Clinical Development, Drugs, FDA Approval and Hormones

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S. NYSE: PFE) and OPKO Health Inc.

Hormones

Hormones FDA Approval Clinical Development Medicine

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. The drug is injected under the skin once a week and the dose can be adjusted to meet an individual’s blood sugar needs.

FDA Approval

FDA Approval Insulin Drugs Hormones

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., For the U.S.

FDA Approval

FDA Approval HR Trials Hormones

Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

Antibody

Antibody Marketing Drugs Licensing

Merck’s Keytruda flunks another prostate cancer test

pharmaphorum

JANUARY 26, 2023

Merck has said it will abandon the KEYNOTE-991 study of PD-1 inhibitor Keytruda (pembrolizumab) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after it showed no benefit on either overall survival (OS) or radiographic progression-free survival (rPFS) when the data was analysed midway though.

Hormones

Hormones Trials FDA Approval Clinical Development

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

FDA Approval

FDA Approval Gene Hormones Licensing

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

FDA Approval

FDA Approval Manufacturing Drugs Pharmacy

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

OCTOBER 14, 2020

. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Drug Enforcement Administration. Drug Enforcement Administration.

FDA Approval

FDA Approval Hormones Production Drugs

2020 review – Pharma’s progress outside of COVID-19

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

Marketing Gene Silencing Gene Drugs

Enough Of Wasting Away From Cancer: Companies Gear Up To Tackle Cachexia

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Earlier clinical evidence showcased administration of the therapy resulted in a statistically significant and dose-proportional increase in body weight.

Marketing

Marketing Pharma Companies Development 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. It was also given FDA priority review. billion to $1.28

HR

HR FDA Approval Gene Trials

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

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

Sales Manufacturing FDA Approval Life Science

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). According to GlobalData, Phase III drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

FDA Approval

FDA Approval Containment Development Genome

Where are the advances in treatments for triple-negative breast cancer?

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited.

Protein

Protein Trials Clinical Trials Clinical Trials

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. Consider monitoring more frequently as compared to when the drugs are administered as single agents.

FDA Approval

FDA Approval Containment Hormones Dermatology

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

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

Hormones Trials Genome Genomics

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

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

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CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Clinical Trials Clinical Trials

Clinical Research Informer

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

Trending Sources

FDA Approves

Three trends in the antibody-drug conjugate (ADC) market

Merck’s Keytruda flunks another prostate cancer test

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

2020 review – Pharma’s progress outside of COVID-19

Enough Of Wasting Away From Cancer: Companies Gear Up To Tackle Cachexia

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

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

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

Where are the advances in treatments for triple-negative breast cancer?

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

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

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