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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.
If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the lifesciences. Here is a look at some lifescience trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.
In this episode, Ayesha discussed the FDAapproval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP).
Biosimilars are biological products highly similar to an already FDA-approved reference product, with no clinically meaningful differences in terms of safety, purity and potency. Insulin, a hormone produced by the pancreas, allows glucose to enter cells for energy. Approximately 8.4
This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDAapproval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause.
In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety. This approach aims to combine TAS2R activation with enhanced incretin hormone modulation, potentially offering a more robust treatment for obesity and related conditions.
Amvuttra’s FDAapproval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. TTR is made in the liver and is involved in carrying the thyroid hormone thyroxine (T4) and retinol (vitamin A) to the liver.
The US Food and Drug Administration (FDA) has approved Itovebi (inavolisib) for the treatment of adults with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation.
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.
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.
Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy. The tablet consists of two hormones: norethindrone acetate, a type of progestin, and ethinyl estradiol, a synthetic form of estrogen.
It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone. It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDAapproval in 2020.
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.
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. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.
Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.
Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide.
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.
Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDAapproval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.
Related: GSK’s Dostarlimab Wins FDAApproval for dMMR Endometrial Cancer. Darbepoetin alfa is a synthetic version of the hormone erythropoietin, which is made in the kidneys and stimulates the production of red blood cells (RBC), or erythrocytes. What is Daprodustat?
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.
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. The company is currently constructing a facility in China and is also planning for one in Japan.
Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. Current treatments include hormonal therapies that focus on blocking the function of the estrogen receptor, curbing its production or degrading the receptor itself.
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.
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.
It has been a year dominated by the pandemic and many lifesciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. NT-814 is a non-hormonal drug that works on the neurokinin (NK) 1,3 receptor antagonist, thus treating the vasomotor symptoms associated with the menopause.
Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDAapproval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.
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. This comprehensive action of efruxifermin addresses the multifaceted nature of MASH.
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.
Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDAapproved Zepbound for chronic weight management in adults with obesity.
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.
Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. It occurs when the formation of new bone doesn’t keep up with the loss of old bone. The disease often progresses without symptoms until a fracture happens, typically in the wrist, hip or spine.
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. MASH is known to occur in an estimated three to five percent of adults in the US.
They mimic the action of GLP-1, a hormone that helps regulate blood sugar levels by enhancing insulin secretion. Ozempic and Wegovy continue to be blockbusters for Novo, despite facing competition from Eli Lilly’s dual GLP-1/GIP agonist Mounjaro (tirzepatide), which won FDAapproval in May 2022.
FDA-approved ADHD-specific non-stimulants are a relatively newer class of medication designed to treat ADHD that have much fewer side effects than stimulants. Norepinephrine is a hormone and neurotransmitter that helps in alertness and maintaining control in high-stress situations.
Novartis’ Tafinlar and Mekinist received FDAapproval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. Novartis is also investigating several other medications for tumors and solid tumors, many of which are in Phase III trials.
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 (voclosporin), developed by Aurinia Pharmaceuticals, is a calcineurin inhibitor that was approved by the FDA in 2021 for the treatment of adults with active lupus nephritis (LN).
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.
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.
Pancreatic cancer occurs when cells in the pancreas, a vital organ responsible for producing enzymes and hormones, begin to grow uncontrollably. This approval allows Onivyde to be used earlier in the treatment process, offering new options for patients with advanced disease.
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.
Evofem Biosciences announced the launch of their new national campaign called, “Get Phexxi,” designed to raise awareness about the company’s non-hormonal birth control method. In May 2020, the US Food and Drug Administration (FDA) approved Phexxi , a non-hormonal contraceptive for women.
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.
AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. billion to $1.28
This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. Fasenra is also looking to get FDAapproval for chronic rhinosinusitis with nasal polyps, as is GlaxoSmithKline’s Nucala.
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