XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. to 4,437 yen, reflecting investor confidence.

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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. Findings of the study, reported at the ESMO Congress 2022, demonstrated a 3.2-month months) versus physicians’ choice chemotherapy (11.2

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BioPharma Reporter

SEPTEMBER 19, 2024

Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive, HER2-negative) stage two or three early breast cancer, who are at high risk of cancer recurrence.

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BioSpace

NOVEMBER 16, 2023

The company's Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

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pharmaphorum

FEBRUARY 25, 2022

“Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately three million adults in the US with preserved ejection fraction, a form of heart failure that has very limited treatment options.” absolute risk reduction, 0.79

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Medical Xpress

JANUARY 31, 2025

Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

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XTalks

JANUARY 30, 2025

Novartis has spent three decades advancing breast cancer treatments, focusing on hormone receptor-positive (HR+), HER2-negative breast cancer, the most common subtype. Last year, the FDA approved Kisqali (ribociclib) to reduce the risk of recurrence in HR+/HER2- early breast cancer.

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Pharmaceutical Technology

JUNE 4, 2023

in the placebo arm (hazard ratio [HR]: 0.58). months in the placebo arm (HR: 0.73). In March 2022, the FDA approved Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for use in the neoadjuvant setting, giving it the first-to-market-advantage, based on results from the Phase III CHECKMATE-816 study.

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The Pharma Data

JUNE 2, 2023

Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59]) Based on exploratory analyses of rPFS and OS in the BRCA m and non- BRCA m subgroups (non- BRCA subgroup rPFS HR=0.77 [95% CI, 0.63-0.96]; In the U.S.,

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Pharmaceutical Technology

MARCH 6, 2023

months for the chemotherapy arm (hazard ratio [HR]: 0.52). While the data will be presented at an upcoming meeting, a previous analysis of the two arms for OS showed an HR of 0.59, which could lead to a modest but clinically meaningful improvement in OS. At a median follow-up of 22.1 months, the PFS for the Tuoyi arm was 21.4

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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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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

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

FEBRUARY 24, 2022

– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. ” “This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure,” said Jeff Emmick, M.D.,

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pharmaphorum

JANUARY 28, 2021

There is also current legislation in Congress (HR 8190) that aims to open the door to interchangeability within the biosimilar market – specifically starting with insulin products. If passed, HR 8190 would allow insulin biosimilar products to receive automatic interchangeability upon FDA approval.

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XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. What does this Approval Mean for Breast Cancer Patients? months in HR+/HER2- Patients The average five-year rate of survival is 30 percent in HR+/HER2- patients.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Verquvo met the primary efficacy objective based on a time-to-event analysis (hazard ratio [HR]: 0.90, 95% confidence interval [CI], 0.82-0.98; Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. With today’s FDA approval of TALZENNA plus XTANDI, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.” 0.61; p<0.0001).

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The Pharma Data

NOVEMBER 18, 2021

The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); 0.87); p = 0.0010) compared to placebo. 0.87); p = 0.0010).

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pharmaphorum

JANUARY 26, 2023

In Europe, approximately 531,000 breast cancer patients are diagnosed annually, with around 141,000 deaths, and around half of all cases would fall under the HER2-low classification, split between patients with both hormone receptor (HR) positive and HR negative disease. months to 23.4

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The Pharma Data

APRIL 20, 2023

FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. 0.95; p<0.02). versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 13.0%).

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XTalks

MARCH 25, 2021

She also writes informative blogs on topics including drug development, life science company profiles and HR content pertaining to the pharma and biotech industries. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences.

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pharmaphorum

OCTOBER 11, 2020

When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.

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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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FDA Approval Drugs Sales Development 52

The Pharma Data

JULY 29, 2021

SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). 3 surgeries) and were in need of further surgery due to severe symptoms and increased size of their polyps.

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FDA Approval Clinical Trials Clinical Trials Trials 52

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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XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. billion Company: Pfizer Diseases it is FDA-approved to treat: COVID-19 Cost: The price of Paxlovid oral tablet is around $10 for a supply of 30 tablets.

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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The Pharma Data

APRIL 8, 2022

This analysis reported after a median follow-up of three years, LORBRENA continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR), the primary endpoint, compared to XALKORI (HR, 0.27; 95% CI, 0.18–0.39), LORBRENA is approved in the U.S.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

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HR FDA Approval Containment Genome 52

pharmaphorum

FEBRUARY 14, 2022

If positive, that study could form the basis of an application for accelerated FDA approval in first-line UC, as Astellas and Seagen run a phase 3 programme of Padcev in an all-comer frontline UC population, regardless of cisplatin eligibility, in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab).

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The Pharma Data

AUGUST 22, 2021

1 Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo (Hazard Ratio [HR] 0.70, 95% CI: 0.57 n=142) for placebo; Opdivo reduced the risk of disease recurrence or death by 45% (HR 0.55, 95% CI: 0.39 months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]). to 0.86; P =0.0008).

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The Pharma Data

APRIL 7, 2021

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

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The Pharma Data

JULY 15, 2021

After a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; KEYTRUDA is currently approved under accelerated approval in the U.S. 10) as determined by an FDA-approved test. 1.02]; p=0.03214). 0.92]) versus the chemotherapy-placebo regimen.

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