Tag: Congress

 

ObsEva SA Presented Two Late-Breaking Posters at the ASRM 2020 Virtual Scientific Congress October 17-21

 

Geneva, Switzerland and Boston, MA – October 22, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of two posters at the ASRM 2020 Virtual Scientific Congress and Expo during the first ever Late-Breaking Abstract Poster Session.

Late-breaking poster – P-931: Linzagolix may address the long-term treatment needs of women with uterine fibroids who have contraindications to hormonal add-back therapy: results from two Phase 3 randomized clinical trials

Dr. Linda Bradley, Professor of Ob/Gyn and Reproductive Biology and Vice Chair, Ob/Gyn and Women’s Health Institute, Cleveland Clinic OH, is lead author for a late-breaking poster, which discusses the potential for the low-dose (100 mg) of linzagolix, a once daily oral GnRH antagonist, to fill an unmet need for medical treatment of uterine fibroids in women who cannot or prefer to avoid hormonal add-back therapy (ABT). CDC data suggest that up to 50% of women with uterine fibroids may have a contraindication to ABT. Because linzagolix is the only oral GnRH antagonist being developed with a low-dose, no add-back therapy option, it has the potential to address the unique needs of black women, who are both disproportionately affected with uterine fibroids and are more likely to have contraindications to ABT.

Late-breaking poster – P-930: Efficacy and Safety of Linzagolix for the Treatment of Heavy Menstrual Bleeding Due to Uterine Fibroids:  Results from Two Phase 3 Randomized Clinical Trials

The second late-breaking poster, with lead author Dr. Elizabeth Stewart, Professor of Obstetrics and Gynecology and Chair of the Division of Reproductive Endocrinology, Mayo Clinic MN, presented results from PRIMROSE 1 and PRIMROSE 2, the two positive Phase 3 clinical trials, which support the potential best-in-class efficacy of linzagolix in the treatment of uterine fibroids.

The related abstracts are scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.

About ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer outcomes following in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

About Linzagolix

Yselty® (linzagolix) is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.

Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in

ObsEva SA Presented Nolasiban Poster at the ASRM 2020 Virtual Scientific Congress October 17-21

 

Geneva, Switzerland and Boston, MA – October 20, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of a poster at the ASRM 2020 Virtual Scientific Congress and Expo.

Poster number # P-482: The Effect of the Oral Oxytocin Antagonist, Nolasiban, On Pregnancy Rates in Women Undergoing Embryo Transfer Following IVF

Dr. Georg Griesinger, Professor at Luebeck University, Germany, and chair of the Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, is lead author of a poster presenting results from a meta-analysis of the clinical trials and a mechanism of action study of nolasiban, an oxytocin receptor antagonist being developed for its potential to increase pregnancy rates following in vitro fertilization (IVF). Results support the further evaluation of higher doses and/or alternate regimens of nolasiban. ObsEva is partnering with YuYuan BioScience Technology, a Chinese company, for the development of nolasiban.

The related abstract is scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.

About ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer (ET) outcomes following IVF. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

About Nolasiban

Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist which was licensed from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide, exclusive, commercial rights (ex China).

About Assisted Reproductive Technology

Infertility affects about 10% of reproductive-aged couples, with more than two million assisted reproductive technology (ART) treatments (including IVF and intracytoplasmic sperm injection (ICSI)) performed worldwide each year. In China, more than 950,000 ART cycles (IVF, ICSI, fetal ET) were performed in 2017 (National Health Commission of the PRC, presented at the 23rd International Federation of Fertility Societies conference in Shanghai, 2019).

While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and insufficient blood flow to the uterus, may impair the implantation of the embryo.

About YuYuan Bioscience Technology

YuYuan Bioscience Technology is a leading biopharmaceutical company based in China focused on discovering, developing and commercializing innovative medicines for unmet medical needs in the assisted reproductive area. The company continues to introduce a competitive portfolio of therapeutic programs aimed at helping to bring more solutions to this field. YuYuan Bioscience has a top class leadership team with deep experience at assisted reproductive therapeutics and within

State health officials tell Congress they need $8.4B for COVID-19 vaccination effort

State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they do not currently have enough money to carry out the immense logistical effort. 

