FDA Approval, Research Laboratories and Treatment

FDA Approves

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S.,

FDA Approval

FDA Approval FDA Therapies Treatment

Cancer vaccine shows sustained improvement in survival rates

Drug Discovery World

JUNE 6, 2024

months after initial treatment. Moderna recently secured FDA approval for the first mRNA vaccine to treat something other than Covid-19 – it’s respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345). Ultimately it will contribute to survival rates improving continually over the next decades and more.”

Vaccine

Vaccine Clinical Trials FDA Approval Research Laboratories

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

FDA Approval

FDA Approval Treatment FDA Research Laboratories

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. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

FDA Approval

FDA Approval FDA Hospitals Treatment

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).

FDA

FDA FDA Approval Trials Treatment

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

FDA

FDA Licensing Licensing FDA Approval

VERQUVO® (vericiguat) Approved in the European Union

The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

Treatment

Treatment Production FDA Approval Hospitals

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

JULY 22, 2021

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation.

Therapies

Therapies Treatment Disease Trials

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events.

Research

Research Treatment Therapies Trials

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

JULY 8, 2021

KEYTRUDA Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation. This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KENILWORTH, N.J.–(BUSINESS

FDA Approval

FDA Approval FDA Treatment Therapies

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

Hospitals

Hospitals Treatment Long-Term Care Facilities Trials

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

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. We are committed to putting patients first and continuing our research to help advance new approaches to potentially extend the lives of people with cancer.

Treatment

Treatment FDA Approval FDA Therapies

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

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. This indication is approved under accelerated approval based on tumor response rate and durability of response.

Treatment

Treatment FDA Approval FDA Therapies

Merck Provides Update on KEYTRUDA® (pembrolizumab) Indication in Third-Line Gastric Cancer in the US

The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] 1)] as determined by a U.S. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

FDA Approval

FDA Approval FDA Treatment Therapies

LYNPARZA® (olaparib) in Patients with Metastatic Castration-Resistant Prostate Cancer to Stop for Futility

The Pharma Data

MARCH 15, 2022

Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. Merck continues to evaluate the combination of KEYTRUDA and LYNPARZA in a range of cancers, and to research other KEYTRUDA-based combinations for patients with advanced prostate cancer.

DNA

DNA Clinical Trials Trials Therapies

Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

The Pharma Data

MARCH 30, 2021

In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) ? About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

FDA Approval

FDA Approval FDA Treatment Therapies

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

The Pharma Data

JULY 15, 2021

Given the high rates of recurrence within the first five years of diagnosis, patients with high-risk early-stage TNBC need new treatment options,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. KEYTRUDA is currently approved under accelerated approval in the U.S.

Therapies

Therapies Treatment Trials FDA

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Nature Neuroscience. Read You love to see it! Press release.

DNA

DNA RNA Engineering Licensing

The Promise of Gas Vesicles

Codon

JUNE 18, 2024

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

Engineering

Engineering Laboratories International Clinical Trials

Drug Discovery Digest

FDA Approves

Cancer vaccine shows sustained improvement in survival rates

Trending Sources

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced 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

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

VERQUVO® (vericiguat) Approved in the European Union

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

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

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Merck Provides Update on KEYTRUDA® (pembrolizumab) Indication in Third-Line Gastric Cancer in the US

LYNPARZA® (olaparib) in Patients with Metastatic Castration-Resistant Prostate Cancer to Stop for Futility

Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

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

Codon Digest: Injected Gene Editors

The Promise of Gas Vesicles

Stay Connected