Clinical Development, Development, 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

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

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

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.

FDA Approval

FDA Approval Insulin Drugs Hormones

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

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval

FDA Approval Gene Hormones Licensing

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

Drug Discovery World

JUNE 1, 2023

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. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

Antibody

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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

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“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. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

FDA Approval

FDA Approval Hormones Production Drugs

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

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. The company is currently preparing for further clinical trials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

Marketing

Marketing Pharma Companies Development Hormones

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

pharmaphorum

DECEMBER 23, 2020

Originally developed to treat late-stage EGFR-mutated disease, the ADAURA study tested Tagrisso as an adjuvant treatment in patients with early disease following surgery. A molecule codenamed DNL151, currently in phase 1 development, has been selected to progress into late-stage clinical studies that are expected to begin in 2021.

Marketing

Marketing Gene Silencing Gene Drugs

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

HR

HR FDA Approval Gene Trials

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. Buy the report here.

FDA Approval

FDA Approval Containment Development Genome

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

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc.

Sales

Sales Manufacturing FDA Approval Life Science

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

Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Initiate hormone replacement as indicated. Withhold KEYTRUDA depending on severity.

FDA Approval

FDA Approval Containment Hormones Dermatology

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

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

The Pharma Data

JULY 23, 2021

For the past three and a half years, Opdivo monotherapy has been an important option that physicians have relied on to address this need and is currently the most commonly used therapy in the post-sorafenib setting,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb.

Hormones

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

The Pharma Data

MARCH 11, 2021

“We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. development lead, gastrointestinal cancers, Bristol Myers Squibb. “In Waxman, M.D.,

Trials

Trials Hormones Genome Genomics

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

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. Waxman, M.D.,

Trials

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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

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “We We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials

Trials Hormones Clinical Trials Clinical Trials

Tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes

The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. GIP is a hormone that may complement the effects of GLP-1. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

Insulin

Insulin Clinical Trials Clinical Trials Hormones

Clinical Research Informer

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

FDA Approves

Trending Sources

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

Merck’s Keytruda flunks another prostate cancer test

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

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

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

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

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

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

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

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

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

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

Where are the advances in treatments for triple-negative breast 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

Tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes

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