The letter to bipartisan congressional leaders came from the Association of State and Territorial Health Officials (ASTHO), a group that represents state public health departments, and the Association of Immunization Managers (AIM), which represents states’ vaccination officials. 

While much attention has been placed on the race to develop a coronavirus vaccine, there is also the daunting challenge of distributing that vaccine and getting shots into the arms of over 300 million people in the United States. 

There are additional logistical challenges given that some of the potential vaccines require storage at extremely cold temperatures, meaning they require special freezers. 

Claire Hannan, AIM’s executive director, warned in a statement that without additional funding, the vaccination effort is “doomed to fail.”

“We want to be absolutely clear – states and local partners cannot conduct an unprecedented and incredibly complex national vaccine distribution program without adequate resources,” she added. 

So far, the Centers for Disease Control and Prevention (CDC) has distributed only $200 million to states for vaccination efforts. 

“This funding is a necessary first step but equals approximately 60 cents per person,” Hannan said. “It is not adequate to vaccinate every American with the expected two dose course at this amount.”

The letter calls for $3 billion for workforce recruitment and training for state and local health departments, $1.2 billion for transportation and storage at the needed cold temperatures, $500 million for outreach efforts to fight vaccine misinformation and $1 billion for creating additional vaccination sites, among other requests.

The CDC itself has also told Congress it urgently needs more funding for the vaccination effort, a figure CDC Director Robert Redfield put at $6 billion last month. “The time is now for us to be able to get those resources out to the state, and we currently don’t have those resources,” Redfield said at a congressional hearing in September.

But there is no clear path for Congress to provide that funding, given that lawmakers have been mired in disagreement for months over the next coronavirus relief package, with President TrumpDonald John TrumpFeds investigating if alleged Hunter Biden emails connected to foreign intelligence operation: report Six takeaways from Trump and Biden’s dueling town halls Biden draws sharp contrast with Trump in low-key town hall MORE, Speaker Nancy PelosiNancy PelosiPelosi: Mnuchin says Trump will lobby McConnell on big COVID-19 deal On The Money: McConnell shoots down .8 trillion coronavirus deal, breaking with Trump | Pelosi cites progress on testing provisions | Jobless claims spike to 898K United CEO: Business demand for air travel won’t return until 2024 MORE (D-Calif.) and Senate Majority Leader Mitch McConnellAddison (Mitch) Mitchell McConnellFeinstein’s hug of Lindsey Graham sparks outrage on the left Overnight Health Care: Georgia gets Trump approval for Medicaid work requirements, partial expansion | McConnell shoots

Head Start never stops working for children and families, and neither should Congress

For 55 years, Head Start has stood by America’s children and families. Created as part of the War on Poverty, locally operated Head Start programs have prepared nearly 40 million children from at-risk backgrounds for success in school and life. Today, an unwavering bipartisan commitment from Congress enables Head Start programs across the nation to serve the educational, socio-emotional, health, and nutrition needs of more than 1 million children in safe, nurturing environments.

Fortunately, while COVID-19 has shut down many valuable forces in American life, it hasn’t stopped Head Start. In the months since the COVID-19 pandemic began spreading in the United States, Head Start staff have been working in overdrive to adapt their teaching strategies, sanitize classrooms, make necessary health-related adjustments to facilities, and provide access to quality online and other remote learning opportunities for children and families from at-risk backgrounds ― all while grappling with rising COVID-19 operational costs.

Head Start families are expressing relief that their programs have remained steadfast in their efforts to keep children healthy and prepare them for success in school and life. One Head Start parent in California shared that her program is “incorporating outdoor activity and keeping children on track. They are educating the children about why they cannot visit family and friends. They are supporting parents in managing working from home and helping our children learn at home. Our Head Start program has gone above and beyond in supporting our children.”

This fall, as more Head Start programs are engaged in reopening their classrooms safely, they are confronting the true cost of operating in the COVID-19 era. From PPE for children and staff to increased hours for janitorial staff to additional mental health services for children coping with this new trauma, Head Start programs are facing a funding shortfall that will soon impact the children and families they are supporting in navigating this crisis.

Since the start of COVID-19, Head Start programs have pivoted in countless innovative ways: conducting online classrooms, donning PPE and making home visits to check on children, erecting elaborate screening barriers and devising creative bus routes, arranging contactless health screenings and food drops — doing everything physically and financially possible to ensure children and families living on the margins aren’t pushed further to the edge. Head Start never stopped working.

