XTalks

FEBRUARY 3, 2023

Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. This approval follows the promising results of the Phase III EMERALD global clinical trial published in the Journal of Clinical Oncology.

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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. The results still require further validation, including experimental and clinical evaluation. The list also included melatonin.

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XTalks

NOVEMBER 10, 2021

The trials are part of GSK’s Phase III ASCEND (Anaemia Studies in Chronic Kidney Disease: Erythropoiesis via a novel prolyl hydroxylase inhibitor Daprodustat) program for daprodustat, and interim results from the studies were presented at the American Society of Nephrology’s Kidney Week 2021. What is Daprodustat? percent for darbepoetin alfa.

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Trials Hormones Drugs FDA Approval 97

XTalks

JUNE 10, 2024

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. It can lead to inflammation, fibrosis, cirrhosis, liver failure and potentially death. MASH is intricately linked to cardiovascular, kidney and metabolic disorders.

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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. These types of treatments represent the goal of precision medicine , where therapies are tailored to specific patient types. Tafinlar and Mekinist Combination Clinical Trial Results.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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STAT News

DECEMBER 5, 2022

… Johnson & Johnson said it does not intend to make an offer for Horizon Therapeutics, days after the developer of medicines for rare autoimmune and inflammatory diseases revealed it was in talks with the company , Bloomberg News writes. regulatory approval, Bloomberg News says. We treasure every new pen pal.

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The Pharma Data

JUNE 24, 2021

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. About TALAPRO-3 Trial.

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DNA Clinical Trials Clinical Trials Trials 52

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. The company is currently preparing for further clinical trials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

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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

pharmaphorum

DECEMBER 23, 2020

But there was some considerable progress in other fields of medicine even though research efforts were diverted away, reports Richard Staines. In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1 months, compared with 6.7 months in patients treated with chemotherapy. Neurology on the march.

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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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XTalks

AUGUST 10, 2022

In the US, it is estimated that 287,850 new cases of female breast cancer will be diagnosed in 2022, according to data from the National Cancer Institute (NCI) outlined by the FDA. Enhertu Trial Data. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

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XTalks

APRIL 29, 2022

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.

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The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials.

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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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Pharmaceutical Technology

MARCH 2, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

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The Pharma Data

APRIL 4, 2023

The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. The ongoing Phase 3 EV-302/KEYNOTE-A39 trial evaluating the clinical benefit of KEYTRUDA in combination with enfortumab vedotin in patients with previously untreated advanced urothelial cancer is intended to serve as the U.S.

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Intouch Solutions

AUGUST 5, 2021

This then leads many of those same people to online forums like the TransDIY subreddit that’s dedicated to do-it-yourself hormone replacement therapy, or DIY HRT. DIY HRT is a combination of non-prescribed, often unregulated, hormone medicines and self-performed surgeries that are administered without the supervision of an HCP.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. are common ?during

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XTalks

DECEMBER 22, 2021

We talked about the emergence of dozens of CRISPR biotechs last year and the growing number of CRISPR-based therapies in clinical trials for conditions ranging from Duchenne muscular dystrophy (DMD) and sickle cell disease (SCD). Patients can also communicate with their providers more often from the comfort of their own home.

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The Pharma Data

JUNE 18, 2021

. “With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking,” said Arnon Kater , M.D., deputy head of hematology, University of Amsterdam Faculty of Medicine. About VENCLEXTA ® /VENCLYXTO ® (venetoclax).

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Medicine Production FDA Approval Trials 52

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinical trials. The safety profile was consistent with prior studies of ERLEADA ® , with no new safety signals observed.

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The Pharma Data

JULY 23, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. “The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.” Barr , M.D., 1 Additionally, at 6.5

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The Pharma Data

MARCH 11, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. To date, the Opdivo clinical development program has treated more than 35,000 patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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Trials Hormones Genome Genomics 52

The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. About Opdivo. Immune-Mediated Pneumonitis.

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Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. About Opdivo. Immune-Mediated Pneumonitis.

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The Pharma Data

JUNE 28, 2021

” Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes.

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The Pharma Data

MAY 4, 2021

Internal Medicine. The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Clinical and Research Developments. REVENUES. . . . . . ($ in millions). First-Quarter. .

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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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XTalks

MAY 20, 2022

Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial. Like Mounjaro, Novo Nordisk’s Ozempic is also a GLP-1 receptor agonist and in a head-to-head trial last year, Lilly’s drug trumped Novo’s.

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