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The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinicaltrial. Furthermore, Enhertu’s safety profile was in line with prior clinicaltrials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm.
The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinicaltrial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%
A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary. According to figures from GlobalData’s clinicaltrials database, research into mCRPC treatments has been on the rise over the past 10 years. Trials peaked at 115 in 2018 before declining to 91 last year.
The therapy is approved to be used in combination with glucocorticoid replacement therapies (steroids) to control androgen levels in adults and pediatric patients four years of age and older with classic CAH. Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels.
The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. Last week, the company and Confo Therapeutics signed a global licence deal for CFTX-1554, the latter’s clinical-stage peripheral pain candidate.
GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.
Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinicaltrial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone.
In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety. In a Phase II trial involving patients with hyperphagia, ARD-101 was well tolerated and achieved an approximate eight-point reduction in hunger scores. The competitive landscape is equally dynamic.
Related: Eli Lillys Zepbound Approved as First Treatment for Obstructive Sleep Apnea The commercial describes Zepbounds mechanism of action as a dual receptor against that works by activating two naturally occurring hormone receptors in [the] body [GLP-1 and GIP-1]. Its changing how much weight I lose, up to 48 lbs, he says.
Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinicaltrials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.
Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly. Due to its ability to mimic somatostatin, octreotide is used to treat various conditions associated with excessive hormone production.
Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinicaltrial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.
Additionally, panellists expressed doubts regarding Intercept’s use of a surrogate endpoint in its clinicaltrial. Specifically, the FDA questioned “how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes”.
In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. The results still require further validation, including experimental and clinical evaluation. The list also included melatonin.
Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDAapproved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.
Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. This approval follows the promising results of the Phase III EMERALD global clinicaltrial published in the Journal of Clinical Oncology.
The FDAapproval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinicaltrial investigator.
Related: GSK’s Dostarlimab Wins FDAApproval for dMMR Endometrial Cancer. In the ASCEND trials, Daprodustat was comparable to Amgen’s Aranesp (darbepoetin alfa), an erythropoiesis-stimulating agent (ESA), with respect to heart safety. What is Daprodustat?
The FDAapproval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.
Yorvipath, developed using Ascendis Pharma’s TransCon technology, is the first and only approved treatment for hypoparathyroidism, marking this approval as a major milestone. Hypoparathyroidism arises when the parathyroid glands fail to produce enough parathyroid hormone (PTH) or when the PTH produced is ineffective.
Xtandi for Non-Metastatic Prostate Cancer In late 2023, Pfizer and Astellas’ Xtandi (enzalutamide) received the US Food and Drug Administration (FDA) approval for use in non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. Prostate Cancer Awareness Month is a time to act.
There are currently no FDA-approved drug therapies for MASH, and the disease is characterized by excess fat accumulation and inflammation in the liver, which leads to liver scarring or fibrosis. ClinicalTrials for MASH Treatment The tirzepatide trial involved approximately 190 adults with MASH at different stages.
WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDAapproval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.
Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDAapproval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.
Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. The company is currently preparing for further clinicaltrials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).
Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed.
In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1 There was some steady progress in neurology – in February FDAapproved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. months, compared with 6.7 Neurology on the march.
Novartis’ Tafinlar and Mekinist received FDAapproval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. Tafinlar and Mekinist Combination ClinicalTrial Results. The safety and efficacy of the Tafinlar and Mekinist combination therapy was evaluated in three clinicaltrials.
There currently are drugs that do just that but now they’re in clinicaltrials for metastatic breast cancer as well. CDK4/6 inhibitors are used alongside hormone therapy. There are antibody drugs targetting those cells that are already FDAapproved and there are antibody drugs still in trials.
today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinicaltrial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinicaltrial sites in 28 countries. About TALAPRO-3 Trial.
We talked about the emergence of dozens of CRISPR biotechs last year and the growing number of CRISPR-based therapies in clinicaltrials for conditions ranging from Duchenne muscular dystrophy (DMD) and sickle cell disease (SCD). Patients can also communicate with their providers more often from the comfort of their own home.
The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. Lupkynis was the first FDA-approved oral medication specifically indicated for the treatment of LN. What Is the Theme of World Lupus Day 2023?
Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. MASH is intricately linked to cardiovascular, kidney and metabolic disorders.
Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. 6] ERLEADA ® is being studied in five Phase 3 registrational clinicaltrials.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinicaltrials. The safety profile was consistent with prior studies of ERLEADA ® , with no new safety signals observed.
Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinicaltrials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
FDAapproval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. 2] ERLEADA ® received U.S. For more information, visit www.ERLEADA.com. Adverse Reactions — The most common adverse reactions (?10%)
” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDAapproval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.
Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDAapproval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDAapproval.
Novartis has spent three decades advancing breast cancer treatments, focusing on hormone receptor-positive (HR+), HER2-negative breast cancer, the most common subtype. Last year, the FDAapproved Kisqali (ribociclib) to reduce the risk of recurrence in HR+/HER2- early breast cancer. Novartis dedicated approximately $0.47
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