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Covis Group Completes Acquisition of AMAG Pharmaceuticals
Covis Group S.à r.l. ("Covis") today announced the completion of its acquisition of AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) 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. The combined organization will operate as part of the Covis Pharma Group and will be led by Covis CEO Michael Porter.
PR Newswire · 11/16/2020 14:20
Statement by Minister Chagger on Diwali
Today, members of Hindu, Jain, and Buddhist communities in Canada and around the world celebrate DiwaliOTTAWA, ON, Nov. 14, 2020 /CNW/ - Today, members of Hindu, Jain, and Buddhist communities in Canada will celebrate Diwali—also known as the Festival of Lights.
CNW Group · 11/14/2020 14:30
AMAG Pharmaceuticals (AMAG) Earnings Expected to Grow: Should You Buy?
AMAG Pharmaceuticals (AMAG) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Zacks · 10/30/2020 17:30
The Daily Biotech Pulse: Vertex Pulls Plug On Protein Deficiency Drug, FDA Nod For Regeneron's Ebola Treatment, Can Fite Issues Psoriasis Readout
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 14)
Benzinga · 10/15/2020 12:03
Covis Group S.à r.l. Announces Commencement Of Tender Offer For All Outstanding Shares Of AMAG Pharmaceuticals, Inc.
LUXEMBOURG and ZUG, Switzerland, Oct. 15, 2020 /CNW/ -- Covis Group S.à r.l. ("Covis") announced the commencement of a cash tender offer to purchase all of the outstanding shares
Benzinga · 10/15/2020 11:32
AMAG Pharmaceuticals Requests Hearing to Maintain Makena® (Hydroxyprogesterone Caproate Injection) as a Treatment Option for Clinically Indicated Pregnant Patients
WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- 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) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed. Today’s hearing request will be followed by a submission of supporting documentation to the FDA. That submission will provide further detail on the company’s reasoning for a hearing, recognizing clinicians’ decade-long use of this treatment and the public health implications of withdrawing its approval. At this time, it is important to note that Makena remains approved and available and the product label remains unchanged.“We believe it is in the best interest of these high-risk pregnant patients to allow their obstetrical provider to determine whether to use Makena, following the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) guidelines, as well as their own long-standing clinical experience. The continued widening of maternal and infant health disparities among minority and disadvantaged communities, and the potential return to compounded versions of Makena are concerning,” said AMAG CEO Scott Myers. “We remain committed to preserving access to the FDA-approved therapy, as there are no other evidence-based options for these vulnerable patients.”AMAG submitted a proposal earlier this year to the FDA, requesting to meet and discuss two studies intended to define the patient population who would most benefit from therapy: a retrospective study using real world evidence, and a prospective, primary data collection study. FDA declined the request to meet, stating it was premature. AMAG announced in August that it was beginning the first part of the retrospective study.Covis Pharma has entered into a transaction to acquire AMAG, which is subject to customary closing conditions including the tender offering and is expected to close in November.Commenting on AMAG’s hearing request, Covis Pharma CEO Michael Porter said, “We support the efforts by AMAG to preserve patient access to this important treatment option. AMAG and Covis believe in Makena’s efficacy for those at risk for recurrent preterm birth, which are often vulnerable patient groups. We respectfully believe that further study is necessary before precipitously withdrawing the product from the market and are prepared to help formulate and implement appropriate study parameters for additional review of its efficacy.”ACOG issued a statement in response to FDA’s proposed withdrawal, noting that the need for an effective preterm birth treatment is great. As ACOG further recognized, Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition. ACOG states that their treatment recommendations remain unchanged at this time.ABOUT AMAG AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.Forward Looking Statements This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding plans to submit, and expectations for, supporting documentation to the FDA; beliefs that it is in the best interest of patients to allow access to Makena; beliefs about maternal and infant health disparities among minority communities and the return to compounded versions of Makena, and that there are no other evidence-based options; beliefs, including beliefs attributed to other groups, in Makena’s efficacy for those at risk, including that further study should be undertaken into the efficacy of Makena before taking action to withdraw the product from the market and the ability of AMAG’s efforts to preserve patient access to Makena; expectations for working towards formulating and implementing appropriate study parameters to be undertaken to confirm Makena’s efficacy after the tender offer and merger transaction between Covis and AMAG closes, and expectations for the recently announced tender offer and merger transaction are based on management’s current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.Such risks and uncertainties include, among others, risks and uncertainties related to the path forward for Makena and our ability to successfully and timely secure a hearing and compile information that might be helpful to the FDA; the possibility that our request for a hearing could be denied, or that the FDA will withdraw marketing approval for Makena even following such a hearing (or before or during the pendency of the hearing and deliberation), the pursuit and planning of which could be costly and distracting to management, the risks related to the pending tender offer and merger transaction (including as described in our Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on October 1, 2020), and those other risks identified in AMAG’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2019 (as amended), its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarters ended March 31, 2020 and June 30, 2020, and in any subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.AMAG CONTACT: Investors & Media: Rushmie Nofsinger (617) 498-2806
GlobeNewswire · 10/14/2020 21:11
AMAG Pharma Reports Request For Hearing To Maintain Makena As Treatment Option For Clinically-Indicated Pregnant Patients
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
Benzinga · 10/14/2020 20:11
Merger Arbitrage Mondays - Bristol Myers Squibb And Morgan Stanley Are Back At It
Merger activity decreased last week with four new deals announced.The acquisition of MyoKardia by Bristol Myers Squibb Company.The acquisition of Eaton Vance by Morgan Stanley.
