pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.

FDA Approval 101

FDA Approval Insulin Drugs Hormones 101

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.

Life Science 52

Life Science Trials FDA Approval Hormones 52

XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

Pharmaceutical Technology

JUNE 1, 2023

In addition, the FDA previously rejected Intercept’s OCA NDA, with the federal agency issuing a complete response letter (CRL) requesting longer-term post-interim analysis efficacy and safety data from the ongoing pivotal Phase III REGENERATE trial (NCT02548351) in June 2020. risk reduction compared with placebo).

Clinical Trials 130

Clinical Trials Clinical Trials Trials Hormones 130

Drug Discovery World

DECEMBER 22, 2022

It had already received FDA approval for the United States in March of this year. The approval is limited to patients who had previously received chemotherapy and who do not respond to hormone withdrawal. . Men with advanced prostate cancer currently have hardly any promising treatment options.

Drugs 52

Drugs Clinical Trials Clinical Trials Hormones 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.

Clinical Trials 97

Clinical Trials Clinical Trials FDA Approval Trials 97

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal. Acromegaly.

Trials 98

Trials Gene Hormones Clinical Trials 98

pharmaphorum

DECEMBER 1, 2021

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

Vaccination 90

Vaccination Vaccine Development Hormones 90

pharmaphorum

FEBRUARY 1, 2021

If approved by the European Commission in the coming weeks, Kesimpta will offer patients with relapsing disease a treatment option that can be self-administered every month through an auto-injector pen.

Drugs 95

Drugs Hormones FDA Approval Licensing 95

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.

FDA Approval 52

FDA Approval In-Vivo Gene Editing Drugs 52

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. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

FDA Approval 52

FDA Approval Medicine Clinical Trials Clinical Trials 52

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 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

Sales 52

Sales Insulin FDA Approval Drugs 52

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. Recent results from Phase III clinical studies support the duo’s regulatory submission for somatrogon.

Hormones 52

Hormones FDA Approval Trials Drugs 52

XTalks

NOVEMBER 10, 2021

GlaxoSmithKline (GSK) unveiled positive safety and efficacy data for its oral anemia drug daprodustat from five pivotal trials for the drug last week. The topline results hold even more significance after the rejection of AstraZeneca and FibroGen’s oral anemia med roxadustat by the US Food and Drug Administration (FDA) in August.

Trials 97

Trials Hormones Drugs FDA Approval 97

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.

Research 98

Research Hormones Protein Regulation 98

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 52

FDA Approval Hormones Production Drugs 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. Tafinlar and Mekinist Combination Clinical Trial Results. The safety and efficacy of the Tafinlar and Mekinist combination therapy was evaluated in three clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

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. Lupkynis was the first FDA-approved oral medication specifically indicated for the treatment of LN. It works by suppressing the immune system and decreasing inflammation in the kidneys.

Drugs 52

Drugs Clinical Trials Clinical Trials Antibody 52

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. MASH is intricately linked to cardiovascular, kidney and metabolic disorders.

Insulin 52

Insulin Life Science Regulation Hormones 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.

FDA Approval 101

FDA Approval Drugs Sales Development 101

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.

DNA 52

DNA Clinical Trials Clinical Trials Trials 52

Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. CDK4/6 inhibitors are used alongside hormone therapy. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

Development 52

Development DNA Clinical Trials Clinical Trials 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. The company is currently preparing for further clinical trials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

Marketing 94

Marketing Pharma Companies Development Hormones 94

STAT News

DECEMBER 5, 2022

Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market , The Wall Street Journal notes. Supreme Court decision overturning Roe v.  Pluvicto is already cleared in the U.S.

Insulin 52

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.

FDA Approval 52

FDA Approval Drugs Sales Development 52

Drug Discovery World

APRIL 23, 2024

Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. Concussive injuries have been overlooked and as a consequence, clinical trials for novel therapeutic approaches are just starting to appear.

Drugs 59

Drugs Development Life Science Hormones 59

Delveinsight

DECEMBER 7, 2020

Development in the technology has made it possible for solutions to surface, primarily related to R&D, clinical trials, and diagnostics and treatment, as well as patient management, leading to even more significant innovative potential and promise for AI in the industry.

Protein 56

Protein Insulin Hormones FDA Approval 56

pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. months, compared with 6.7 months in patients treated with chemotherapy.

Marketing 75

Marketing Gene Silencing Gene Drugs 75

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.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

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.

Hormones 95

Hormones FDA Approval Drugs Clinical Trials 95

XTalks

FEBRUARY 19, 2021

Evofem Biosciences announced the launch of their new national campaign called, “Get Phexxi,” designed to raise awareness about the company’s non-hormonal birth control method. In May 2020, the US Food and Drug Administration (FDA) approved Phexxi , a non-hormonal contraceptive for women.

Hormones 88

Hormones Production FDA Approval Marketing 88

XTalks

NOVEMBER 9, 2022

Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. The obesity drug market is currently valued at $2.82 billion in 2021 to $61.6

Insulin 98

Insulin Hormones FDA Approval Sales 98

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.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

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

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

HR 98

HR FDA Approval Gene 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]. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials.

HR 52

HR Hormones Development Production 52

The Pharma Data

AUGUST 31, 2021

Prostate-Specific AntigenKinetics in Patients from TITAN and SPARTAN (oral presentation): Post-hoc analysis of PSA kinetics in 1,331 patients treated with ERLEADA ® from both the TITAN and SPARTAN trials (Abstract #PD34-11). 2] ERLEADA ® received U.S. For more information, visit www.ERLEADA.com.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Trials Drugs 52