XTalks

JUNE 29, 2023

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.

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Life Science Hormones FDA Approval Development 52

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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Hormones FDA Approval Containment Medicine 52

XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.

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pharmaphorum

DECEMBER 1, 2021

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

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Vaccination Vaccine Development Hormones 102

XTalks

AUGUST 10, 2022

The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo. This is the first approved therapy for patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

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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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Hormones FDA Approval Drugs Clinical Trials 95

XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.

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FDA Approval Drugs Sales Development 52

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

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Hormones Drugs FDA Approval Sales 95

Pharmaceutical Technology

MARCH 7, 2023

Medical interventions typically recommended during this stage include drugs to treat depression and hormone replacement therapies (HRT). Science drives new developments in medications Specific drug-based treatments for symptoms of anxiety and depression during perimenopause are largely unexamined.

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The Pharma Data

NOVEMBER 21, 2021

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. 3] Achondroplasia is caused by mutations in the FGFR3 gene. Inheritance is autosomal dominant.[1][2]

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FDA Approval Drugs Regulation Genetics 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. Partnering with EraCal builds upon the success of Novo Nordisk’s Wegovy (semaglutide) chronic weight management drug, which was approved by the FDA in June 2021.

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FDA Approval In-Vitro Regulation Hormones 118

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.

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Drug Discovery World

DECEMBER 22, 2022

A new drug based on the active ingredient Lutetium-177 PSMA-617 has been approved by the European Commission for the treatment of metastatic prostate cancer carrying the surface molecule PSMA (prostate specific membrane antigen). . It had already received FDA approval for the United States in March of this year.

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Drugs Clinical Trials Clinical Trials Hormones 52

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. GLP-1 agonists were first developed as diabetes treatments.

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pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

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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 58

XTalks

AUGUST 15, 2023

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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FDA Approval Gene Hormones Licensing 52

Pharmaceutical Technology

OCTOBER 13, 2022

The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women. In August this year, it gained a second FDA endorsement to treat moderate to severe endometriosis.

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Hormones FDA Approval Drugs Marketing 130

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval 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. Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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FDA Approval In-Vivo Gene Editing Drugs 52

XTalks

FEBRUARY 7, 2023

The FDA approval 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.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

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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. The doublet is working together on developing SCONE , a small capacity, disposable device.

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Hormones FDA Approval Trials Drugs 52

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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XTalks

NOVEMBER 20, 2023

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

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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. There are on-going studies to develop formulations with extended duration of action.

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Clinical Trials Clinical Trials Trials Insulin 59

pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster. Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects.

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The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

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Drug Discovery World

NOVEMBER 16, 2022

Secreted proteins are a proven class of biologics with largely underutilised therapeutic potential, despite the impact of FDA-approved biologics based on secreted proteins such as insulin, human growth hormone, and erythropoietin.

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Protein Engineer Immune Response Insulin 52

XTalks

NOVEMBER 26, 2020

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. Lerner researchers developed a novel artificial intelligence platform to identify potential drugs for COVID-19, finding melatonin to be a promising candidate.

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Delveinsight

AUGUST 31, 2021

FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency. Growth Hormone Deficiency , commonly known as dwarfism, can constitute short stature and complications with metabolism, which arise due to inadequate production of growth hormones by the pituitary gland inside the body.

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XTalks

MARCH 8, 2024

Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. According to the FDA, Jubbonti is approved for the same indications as Prolia, which include individuals at high risk for fracture including postmenopausal women with osteoporosis and men with osteoporosis.

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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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XTalks

NOVEMBER 9, 2023

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 FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

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The Pharma Data

SEPTEMBER 10, 2021

Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

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Hormones FDA Approval Drugs Development 52

Drug Discovery World

APRIL 23, 2024

Although not a test to diagnose concussion, a biomarker test developed by Abbott Laboratories helps to determine whether a patient should receive a CT scan to rule out haemorrhage. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI.

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The Pharma Data

APRIL 4, 2023

Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Initiate hormone replacement as indicated. Withhold KEYTRUDA depending on severity.

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FDA Approval Containment Hormones Dermatology 40