Antibody, FDA Approval, Hormones and Life Science

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

XTalks

AUGUST 15, 2023

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 FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval

FDA Approval Gene Hormones Licensing

COVID-19 and Melatonin: Researchers Use AI To Study New Treatment Option

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. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

Research

Research Hormones Protein Regulation

Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

XTalks

FEBRUARY 5, 2024

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. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval

FDA Approval Drugs Sales Development

Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

XTalks

MARCH 8, 2024

Denosumab is a RANKL (receptor activator of nuclear factor kappa beta ligand) monoclonal antibody that blocks the ability of RANKL to bind to its receptor RANK. Jubbonti is the first interchangeable biosimilar approved to treat osteoporosis and increase bone mass.

Drugs

Drugs FDA Approval Production Immune Response

Top 40 Best-Selling Cancer Drugs in 2023 by 2022 Data

XTalks

FEBRUARY 5, 2024

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. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval

FDA Approval Drugs Sales Development

World Lupus Day 2023 and Novel Investigational Drugs for Lupus

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. 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.

Drugs

Drugs Clinical Trials Clinical Trials Antibody

2020 review – Pharma’s progress outside of COVID-19

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences 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.

Marketing

Marketing Gene Silencing Gene Drugs

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

SEPTEMBER 17, 2020

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.

Trials

Trials Gene Hormones Clinical Trials

AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

FDA Approval

FDA Approval HR Hormones Antibody

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

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.

HR

HR Hormones FDA Approval Antibody

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval 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 FDA approval.

Sales

Sales Manufacturing FDA Approval Life Science

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

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. It was also given FDA priority review. billion to $1.28

HR

HR FDA Approval Gene Trials

AstraZeneca’s Fasenra Shown to Eliminate Steroid Use in Asthma Patients

XTalks

NOVEMBER 2, 2020

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 FDA approval for chronic rhinosinusitis with nasal polyps, as is GlaxoSmithKline’s Nucala.

Trials

Trials FDA Approval Hormones Drugs

Clinical Research Informer

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

COVID-19 and Melatonin: Researchers Use AI To Study New Treatment Option

Trending Sources

Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

Top 40 Best-Selling Cancer Drugs in 2023 by 2022 Data

World Lupus Day 2023 and Novel Investigational Drugs for Lupus

2020 review – Pharma’s progress outside of COVID-19

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

AstraZeneca’s Fasenra Shown to Eliminate Steroid Use in Asthma Patients

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