That’s why Congress and the administration must not stop, either. They can start by making sure Head Start programs have the critical resources necessary to reopen classrooms safely. Based on extensive surveying of Head Start providers, the National Head Start Association estimates operational costs will increase by up to 20 percent this year as individual programs adapt and respond to the pandemic. That’s why the Head Start community has been advocating to Congress for at least $1.7 billion in emergency funding to keep up with COVID-19-related costs — PPE for teachers, IT upgrades to support virtual learning, facility adaptations, additional staff hours to meet smaller classroom ratios for social distancing, and many other needs.

Lack of emergency

Ferring Pharmaceuticals to Share New Reproductive Medicine Data at ASRM 2020 Scientific Congress & Expo

Ferring Pharmaceuticals (US) today announced that it will present eleven company-sponsored abstracts, including six oral presentations, at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Scientific Congress & Expo taking place October 17-20, 2020.

“We look forward to presenting data at this year’s ASRM congress, where leaders will gather virtually to share meaningful research that advances scientific knowledge in the field of reproductive medicine,” said Gaurang Daftary, M.D., M.B.A, Vice President, Reproductive Medicine and Maternal Health at Ferring Pharmaceuticals. “At Ferring, we are committed to addressing the medical needs of patients through the advancement of science. Our presence at ASRM this year underscores that commitment.”

Ferring’s first oral presentation highlights data from a clinical trial involving infertile women with primary hypothalamic amenorrhea, a rare patient population that is unable to ovulate and achieve pregnancy due to deficiencies in their brain’s production or secretion of a key peptide called Gonadotropin Releasing Hormone (GnRH).

Additionally, the company will present three new sub analyses of data from the recently published MEGASET-HR trial. The first abstract characterizes differences in ovarian response dependent upon the type of gonadotropin used and baseline levels of anti-Müllerian Hormone (AMH), a marker of ovarian reserve. The second presents a possible relationship between serum levels of human chorionic gonadotropin (hCG) at the end of stimulation and live birth. The third abstract from the MEGASET-HR trial describes outcomes from the transfer of fresh or frozen embryos designated as normal based on assessment of the number of chromosomes.

The details of all Ferring abstracts presented at the meeting are as follows:

Oral (O-33):
Title: Pulsatile Gonadotropin Releasing Hormone (GnRH) via Subcutaneous Pump for the Treatment of Primary Amenorrhea Associated with Hypogonadotropic Hypogonadism
Date and Time: Saturday, October 17, 2020; 2:30 PM-2:45 PM

Oral (O-169):
Title: Safety evaluation of a novel progesterone vaginal ring (PVR) in luteal phase support: SARA trial results
Date and Time: Monday, October 19, 2020; 1:50 PM-2:05 PM

Oral (O-223):
Title: Differential Ovarian Response to Gonadotropin Preparations Despite Similar Ovarian Reserve: MENOPUR in GnRH (Gonadotropin Releasing Hormone) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) Trial Analysis
Date and Time: Tuesday, October 20, 2020; 1:50 PM-2:05 PM

Oral (O-224):
Title: Serum gonadotropin association with live birth in high-responders undergoing ovarian stimulation: MENOPUR in Gonadotropin Releasing Hormone (GNRH) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) trial analysis
Date and Time: Tuesday, October 20, 2020; 2:05 PM-2:20 PM

Oral (O-225):
Title: Fresh versus frozen euploid blastocyst transfer outcomes in predicted high-responders: MENOPUR in GNRH (Gonadotropin Releasing Hormone) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) trial analysis
Date and Time: Tuesday, October 20, 2020; 2:20 PM-2:35 PM

Poster (P-443):
Title: Similar ovarian response with individualized follitropin delta dosing regimen in Japanese and non-Japanese IVF/ICSI patients
Date and Time: Monday, October 19, 2020; 4:30 PM-6:00 PM

Poster (P-591):
Title: Atosiban and Barusiban improved impaired endometrial blood flow in pregnant rabbits
Date and Time: Monday, October 19, 2020; 4:30 PM-6:00 PM

Poster (P-458):
Title: Similar dose-response profiles for