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

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 93

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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Drugs Hormones FDA Approval Clinical Trials 98

XTalks

MAY 26, 2022

In this episode, Ayesha discussed the FDA approval 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).

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

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Research Hormones Protein Regulation 98

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 10, 2021

The results were also published in the New England Journal of Medicine at the same time. Related: GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer. Kidney dysfunction in CKD leads to impaired production of the hormone, particularly in more advanced disease. What is Daprodustat? percent for darbepoetin alfa.

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Trials Hormones Drugs FDA Approval 97

The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The approval of INVEGA HAFYERA™ builds on our 60-year legacy of delivering transformational medicines for adults living with schizophrenia,” said Mathai Mammen, M.D., INDICATION.

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XTalks

OCTOBER 25, 2023

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 FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

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Life Science Trials FDA Approval Hormones 52

XTalks

JULY 19, 2024

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. Moreover, 15 percent of flagged ads offer the medication without the need of a prescription.

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Pharmacy Drugs Production Sales 104

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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Clinical Trials Clinical Trials FDA Approval Trials 97

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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The Pharma Data

AUGUST 17, 2021

Also tell your doctor: about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements. about any other prescription medicines you take, especially ones called TZDs. drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog. Before using.

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Insulin FDA Approval Doctors Doctor 52

XTalks

SEPTEMBER 6, 2024

In a press release announcing the new sites, Novartis said it is also planning for a third site in the US “to support expanded use of radioligand therapies, create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast.”

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Development Manufacturing Marketing Hormones 105

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. The biotech isn’t revealing how much it intends to charge for the new medicine, saying it will do so closer to launch later this year.

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Dermatology Drugs Hormones FDA Approval 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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HR Hormones FDA Approval Antibody 52

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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Sales Hormones Marketing FDA Approval 59

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.

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FDA Approval Gene Hormones Drugs 52

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Cachexia is a complex metabolic syndrome, which is characterized by the loss of fat and muscles in the body.

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Marketing Pharma Companies Development Hormones 94

XTalks

MARCH 8, 2024

Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most,” said Keren Haruvi, president, Sandoz North America, in a statement from the company.

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Drugs FDA Approval Production Immune Response 59

The Pharma Data

MAY 13, 2021

Well, sleep keeps the “hunger hormones” (ghrelin and leptin) in check. When you don’t get enough sleep, you create an imbalance between these hormones and that leads to an increased appetite which, in turn, will put your weight loss journey to a halt. Well, sleep keeps the “hunger hormones” (ghrelin and leptin) in check.

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Hormones Production Packaging Packaging 52

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.

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FDA Approval Manufacturing Drugs Pharmacy 59

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. There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class.

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Marketing Gene Gene Silencing Drugs 78

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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Insulin Life Science Regulation Hormones 52

The Pharma Data

AUGUST 30, 2021

Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

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Medicine Antibody Hormones Development 52

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.

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Clinical Trials Clinical Trials Trials Gene 52

The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

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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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FDA Approval Drugs Sales Development 101

XTalks

DECEMBER 22, 2021

Sarepta Therapeutics has been focused on developing AOS for the treatment of DMD and has received FDA approvals for three of its compounds — EXONDYS 51 (eteplirsen), VYONDYS 53 (golodirsen) and AMONDYS 45 (Casimersen), which are based on exon skipping. Minimally Invasive Devices.

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Life Science RNA Vaccine Vaccination 98

Pfizer

JANUARY 27, 2023

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

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Research Vaccine Vaccination Drugs 112

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. “We

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Medicine In-Vitro Antibody Development 40

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. 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.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

JUNE 18, 2021

deputy head of hematology, University of Amsterdam Faculty of Medicine. 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. About VENCLEXTA ® /VENCLYXTO ® (venetoclax).

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Medicine Production FDA Approval Trials 52

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]. New England Journal of Medicine. About ERLEADA ® (apalutamide). 3] Chi, K.

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HR Hormones Development Production 52

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. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated.

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Hormones Trials Genome Genomics 52

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. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated.

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Trials Hormones Genome Genomics 52

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. Tell your healthcare provider about all the medicines you take, ?including and for 1 week after the last dose. . are common

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Medicine Production FDA Approval Trials 40