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FDA Approves

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.,

FDA Approval

FDA Approval HR Trials Hormones

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

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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Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Trending Sources

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

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.

FDA Approval

FDA Approval Production RNA Medicine

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Bridging Innovation & Patient Care: The Growing Role of AI

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Pembrolizumab by Merck for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). GlobalData’s report assesses how Pembrolizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

FDA Approval

FDA Approval Containment Development Genome

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

The Pharma Data

FEBRUARY 24, 2022

– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. vice president, Product Development, Lilly.

FDA Approval

FDA Approval Medicine Trials HR

Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

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).

HR FDA Approval Trials DNA

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

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.

HR FDA Approval Containment Genome

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

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]; 0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. KEYTRUDA is currently approved under accelerated approval in the U.S.

HR Trials Clinical Development Clinical Research

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

SEPTEMBER 9, 2020

In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; Roche’s Chief Medical Officer and Head of Global Product Development. ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S.

Antibody

Antibody Medicine In-Vitro HR

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

The Pharma Data

JUNE 26, 2021

In the overall study population, Libtayo significantly reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy (hazard ratio HR: 0.68; 95% confidence interval CI: 0.53-0.87; 0.87; p=0.0022).

Trials

Trials Genetics Antibody HR

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) mg/kg) is also approved in the U.S. NR] versus 3.9

Medicine

Medicine Trials Antibody HR

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). Senior Vice President and Head of Global Clinical Development at Regeneron. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody

Antibody Trials Production Clinical Trials

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

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

FDA Approval

FDA Approval Production Trials Development

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

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).

FDA Approval

FDA Approval HR Trials Drugs

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales

Sales Manufacturing FDA Approval Life Science

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

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]

FDA Approval

FDA Approval HR Vaccination Vaccine

FDA Approves

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

Webinars

Trending Sources

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

Webinars

Pembrolizumab by Merck for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

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