Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 88

FDA Approval Drugs Trials Development 88

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 52

FDA Approval HR Trials Hormones 52

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 68

FDA Approval Drugs Trials Development 68

Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Drug Discovery World

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). The post FDA approves gene therapy for rare neurological disorder appeared first on Drug Discovery World (DDW).

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Gene Therapy FDA Approval Gene Clinical Trials 52

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. Related: Nerivio: New Drug-Free Wearable Technology Used to Treat Migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.

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Development Drugs FDA Approval Clinical Development 162

Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

FDA Approval 72

FDA Approval Branding Development Drugs 72

Outsourcing Pharma

DECEMBER 18, 2023

The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).

FDA Approval 82

FDA Approval Branding Development Drugs 82

Outsourcing Pharma

NOVEMBER 16, 2023

The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.

FDA Approval 74

FDA Approval Drugs Clinical Development Development 74

Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

FDA Approval 94

FDA Approval Clinical Trials Clinical Trials Trials 94

BioPharma Reporter

AUGUST 2, 2021

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.

FDA Approval 98

FDA Approval Drugs Clinical Development Development 98

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

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FDA Approval Clinical Development Drugs Medicine 130

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. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.

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Hormones FDA Approval Clinical Development Medicine 40

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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FDA Approval HR Vaccination Vaccine 40

Outsourcing Pharma

SEPTEMBER 18, 2023

The small molecule drug Ojjaara (momelotinib), developed by GlaxoSmithKline, has become the first U.S. Food and Drug Administration (FDA)-approved treatment for patients with the blood cancer myelofibrosis and anemia.

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FDA Approval Development Drugs Clinical Development 80

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Development Drugs Clinical Trials Clinical Trials 147

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

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FDA Approval Drugs Clinical Development Medicine 40

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.

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Antibody Marketing Drugs Licensing 98

The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

pharmaphorum

MAY 30, 2022

For decades, RAS has existed as an elusive therapeutic target, and drugging this high-value oncogene was deemed impossible. Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions.

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Development Drugs FDA Approval Clinical Trials 52

pharmaphorum

FEBRUARY 21, 2022

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson.

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Drugs Trials Insulin FDA Approval 121

XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

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FDA Approval Drugs Antibody Medicine 52

Roots Analysis

DECEMBER 18, 2023

The next generation drug conjugate is relatively a new concept. This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Endocyte also developed other small molecule drug conjugates for the treatment of cancer and renal disorders.

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Drugs FDA Approval Antibody Development 40

Roots Analysis

MARCH 9, 2023

In recent years, several drugs targeting rare kidney disorders have received the FDA approval; therapies in the current pipeline are being developed to target ~15 disease indications. The below figure presents the distribution of drugs indicated for rare kidney disorder, based on their phase of development.

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Drugs FDA Approval Marketing Development 52

The Pharma Data

JANUARY 6, 2021

The research collaboration is aimed at identifying novel lead compounds and repurposing existing drugs for rheumatoid arthritis and nonalcoholic steatohepatitis, leveraging Standigm’s AI-powered drug discovery platforms : Standigm BEST , Standigm Insight , and Standigm ASK. Standigm is an AI-driven drug discovery company.

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FDA Approval Life Science Drugs In-Vivo 52

The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 5, 2022

The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.

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FDA Approval DNA Clinical Trials Clinical Trials 147

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MARCH 1, 2023

The FDA approval of Sarepta’s Exondys 51 to treat Duchenne muscular dystrophy (DMD) and the approval of Ionis’ Spinraza to treat spinal muscular atrophy (SMA) in 2016 marked critical milestones in the field, as the first ASO drugs to enter the market.

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RNA Vaccination Vaccine Genetics 147

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Posted: November 2020.

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Clinical Development Vaccination Vaccine Development 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., OPHTHALMIC ADVERSE REACTIONS.

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

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Drugs Antibody Pharma Companies Development 94

The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. TAIPEI, Taiwan , Nov. 1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S.

FDA Approval 52

FDA Approval Marketing Clinical Development Development 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is a new molecular entity (NME).

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Recombinant DNA Technology Production Antibody FDA Approval 100

The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). ” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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FDA Approval Production Trials Clinical Trials 52