Amag's shares fall after $323M pregnancy drug fails in post-approval trial

Nearly a decade after an injectable drug called Makena, now owned by Amag Pharmaceuticals Inc., became the standard of care for pregnant women at risk for preterm delivery, a new study of the drug failed to back up the company's claims that it helps reduce premature births. In a 1,700-person clinical trial, about 11 percent of women who were administered the drug by Waltham-based Amag (Nasdaq: AMAG) delivered their babies 35 weeks into their pregnancy or earlier. That was not significantly better…
Source: Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news

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Chloe Wilkinson, 30, went into labour after just 24 weeks of being pregnant while travelling back from Australia with her partner, Patraic Walsh-Kavanagh.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Purpose of review Medical decision making and practices surrounding extremely premature birth remains challenging for parents and care providers alike. Recently, concerns have been raised regarding wide practice variation, selection bias, and the limitations of outcomes data in this population. The purpose of this review is to summarize the recent literature relevant to deliveries at extreme prematurity with a focus on outcomes, approaches, and institutional variation. Recent findings Newer data suggest that evidence-based clinical guidelines and protocols for both pregnant women and infants at extreme prematurity are...
Source: Current Opinion in Pediatrics - Category: Pediatrics Tags: NEONATOLOGY AND PERINATOLOGY: Edited by Thomas A. Hooven and Tara M. Randis Source Type: research
This study analyses the differences in birth outcomes between Roma and non-Roma mothers and investigates the potential causes of such differences. METHODS: We conducted a retrospective cohort study of 1,989 non-Roma and 799 Roma mothers who gave birth in 2014 and 2015 at the Gynaecology and Obstetrics Clinic of Louis Pasteur University Hospital in Košice. Data on mothers and new-born infants have been obtained from the birth book and from the reports on mothers at childbirth. For low birth weight we considered the weight of a new-born weighing less than 2,500 grams and as for premature birth we referred to child...
Source: Central European Journal of Public Health - Category: International Medicine & Public Health Tags: Cent Eur J Public Health Source Type: research
Purpose of review To review the literature of the past 18 months (April 2017 through September, 2018) relating to vitamin D and childhood asthma. Recent findings A combined analysis of two clinical trials of maternal vitamin D supplementation trials showed a significant protective effect of vitamin D supplementation trials in the primary prevention of asthma and recurrent wheeze up to age 3 years. Secondary analyses from these trials have also suggested that initial maternal vitamin D status could affect the response to supplementation during pregnancy, with the biggest protective effect in children born to mothers wi...
Source: Current Opinion in Allergy and Clinical Immunology - Category: Allergy & Immunology Tags: PEDIATRIC ASTHMA AND DEVELOPMENT OF ATOPY: Edited by Leonard B. Bacharier and John Oppenheimer Source Type: research
by Joyce Marinho de Souza, Rog ério Giuffrida, Ana Paula Marques Ramos, Glilciane Morceli, Camila H. Coelho, Marcus Vinícius Pimenta Rodrigues Syphilis is a Sexually Transmitted Infection (IST) with significant importance to public health, due to its impact during pregnancy (Gestational Syphilis—GS); especially because syphilis can affect fetus and neonates’ development (mother-to-child transmission—MTCT of syphilis), by increasing susceptibility to abortion, premature birth, skeletal malformations, meningitis and pneumonia. Measures to control and eliminate MTCT of syphilis have failed on ...
Source: PLoS Neglected Tropical Diseases - Category: Tropical Medicine Authors: Source Type: research
This study sought to gain a better understanding of the relationship between duration of PROM in first pregnancy and term of delivery of the subsequent pregnancy.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Session 05 – Obstetrics: Preterm Source Type: research
Conclusions: Our overview supports the conclusion, which has also been endorsed by the American College of Obstetricians and Gynecologists and the American Psychiatric Association, that administration of ECT during pregnancy is relatively safe. Conclusions about safety, however, will become better established with the availability of more data.
Source: Journal of Psychiatric Practice - Category: Psychiatry Tags: ARTICLES Source Type: research
Abstract It is often pointed out that one cannot be "a little bit pregnant," but pregnancy's borders are no longer so crisp. At Children's Hospital of Philadelphia, scientists have created an artificial womb in which "extremely premature" lambs were nurtured for four weeks, enough to make them ready to meet the world. The goal is to advance this technology until it is available for very premature human infants. At present, we put preemies into neonatal intensive care units, which are extremely stressful for the babies and their families, and the things we do to try to support them often cause s...
Source: The Hastings Center Report - Category: Medical Ethics Authors: Tags: Hastings Cent Rep Source Type: research
ConclusionIn women with symptomatic placenta praevia, there is no significant effect on pregnancy prolongation with the use of tocolysis. Tocolysis has no significant effect on other prenatal, perinatal, neonatal and maternal outcomes among women with symptomatic placenta praevia.Systematic review registrationPROSPEROCRD42018091513
Source: Systematic Reviews - Category: International Medicine & Public Health Source Type: research
Preeclampsia (PE) is characterized by new onset hypertension in association with elevated soluble fms-like tyrosine kinase-1 (sFlt-1) and endothelin-1 (ET-1) levels. We and others have previously demonstrated that infusion of sFlt-1 into pregnant rodents causes hypertension, indicating an important role for sFlt-1 in mediating the pathophysiology of the disease. Currently there is no effective treatment for PE except for delivery of the fetal placental unit, making PE a leading cause for premature births worldwide.
Source: American Journal of Obstetrics and Gynecology - Category: OBGYN Authors: Tags: Poster Session II Source Type: research
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