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 52

FDA Approval Drugs Sales Development 52

pharmaphorum

JULY 19, 2022

Merck said the LYNK-003 rial of Lynparza (olaparib) given as either a monotherapy or in combination with Roche’s CD20-targeting antibody Avastin (bevacizumab) in advanced colorectal cancer has been halted, as a look at the unblinded data showed little chance of a positive result.

Trials 52

Trials Hormones FDA Approval Drugs 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

pharmaphorum

DECEMBER 23, 2020

The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year.

Marketing 97

Marketing Gene Silencing Gene Drugs 97

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Phase II randomised, double-blind, placebo-controlled study demonstrated that the drug as well-tolerated and a higher dose even helped in gaining weight.

Marketing 94

Marketing Pharma Companies Development Hormones 94

Find Me Cure

OCTOBER 13, 2019

Drugs and therapies under study are our hope for the future of healthcare, so taking the time to learn more about them is an investment in your future health as well as the background education you need to make informed decisions about your treatment. CDK4/6 inhibitors are used alongside hormone therapy.

Development 52

Development DNA Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

Trials 98

Trials Gene Hormones Clinical Trials 98

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

HR 264

HR Hormones FDA Approval Antibody 264

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 drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

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. About Tecentriq. receptors. Source link: [link].

Medicine 52

Medicine Antibody 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.

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

HR 98

HR FDA Approval Gene Trials 98

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

AUGUST 31, 2021

Additionally, Janssen will present an update on the Phase 3 SunRISe-2 trial evaluating an investigational intravesical drug delivery system, TAR-200, in combination with the programmed cell death receptor-1 (PD-1) inhibitor cetrelimab in muscle-invasive urothelial carcinoma (Abstract # MP13-17). [1]. DRUG INTERACTIONS. About TAR-200.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Trials Drugs 52

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. receptors. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: [link].

Medicine 40

Medicine In-Vitro Antibody Development 40

The Pharma Data

AUGUST 3, 2021

For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. Cost of Sales margin increased 1.6 Tax Rate increased 5.6 In May, the U.S.

Sales 52

Sales Production Antibody Development 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

HR 162

HR Marketing Hormones FDA Approval 162

XTalks

NOVEMBER 2, 2020

Fasenra was approved in 2017 as an add-on treatment for patients aged 12 years and older with severe asthma (specifically, severe eosinophilic asthma) in the US, EU, Japan and other countries to reduce events of worsening symptoms. Related: Dexamethasone Becomes First Drug Shown to Reduce COVID-19-Related Mortality. PONENTE Trial.

Trials 94

Trials FDA Approval Hormones Drugs 94

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Consider monitoring more frequently as compared to when the drugs are administered as single agents.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

APRIL 7, 2021

Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. FOSTER CITY, Calif.–(BUSINESS

HR 52

HR Genotype FDA Approval Genotoxicity 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

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. In consultation with the U.S.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. Immune-Mediated Endocrinopathies.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. Secondary endpoints include safety and overall survival. About tiragolumab.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. 2010; 116(20): 4777–4787.

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Institute hormone replacement therapy for endocrinopathies as warranted.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Institute hormone replacement therapy for endocrinopathies as warranted.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. Drug Interactions.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination 40

Vaccination Vaccine Production Sales 40