Chemical Biology and Drug Design

NOVEMBER 20, 2023

We employed a combined strategy involving molecular docking-based virtual screening, molecular dynamics (MD) simulation, and MM/GBSA free energy calculation on existing FDA-approved drugs. Sorafenib and glimepiride simultaneously downregulated c-Maf protein expression to induce G1 phase arrest and apoptosis in myeloma cells.

Small Molecule 100

Small Molecule Protein Expression FDA Approval FDA 100

Covalent Modifiers

APRIL 28, 2023

Food and Drug Administration (FDA) approved small molecules. Consequently, these studies are facilitating resources for closing the druggability gap, namely, achieving pharmacological manipulation of ∼96% of the human proteome that remains untargeted by U.S.

Small Molecule 130

Small Molecule FDA Approval FDA Disease 130

Dark Matter Blog

AUGUST 27, 2020

A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with small molecules. The agent, onasemnogene abeparvovec, was approved by the FDA in 2019 and is marketed as Zolgensma. But we have not been the only people on this mission.

Small Molecule 52

Small Molecule RNA Clinical Trials Drugs 52

The Pharma Data

JANUARY 19, 2021

Precision medicine developer Kura Oncology is positioned to make a meaningful difference in the treatment of cancer in the next few years with its two, wholly-owned, small molecule compounds. Photo courtesy of Kura. It’s in the spotlight, the data is stunning, and it has a lot of promise,” Troy Wilson, Ph.D., CEO, told BioSpace.

Small Molecule 52

Small Molecule Therapies FDA Approval Trials 52

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Vlad Coric , M.D.,

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

Fierce BioTech

MARCH 11, 2024

Safety Considerations for the Development of ADCs dwunderlin Mon, 03/11/2024 - 16:44 Tue, 04/30/2024 - 11:00 Resource Type Webinar Maciej Czerwinski, PhD Duration 60 Minutes Antibody-drug conjugates (ADCs) are a novel modality leveraging monoclonal antibody (mAb)-mediated delivery of a cytotoxic payload molecule to its target.

Small Molecule 52

Small Molecule FDA Approval FDA Treatment 52

PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998.

Treatment 71

Treatment FDA Approval DNA Small Molecule 71

KIF1A

JULY 1, 2023

Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning. But we may find that we have a wealth of potential small molecule solutions for newly recognized disorders, just waiting to be rediscovered, and repositioned.

Small Molecule 98

Small Molecule FDA Approval Disease Pharmaceutical Companies 98

The Pharma Data

MAY 6, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

FDA Approval 52

FDA Approval Licensing Licensing FDA 52

PerkinElmer

NOVEMBER 9, 2022

To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs). Recent efforts have focused on the development of small-molecule inhibitors as an alternative approach to therapeutically target PD-1 or PD-L1.

Small Molecule 52

Small Molecule Research Immune Response FDA Approval 52

The Pharma Data

JANUARY 25, 2021

–( BUSINESS WIRE )– Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. 26, 2021 13:00 UTC. FREDERICK, Md.–( About VLX-1005.

FDA 52

FDA Small Molecule FDA Approval Drugs 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

New Drug Approvals

APRIL 2, 2025

1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [11] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals. [2]

FDA 62

FDA Therapies Trials Treatment 62

Conversations in Drug Development Trends

MAY 30, 2024

From drugs previously FDA-approved for gallstone diseases, Parkinson’s disease, and even cancer, researchers are working tirelessly to test and establish whether these pharmacotherapies with well-defined safety profiles may have any potential for efficacy in treating ALS.

Treatment 81

Treatment Clinical Trials Small Molecule Therapies 81

Drug Target Review

MAY 1, 2024

To date, the 11 FDA-approved ADCs have shown benefit to patients across multiple solid and hematological malignancies with approvals in more than 20 indications. He has more than 14 years of experience in studying the design and synthesis of new payloads and drug-linkers for antibodies, small molecules, and nanoparticles.

Drugs 69

Drugs FDA Approval Organic Chemistry Small Molecule 69

The Pharma Data

NOVEMBER 15, 2020

Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).

Science 52

Science Small Molecule FDA Approval Therapies 52

The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

FDA Approval 52

FDA Approval Therapies Small Molecule FDA 52

The Pharma Data

MAY 7, 2021

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

OCTOBER 15, 2020

Manufacturing cells is not like manufacturing small molecules,” Brian Culley, CEO of Lineage Cell Therapeutics , told BioSpace. On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option.

Therapies 52

Therapies Small Molecule FDA FDA Approval 52

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S.,

FDA 40

FDA FDA Approval Small Molecule Drugs 40

New Drug Approvals

DECEMBER 16, 2023

Retrieved 10 December 2023. ^ “Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH” Novartis (Press release). twitter +919321316780 call whatsaapp EMAIL. 5 December 2023. Retrieved 6 September 2023.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

The Pharma Data

JANUARY 31, 2021

If FDA approved, CONV 01-? would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for the use of 225 Ac in cancer treatment. . Convergent has identified certain small molecules that bind to PSMA, but at a different epitope than does CONV 01-?,

Small Molecule 40

Small Molecule FDA Approval Therapies Trials 40

Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

FDA Approval 52

FDA Approval DNA Small Molecule FDA 52

The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 versus 38.9%). .”

Therapies 52

Therapies FDA Approval Treatment Small Molecule 52

Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Advarra

JANUARY 11, 2024

Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

NIH Director's Blog: Drug Discovery

MARCH 8, 2016

With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved.

DNA 52

DNA Drugs Small Molecule FDA Approval 52

Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Even newer from the pharma benches are 12 small molecule drugs highlighted by Chris de Savi [4], whose structures were first disclosed at the ACS and AACR meetings in Q1 2023. Of these 12 drugs, 9 contain at least one fluorine!

Drugs 52

Drugs Small Molecule FDA Approval Metabolic Stability 52

The Pharma Data

JANUARY 6, 2021

Bio-CDMO business offers services for biopharmaceuticals and small molecule pharmaceuticals. Going forward, Fujifilm will continue to contribute to the healthcare industry by providing a stable supply of high quality pharmaceuticals. * Overview of New Site. 1. Location.

Packaging 52

Packaging Small Molecule Production FDA Approval 52

The Pharma Data

FEBRUARY 25, 2022

CGRP Receptor Antagonism Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. There is a significant unmet need for new treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.

Treatment 52

Treatment Small Molecule FDA Approval Therapies 52

The Pharma Data

NOVEMBER 25, 2020

FDA has responded by working closely with stakeholders to facilitate the development of safe and effective therapeutics for COVID-19. FDA oversight of drugs does not end with approval; the FDA is empowered by statute to ensure the safety, efficacy, and high quality of approved and marketed drug products, including Veklury.

FDA 52

FDA Treatment Clinical Trials Hospitals 52

The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

DECEMBER 23, 2020

LYT-100 is an anti-fibrotic and anti-inflammatory oral small molecule that has been designed to overcome the tolerability challenges associated with pirfenidone, an anti-inflammatory, anti-fibrotic drug currently on the market. The trial is ongoing in the U.S. and Europe, and PureTech Head of Innovation, Dr. Michael C.

Clinical Trials 52

Clinical Trials FDA Small Molecule Trials 52

NIH Director's Blog: Drug Development

JULY 20, 2017

The first major advance in molecularly targeted drug treatment for the disease came in 2012, when the Food and Drug Administration (FDA) approved ivacaftor (Kalydeco). About 30,000 Americans have CF. As exciting as that was, we knew it represented just the first step on a challenging road to helping all people with CF.

Clinical Trials 52

Clinical Trials Small Molecule Therapies Disease 52