inc. have mutually terminated the January 2017 license agreement pursuant to which AMAG was granted exclusive rights to develop and commercialize Vyleesi® (bremelanotide), a melanocortin receptor agonist indicated for th

• AMAG Pharmaceuticals and Norgine B.V. Enter Into Exclusive Licensing Agreement to Commercialize Ciraparantag in Europe, Australia and New Zealand

  7/23/2020

  Agreement provides AMAG with $30 million upfront payment and eligibility to receive up to $260 million in development and commercial milestones in addition to sales royalties

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  Clinical Catch-Up: July 13-17

  7/20/2020

  It was a surprisingly big week for clinical trial updates related to COVID-19, although there was plenty of non-COVID-19 news as well. Here’s a look.

• AMAG Announces Presentation of Ciraparantag Data at the International Society on Thrombosis and Haemostasis

  7/12/2020

  Data from two Phase 2 randomized, placebo-controlled, dose-ranging studies using ciraparantag demonstrate efficacy and safety in the reversal of apixaban and rivaroxaban

• AMAG Pharmaceuticals Announces Leadership Changes

  6/11/2020

  AMAG Pharmaceuticals, Inc. announced that Edward Myles, Chief Financial and Chief Operating Officer, is leaving the Company.

• AMAG Pharmaceuticals to Participate in Jefferies 2020 Virtual Global Healthcare Conference

  5/27/2020

  AMAG Pharmaceuticals, Inc. announced that management will participate at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 4:00 p.m. Eastern Time.