This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Neurocrine Biosciences Crenessity (crinecerfont) has been given the green light by the US Food and Drug Administration (FDA) as a new treatment for congenital adrenal hyperplasia (CAH). CAH is a group of rare genetic disorders affecting the adrenal glands, which produce essential hormones like cortisol, aldosterone and androgens.
However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow. This was not always the case. “Up
Unlike drugs that alter metabolism or appetite by interacting with hormones, the pill functions entirely mechanically. This approach aims to help users control portions and calorie consumption without the need for surgery, such as gastric banding or bypass, or the side effects commonly associated with appetite-suppressing drugs.
Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.
This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause.
Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. Without proper PTH function, patients may face kidney and bone complications.
The study will assess the drugs effects on body weight, safety and tolerability over a 42-week period. Petrelintide, administered once a week under the skin, targets obesity through its action as an amylin analog, a hormone co-secreted with insulin from the pancreas.
a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 Despite this, the drug remains under watch for further development.
This capital will accelerate the companys clinical programs and support its pipeline of investigational drugs aimed at treatments for metabolic diseases like Prader-Willi syndrome (PWS). In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety.
This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
Eli Lilly launched a 75-second TV commercial called Change in November 2024 to promote the companys GLP-1 obesity drug Zepbound (tirzepatide). This month, Zepbound won FDA approval for obstructive sleep apnea (OSA) , making it the first approved drug for the condition.
Astellas Pharma recently announced the US Food and Drug Administration (FDA) approval of their new medication, Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. Hormone replacement therapy is thought to be one of the most effective treatments for vasomotor symptoms.
The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.
Hidradenitis suppurativa affecting roughly 1% of the population is a chronic skin condition marked by painful boils and abscesses that can significantly disrupt daily life. As reported by Investors.com , RBC Capital Markets analyst Brian Abrahams stated, The drug did hit on statistical significance and could be a viable entrant.
Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development.
Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, 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. percent and 22.5
The latest phase of Oprah’s weight loss journey brought her to GLP-1 receptor agonist drugs, which have taken Hollywood and social media by storm. GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes, have been found to have significant effects on weight loss.
Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. on Tuesday morning, the companys steepest fall in 23 years, according to Bloomberg.
Insulin, a hormone produced by the pancreas, allows glucose to enter cells for energy. NovoLog and Novo Nordisks other rapid-acting insulin, Fiasp, is among some of the drugs up for price negotiations under the Inflation Reduction Act , with new pricing set to take effect at the beginning of next year.
The US Food and Drug Administration (FDA) has issued warnings about the risk of abuse of amphetamine stimulants like Adderall, stating that use for “prolonged periods of time may lead to drug dependence and must be avoided.” The first generic versions of Strattera were approved in 2017 when the drug went off patent.
Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. on Tuesday morning, the company’s steepest fall in 23 years, according to Bloomberg.
Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.
It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone. Thyroid eye disease affects an estimated 200,000 individuals in the US every year.
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. Octreotide is a synthetic analog of somatostatin, a hormone in the body that inhibits the release of several other hormones, including growth hormone (GH), glucagon and insulin.
Known for its innovative approach to GPCR drug discovery, Septerna leveraged its proprietary Native Complex Platform to establish a robust pipeline targeting endocrinology, immunology, inflammation and metabolic diseases. SEP-786, an oral parathyroid hormone 1 receptor (PTH1R) agonist, aims to restore essential mineral balance.
Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating.
GlaxoSmithKline (GSK) unveiled positive safety and efficacy data for its oral anemia drug daprodustat from five pivotal trials for the drug last week. The drug was evaluated for the treatment of both dialysis and non-dialysis patients with anemia stemming from chronic kidney disease (CKD). percent for daprodustat and 10.5
Zilebesiran (formerly ALN-AGT) is one of a new breed of gene-silencing drugs that are intended to treat common, chronic diseases with infrequent dosing to boost compliance with treatment. The post MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran appeared first on.
Lutathera is used to treat adults and children aged 12 years and older with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut and hindgut. Nevertheless, Novartis still believes the drug is on track to achieving blockbuster status.
Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.
Related: Transforming Eye Care: Innovating New Glaucoma and Dry Eye Disease Treatments — Featuring Pierre Simon, VP Marketing, Sight Sciences – Xtalks LifeScience Podcast Ep. One example is Glaukos’ iDose TR , an intracameral implant designed to provide continuous drug therapy inside the eye for up to three years.
Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?
The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.
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). Erythropoietin is a hormone that is produced by the kidneys and signals the body to make red blood cells.
Causes and Risk Factors for Endometriosis As the exact cause of endometriosis remains unclear, many potential causes are being proposed, including retrograde menstruation (where menstrual blood flows back into the pelvic cavity instead of leaving the body), immune system disorders and hormonal imbalances.
Some of the higher-value approved products include contraceptives, such as hormonal vaginal rings and birth control pills. Dr. Reddy’s will also gain Mayne’s generic arrhythmia medication amiodarone, one of the most commonly used drugs for this indication.
Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases. The growing popularity of peptide-based drugs can be attributed to its high specificity, minimal drug-drug interactions, affinity, proven pharmacological value and favorable safety profiles.
The US Food and Drug Administration (FDA) has granted approval to two of Sandoz’s biosimilars to Amgen’s blockbuster bone drugs Prolia (denosumab) and Xgeva (denosumab). Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications.
The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE.
Hypoparathyroidism arises when the parathyroid glands fail to produce enough parathyroid hormone (PTH) or when the PTH produced is ineffective. The company plans to introduce the drug in the US by early 2025. As a prodrug of PTH, it’s designed to release PTH continuously over a 24-hour period with a single daily injection.
For example, pediatric growth hormone deficiency (PGHD) affects approximately one in 3,500 to one in 10,000 children. Existing therapeutic options for PGHD consist of injectable formulations of recombinant human growth hormone (rhGH), administered subcutaneously either on a daily or weekly basis.
While the link between GLP-1 inhibitors and gastrointestinal side effects has been known for diabetics taking the drugs, this is the first study that was conducted among non-diabetics taking them for weight loss. Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes.
Recognized with Fast Track designation from the US Food and Drug Administration (FDA), fasedienol could become a much-needed treatment option for the 30 million Americans affected by SAD. If successful, this trial could pave the way for a New Drug Application (NDA) submission.
In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content