XTalks

FEBRUARY 18, 2025

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

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Insulin FDA Approval Production Hormones 59

XTalks

JANUARY 30, 2025

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 FDA approved Kisqali (ribociclib) to reduce the risk of recurrence in HR+/HER2- early breast cancer.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. 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. T3 is a major hormone in the blood that regulates thyroid levels.

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Drugs Gene Hormones Clinical Trials 317

XTalks

JULY 26, 2024

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.

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FDA Approval Hormones Containment Drugs 52

pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes.

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The Pharma Data

APRIL 28, 2023

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya ® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5

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XTalks

MARCH 18, 2025

Standard treatment strategies include combinations of antibiotics, hormonal therapies and biologic agents most notably adalimumab (Humira), the only FDA-approved biologic for moderate to severe cases while surgery remains an option for advanced disease.

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Pharmaceutical Technology

MARCH 7, 2023

Due to a growing body of research, the connection between mental health and perimenopause is becoming clearer, namely its impact on mood and the onset of depression and anxiety. However, despite focused efforts in scientific research, this connection is still largely unexplored in the pharmaceutical space.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

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XTalks

MAY 17, 2023

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.

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XTalks

JULY 17, 2024

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.

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Trials Hormones Clinical Trials Clinical Trials 59

XTalks

APRIL 29, 2022

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.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.

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XTalks

NOVEMBER 10, 2021

Related: GSK’s Dostarlimab Wins FDA Approval 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? Market Size and Regulatory Pathway.

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Trials Hormones Drugs FDA Approval 97

pharmaphorum

JANUARY 26, 2023

Merck has said it will abandon the KEYNOTE-991 study of PD-1 inhibitor Keytruda (pembrolizumab) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after it showed no benefit on either overall survival (OS) or radiographic progression-free survival (rPFS) when the data was analysed midway though.

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Hormones Trials FDA Approval Clinical Development 59

Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device.

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XTalks

SEPTEMBER 6, 2024

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.

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XTalks

AUGUST 22, 2024

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.

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Hormones FDA Approval Trials Clinical Trials 52

pharmaphorum

OCTOBER 11, 2020

When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.

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pharmaphorum

APRIL 1, 2022

And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? In September of 2021, the FDA approved Byooviz , which references Roche and Novartis’ blockbuster eye drug Lucentis.

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XTalks

SEPTEMBER 17, 2020

While clinical researchers occasionally need to identify and validate a new surrogate endpoint for a given trial, choosing endpoints that have been previously used as the basis of NDAs and BLAs can clear the path to eventual approval. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

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XTalks

FEBRUARY 21, 2024

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. Tirzepatide’s efficacy in MASH treatment is just one facet of ongoing research into its broader therapeutic potential.

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Clinical Trials Clinical Trials Trials Insulin 59

XTalks

OCTOBER 11, 2023

They mimic the action of GLP-1, a hormone that helps regulate blood sugar levels by enhancing insulin secretion. There was also a high rate of biliary disease in patients taking either liraglutide or semaglutide, but the researchers said the difference was “not found to be statistically significant.” Patients on Contrave had a 0.4

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Drugs Insulin Hormones FDA Approval 59

XTalks

NOVEMBER 12, 2024

November is Pancreatic Cancer Awareness Month , a time dedicated to increasing public understanding of this challenging disease, supporting patients and their families and advancing research for better treatment options. For this reason, researchers are working hard to find new methods to identify pancreatic cancer sooner.

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Delveinsight

DECEMBER 7, 2020

In April 2018, the FDA approved IDx ‘s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a disorder that can lead to blindness. The device can be configured to inject a specific dose of the hormones into the patient.

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Protein Insulin Development Hormones 56

XTalks

JUNE 27, 2022

Novartis’ Tafinlar and Mekinist received FDA approval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. Tafinlar and Mekinist Combination Clinical Trial Results. The safety and efficacy of the Tafinlar and Mekinist combination therapy was evaluated in three clinical trials.

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Clinical Trials Clinical Trials Trials Gene 52

Find Me Cure

OCTOBER 13, 2019

This Breast Cancer Awareness Month we’d like to talk about emerging areas in metastatic breast cancer treatment since clinical research has come so far in recent years. CDK4/6 inhibitors are used alongside hormone therapy. All of these drugs and therapies are the result of continuous clinical research on breast cancer.

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The Pharma Data

JUNE 28, 2021

Medical Director, National Research Institute and Principal Investigator of SURPASS-2. Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. GIP is a hormone that may complement the effects of GLP-1.

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Clinical Trials Clinical Trials Insulin Hormones 52

XTalks

MAY 10, 2023

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).

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Drugs Clinical Trials Clinical Trials Antibody 52

XTalks

JULY 6, 2023

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

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XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors.

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XTalks

FEBRUARY 19, 2021

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.

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Hormones Production FDA Approval Marketing 88

The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec. Indication.

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XTalks

OCTOBER 18, 2024

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. Why Target PIK3CA Mutations?

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XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors.

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FDA Approval Drugs Sales Development 52

The Pharma Data

MAY 13, 2021

But I’ve been a long time researcher passionate to help people all over the world on how to live better lives and spread awareness on how anyone can help support a healthy weight loss. Well, sleep keeps the “hunger hormones” (ghrelin and leptin) in check. Well, sleep keeps the “hunger hormones” (ghrelin and leptin) in check.

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XTalks

SEPTEMBER 12, 2024

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. Participate in Events: Many cities host charity events during September.

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