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

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 85

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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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 96

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 52

FDA Approval Gene Hormones Licensing 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

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

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 FDA Approval Marketing 57

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 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 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

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

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

Drug Discovery World

JUNE 1, 2023

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. DDW’s Megan Thomas explores three trends in the market.

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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.

Hormones 52

Hormones Production Packaging Packaging 52

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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Insulin Manufacturing Medicine Drugs 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 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 Regulation 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

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 FDA Approval 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.,

DNA 52

DNA Clinical Trials Clinical Trials Trials 52

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. 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 Silencing Gene Drugs 74

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

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. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

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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.

Insulin 52

Insulin FDA Approval Doctors Doctor 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.

HR 52

HR Hormones FDA Approval Antibody 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. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

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.

HR 52

HR Hormones Development Production 52

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

It is under development for the treatment of spindle cell squamous cell carcinoma, giant cell carcinoma, gastroenteropancreatic neuroendocrine tumor (GEP-NETs), extrahepatic bile duct cancer, colon tumor, rectal tumor, cervical cancer, vulvar cancer.

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FDA Approval Containment Development Genome 100

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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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JULY 22, 2021

This FDA approval of KEYTRUDA plus LENVIMA for the treatment of patients with certain types of advanced endometrial cancer is an important step forward towards helping this patient community that has had limited treatment options,” said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai.

HR 52

HR Trials Dermatology Hormones 52

The Pharma Data

APRIL 4, 2023

The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. confirmatory trial for the accelerated approval. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Initiate hormone replacement as indicated. Rahway, NJ, USA.

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FDA Approval Containment Hormones Dermatology 40

The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

FDA Approval 52

FDA Approval Hormones Trials Medicine 52

The Pharma Data

AUGUST 3, 2021

. “As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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Sales Production Antibody Development 52

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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