Seekingalpha · 10/12/2020 13:09
Merger Arbitrage - Q3 2020 Ends With A Big Bang
Merger activity increased significantly last week with ten new deals announced.The merger of WPX Energy (WPX) and Devon Energy Corporation (DVN).Morgan Stanley (MS) completes the acquisition of E*TRADE Financial Corporation (ETFC).
Seekingalpha · 10/09/2020 04:58
Kodiak Initiates Phase 3 Trial, And Other News: The Good, Bad And Ugly Of Biopharma
Kodiak Sciences reports initiation of Phase 3 trial of KSI-301.Incyte announces peptide-centric strategic collaboration with Nimble.AMAG receives a setback as the FDA rejects Makena.
Seekingalpha · 10/08/2020 06:52
The Daily Biotech Pulse: Pfizer, BioNTech Begin European Filing For Coronavirus Vaccine, Y-mAbs BLA Rejected, GlycoMimetics Granted Rare Pediatric Disease Designation
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 5)
Benzinga · 10/06/2020 12:24
AMAG Pharmaceuticals Provided Update on FDA's Proposal Regarding Makena; Says has 15 Days to Respond to FDA; Continues to Expect Its Recently Announced Tender Offer and Merger to Close in November 2020
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced that it received a notice from the U.S.
Benzinga · 10/06/2020 09:40
FDA provides further update on Amag Pharma's Makena approval
AMAG Pharmaceuticals (AMAG) has received FDA notification that the Agency is proposing to withdraw approval of Makena (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who
Seekingalpha · 10/06/2020 05:32
Amag Pharma mulling options related to Makena withdrawal
AMAG Pharmaceuticals (AMAG) has received FDA notification that the Agency is proposing to withdraw approval of Makena (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who
Seekingalpha · 10/06/2020 05:32
AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)
* The product remains on the market * AMAG has 15 days to respond to the FDA * AMAG continues to expect its recently announced tender offer and merger to close in November 2020 WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it received
GlobeNewswire · 10/06/2020 01:05
FDA to yank approval for Amag Pharma's Makena; shares down 6%
In a not-unexpected move, the FDA is proposing that AMAG Pharmaceuticals' ([[AMAG]] -6.0%) Makena (hydroxyprogesterone caproate injection), approved in the U.S. in February 2011 to reduce the risk of preterm
Seekingalpha · 10/05/2020 18:00
AMAG (AMAG) to be Acquired by Covis Group for $647 Million
AMAG (AMAG) is set to be acquired by Covis Group for approximately $647 million.
Zacks · 10/05/2020 15:04
NOTICE - IMPORTANT SHAREHOLDER INVESTIGATION UPDATE: Brodsky & Smith, LLC Reminds Investors of Investigations Related to the Following Companies: SINA Corporation (Nasdaq - SINA), AMAG Pharmaceuticals, Inc. (Nasdaq-AMAG), BMC Stock Holdings, Inc. (Nasdaq - BMCH)
BALA CYNWYD, PA / ACCESSWIRE / October 2, 2020 / Brodsky & Smith, LLC reminds investors of investigations it is conducting regarding the following companies for possible breaches of fiduciary duty and other violations of federal and state law with respect to proposed acquisition transactions.
ACCESSWIRE · 10/02/2020 23:50
MERGER ALERT AMAG and STND: Levi & Korsinsky, LLP Reminds Investors of Investigations Concerning the Mergers of these Companies
NEW YORK, NY / ACCESSWIRE / October 2, 2020 / The following statement is being issued by Levi & Korsinsky, LLP:Levi & Korsinsky, LLP announces that investigations have commenced on behalf of shareholders of the following publicly-traded companies.
ACCESSWIRE · 10/02/2020 22:55
The Daily Biotech Pulse: Mesoblast Slumps On FDA Rejection, AstraZeneca's Breakthrough Therapy Designation, 3 IPOs
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 1)
Benzinga · 10/02/2020 11:35
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About AMAG
AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company's segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth.