Polycystic Ovary Syndrome

NEWNAN, Ga., Oct. 3, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Sabrina Rene, MD, FACE is acknowledged as a Pinnacle Professional Member for her contributions in Endocrinology. Continue Reading Sabrina Rene Dr. Sabrina Rene is a trailblazer in the field of endocrinology, dedicated to providing top-notch care to her local community. With a wealth of expertise in endocrine disorders and diabetes management, Dr. Rene has established herself as a trusted medical practitioner. She is a specialist in endocrinology, diabetes, PCOS, thyroid cancer, endocrine disrupting chemicals, thyroid ultrasound interpretations, and performing fine needle aspiration and biopsies of thyroid nodules. Armed with a Bachelor of Arts from New York University and a Doctor of Medicine from Howard University, Dr. Rene embarked on a journey of medical excellence. She further honed her skills through a rigorous residency at the prestigious Mayo Clinic, followed by a fellowship at Emory University, where she specialized in endocrinology. As a Fellow of the American College of Endocrinology (FACE) and a member of esteemed organizations such as the Endocrine Society; the National Medical Association (NMA); and the American Association of Clinical Endocrinologists, Dr. Rene remains at the forefront of advancements in her field. Board-certified in Endocrinology, diabetes, metabolism, and a certified expert in endocrine-disrupting chemicals, her dedication to continuing education ensures that she stays abreast of the latest developments and technologies in endocrinology. Touting more than 24 years of experience, Dr. Rene has been in private practice for five years, is co-owner of a group private practice for the last 10 years, and has been working in healthcare since 2018. Her extraordinary achievements have been punctuated with numerous awards and accolades including Top Doctors of America since 2018 and Best in Georgia magazine for endocrinology in April 2024. Beyond her professional commitments, Dr. Rene finds joy in traveling, especially to St. Lucia, and exploring new cultures, art, and music. She was also a member of the church choir. Her passion for holistic healthcare is reflected in her approach to patient care, where she considers not just the physical symptoms but also the overall well-being of her patients. The doctor said that her faith in God helps her to see the humanity and dignitiy in every patient. "This enables me to show compassion and empathy during difficult health crisis. I strive towards a thorough analysis of the endocrine condition coupled with education of the patient to understand their diagnosis," she explained. Dr. Rene's vision for the future includes conducting clinical research with a focus on endocrine-disrupting chemicals, aiming to shed light on their impact on human health. With a philosophy rooted in a holistic approach to medicine, she remains committed to providing comprehensive care to her patients, addressing both their medical needs and overall wellness. To her dear husband Andre, her parents, and brother, Dr. Rene expresses heartfelt gratitude for their unwavering love and support. She also thanks her many professional coaches, including Dr. Catherine Woodhouse, friends, and family for their encouragement throughout her journey which she notes has been instrumental in her pathway to success, and she looks forward to continuing to make a difference in the lives of her patients and community. Dr. Sabrina Rene's dedication to excellence and holistic healthcare sets her apart as a leader in the field of endocrinology, ensuring that her patients receive the highest quality of care and support. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Neurocrine Biosciences has announced that the US Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) for crinecerfont, granting them Priority Review designations. The applications cover the treatment of children, adolescents, and adults with classic congenital adrenal hyperplasia (CAH). If approved, crinecerfont would represent the first new treatment for CAH in 70 years and the first-in-class therapy offering a novel mechanism of action to address this rare and serious endocrine disorder. LAS VEGAS, Sept. 30, 2024 /PRNewswire/ -- CAH refers to a rare set of inherited autosomal recessive disorders that impair hormone production in the adrenal glands, which sit on top of the kidneys. Normally, these glands produce three types of hormones: corticosteroids, mineralocorticoids, and androgens. CAH is mostly caused by mutations in the 21-hydroxylase gene, which accounts for more than 90% of cases. In rare instances, mutations in the 11-hydroxylase gene can also lead to CAH. In the 7MM, the US accounted for the highest prevalent cases of congenital adrenal hyperplasia in 2023, with around 50% of the total prevalent cases across the 7MM; these numbers are expected to increase during the forecast period (2024–2034). DelveInsight's analysis reveals that a higher prevalence of diagnosed congenital adrenal hyperplasia is observed in the 18-year-old and above age group across the 7MM. Among mutation-based congenital adrenal hyperplasia cases, 21 OHD (CYP21A2 gene mutation) represents a higher prevalence compared to 11-Beta hydroxylase (CYP11B1 gene mutation), and others. The approach to managing CAH differs significantly based on its type and severity. While CAH cannot be completely cured, it can be managed effectively. For classical CAH, treatment begins shortly after birth and continues throughout the individual's life. Those with classical CAH should work with a team of healthcare professionals, including experts in pediatric endocrinology, uro-gynecologic surgery, psychology, and genetics. With appropriate care, individuals with classical CAH can lead normal and satisfying lives. In contrast, treatment for non-classical CAH may not be necessary, depending on the severity of symptoms. The management of classic CAH focuses on three main objectives: correcting adrenal insufficiency, lowering adrenal androgens to appropriate levels, and preventing iatrogenic hypercortisolism. Hydrocortisone is the primary glucocorticoid used, administered two to three times daily with higher doses in the morning and lower doses in the evening to align with the body's natural circadian rhythm. For NC-CAH, cortisol replacement is generally unnecessary, except in specific situations such as adult women with hyperandrogenism and fertility problems, or pediatric patients experiencing rapidly advancing precocious puberty. Currently, the only medication approved in Europe for CAH treatment is EFMODY (Hydrocortisone Modified-release Hard Capsules) by Neurocrine Biosciences. Learn more about the FDA-approved congenital adrenal hyperplasia drugs @ Drugs for Congenital Adrenal Hyperplasia Treatment EFMODY replicates the natural circadian rhythm of cortisol secretion. It compensates for low cortisol levels in patients with congenital adrenal hyperplasia, aiding in the management of the condition's symptoms. Approved for use in adolescents aged 12 and older, as well as adults, EFMODY uses hydrocortisone—a glucocorticoid that affects various tissues through intracellular steroid receptors. Containing synthetic cortisol, EFMODY gradually releases it in the intestines to mimic the body's natural cortisol release, helping to restore hormone balance and alleviate condition-related issues. In May 2021, the EMA approved EFMODY for treating congenital adrenal hyperplasia in patients aged 12 and above. Diurnal launched the drug in Germany and Austria in September 2021, and later in the United Kingdom. In November 2022, Neurocrine Biosciences acquired Diurnal for approximately USD 55 million. To know more about congenital adrenal hyperplasia treatment options, visit @ New Treatment for Congenital Adrenal Hyperplasia The congenital adrenal hyperplasia pipeline is strong with many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Neurocrine Biosciences' Crinecerfont, Spruce Biosciences' Tildacerfont (SPR001), Crinetics Pharmaceuticals' Atumelnant (CRN04894), BridgeBio's BBP-631, Lundbeck's Lu AG13909, and others. Discover which therapies are expected to grab major congenital adrenal hyperplasia market share @ Congenital Adrenal Hyperplasia Market Report Crinecerfont is an investigational oral medication that acts as a selective antagonist for the corticotropin-releasing factor Type 1 receptor (CRF1). It's being developed to manage and regulate high levels of Adrenocorticotropic Hormone (ACTH) and adrenal androgens without relying on glucocorticoids, specifically for treating congenital adrenal hyperplasia caused by 21-hydroxylase deficiency. By blocking the CRF1 receptor, Crinecerfont reduces the overproduction of ACTH, which in turn decreases the excess production of androgens seen in CAH patients. This mechanism aims to normalize hormone levels and address the root cause of the condition. In July 2024, Neurocrine Biosciences announced that the FDA has accepted its two New Drug Applications (NDAs) for crinecerfont, both with Priority Review designations. These applications are for treating classic congenital adrenal hyperplasia in children, adolescents, and adults. If approved, crinecerfont would become the first new treatment for CAH in 70 years and a pioneering therapy with a novel approach for this rare endocrine disorder. The NDAs for crinecerfont include (1) a capsule formulation (NDA# 218808) and (2) an oral solution formulation (NDA# 218820), both addressing the efficacy and safety of crinecerfont for classic CAH. The FDA has set Prescription Drug User Fee Act (PDUFA) target action dates for these applications as December 29 and December 30, 2024, respectively. The FDA has indicated it does not plan to hold an advisory committee meeting regarding these NDAs. Crinecerfont received an Orphan Drug designation (ODD) in March 2019 and a Breakthrough Therapy designation (BTD) in December 2023. The results from the CAHtalyst Phase III trial, involving both pediatric and adult patients with CAH caused by 21-OHD, were published online in The New England Journal of Medicine on June 2 and June 1, respectively, and were also presented at ENDO 2024. BBP-631 is a gene therapy in development using adeno-associated virus (AAV) to target the root cause of congenital adrenal hyperplasia due to 21-hydroxylase deficiency. This therapy aims to deliver a functional copy of the 21-hydroxylase gene directly to the adrenal glands, where hormones are produced. Animal studies have demonstrated its effectiveness in providing consistent and long-term delivery to the adrenal glands. If successful, BBP-631 could help restore natural hormone and steroid levels in people with CAH, allowing them to produce cortisol and aldosterone—something no current treatments or clinical trials can achieve. BridgeBio envisions this gene therapy as a potential solution to correct the hormonal imbalance caused by CAH. Tildacerfont is a new-generation antagonist targeting the Corticotropin-releasing factor (CRF1) receptor. It aims to significantly enhance disease management and decrease reliance on steroids for patients with classic congenital adrenal hyperplasia and other conditions associated with high ACTH levels. By binding to CRF1 receptors, tildacerfont reduces the overproduction of ACTH and, consequently, lowers the production of adrenal androgens like androstenedione in patients with CAH and Polycystic Ovary Syndrome (PCOS). In August 2024, Spruce Biosciences announced that the top-line results from the CAHmelia-204 study, which evaluates tildacerfont in adult CAH patients, and the CAHptain-205 study, which assesses the drug in both adult and pediatric CAH patients, are expected to be released in the fourth quarter of 2024. Discover more about drugs for congenital adrenal hyperplasia in development @ Congenital Adrenal Hyperplasia Clinical Trials The anticipated launch of these emerging therapies for congenital adrenal hyperplasia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the congenital adrenal hyperplasia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for congenital adrenal hyperplasia is expected to grow from USD 20 billion in 2023 with a tremendous CAGR of ~40% by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. DelveInsight's latest published market report titled as Congenital Adrenal Hyperplasia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the congenital adrenal hyperplasia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The congenital adrenal hyperplasia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Congenital Adrenal Hyperplasia Gender-specific Cases of Congenital Adrenal Hyperplasia Age-specific Cases of Congenital Adrenal Hyperplasia Mutation-based Cases of Congenital Adrenal Hyperplasia Type-specific Cases of Congenital Adrenal Hyperplasia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM congenital adrenal hyperplasia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this congenital adrenal hyperplasia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the congenital adrenal hyperplasia market. Also, stay abreast of the mitigating factors to improve your market position in the congenital adrenal hyperplasia therapeutic space. Related Reports Congenital Adrenal Hyperplasia Pipeline Congenital Adrenal Hyperplasia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAH companies, including Spruce Biosciences, Lundbeck, among others. Congenital Adrenal Hyperplasia Epidemiology Forecast Congenital Adrenal Hyperplasia Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and CAH epidemiology trends. Adrenal Crisis Market Adrenal Crisis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key adrenal crisis companies including Eton Pharmaceuticals, Antares Pharma , among others. Adrenal Crisis Pipeline Adrenal Crisis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key adrenal crisis companies, including Eton Pharmaceuticals, Antares Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iStock/melitas Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse. Since the U.S. Supreme Court overturned the landmark Roe v. Wade ruling in 2022, taking away abortion as a constitutional right, 14 states have banned abortion . Then, in February, the Alabama Supreme Court ruled that frozen embryos are considered “children” and that a person could be held liable for destroying them. Following the judicial order, some healthcare providers in the state suspended in vitro fertilization (IVF) services. Experts warn that these changes in laws relating to abortion and IVF could create mistrust and instill a fear of sharing medical records among women, creating ripple effects in clinical research into female reproductive health. Christopher Hart, a partner at the law firm Foley Hoag, noted that reproductive rights are currently fragmented across the U.S. While some states have voted to protect women’s rights to abortion, others have opted to ban them. These restrictive laws have created a hostile environment, he added. Massachusetts was among the first states to pass a shield law “to, as much as possible, protect reproductive health data from falling into the hands of hostile prosecutors in other states or hostile private parties seeking such information,” Hart said on BioSpace ’s Denatured podcast . This is as opposed to “hostile states” like Tennessee, “where the opposite is happening,” with attempts to support criminal prosecutions, he said. “There is just so much uncertainty about how protected such information will ultimately be over the long run,” Hart told BioSpace . “I can imagine it will make some women think twice before sharing the data for clinical trial research.” Gaurav Josan, senior vice president of research and development at Clario, a clinical trial data management company, echoed this sentiment. “[Women] might want to hold back some information which they feel can be used against them.” Derailing Progress Women have historically been underrepresented in clinical trials. In 1977, an FDA policy recommended excluding women of childbearing age from Phase I and early Phase II drug trials after the use of a sedative called thalidomide by pregnant women led to the birth of babies with severe deformities. “If a woman were to become pregnant during a clinical trial, we don’t know the risk to the fetus, and companies feel it’s riskier to include them,” said Kathryn Schubert, CEO of the Society for Women’s Health Research. “We saw this in the 1960s with the thalidomide trials, and I think that still, to this day, is top of mind for researchers and industry.” However, noting the consistent lack of data on women in clinical trials, the National Institutes of Health instituted the Revitalization Act in 1993, requiring all NIH-funded research to incorporate minorities and women, including those of childbearing age. Some studies suggest that women’s participation in clinical trials has improved over the last decade; however, it is still nowhere near equal to that of men. Josan said the new laws could mar the effort to increase representation of women in clinical trials. “We were moving the needle in the right direction, and now there is this hesitance among women to share their medical background due to privacy concerns,” she told BioSpace . But Karen Correa, former vice president and head of global clinical operations at Takeda Pharmaceuticals, pointed out that clinical trials usually do not require details about women’s abortion history. “Most clinical trials would ask female participants if they can have children and what mode of contraception they use. I have rarely seen abortion history as an inclusion or exclusion criterion,” Correa told BioSpace . She added, however, that abortion history may be a part of the inclusion criteria for trials related to female reproductive health conditions such as polycystic ovarian syndrome. “In such cases, I can see why women may choose to hide the data due to fear of prosecution,” Correa said. As for IVF, Elisa Cascade, chief product officer at the clinical research services firm Advarra, said it is unclear how the restrictions may impact clinical trial enrollment. In many cases, it may make women wary of sharing their IVF history. “Depending on the scope of the data and the trial, some women may choose not to participate at all.” Cascade also pointed out another possibility, however: the restrictions could also spark an interest in trials related to non-IVF-assisted reproductive technologies. “Being denied IVF due to state restrictions could generate interest in participating in studies for a new drug being tested for infertility.” Broader Impacts According to Schubert, the new abortion laws could slow down research on women’s health in general. If women hold back information, she said, “this could result in an unintended consequence of lack of inclusion and representation, lack of desire to participate in these trials and broader research, and a wider gender health gap.” Some expressed concern that if women’s participation in clinical trials drops, it may accentuate the gender gap in the data used to train AI models for clinical trials. According to Rohit Nambisan, CEO of Lokavant, which provides AI-driven data insights to clinical researchers, clinical trials have historically enrolled around 80% white participants, with a majority of that indexing toward males vs. females. The new laws may perpetuate this, he said. “The changes in the legal landscape for reproductive rights can substantively impact the availability of women’s health data. If women are less able to access certain health services due to legal restrictions, data collected will not well represent the spectrum of women’s health needs and outcomes.” Cascade said there is a dire need to make women feel included in clinical trials and ensure equitable representation from different ethnic groups so that new medicines in the market are safe and effective for everyone. “But the new laws could make women feel disenfranchised by the medical system and less willing to participate in clinical trials and contribute medical information. I don’t think anyone has thought through the long-term implications of this.”