Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 8 This is not the only point of interest. We hope it was a useful two-parter!

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The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Our ambition is to develop life-changing treatments for patients.

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DrugBank

JULY 24, 2024

These multifunctional small molecules are like tiny spies, hijacking the body’s natural protein degradation system to remove unwanted proteins. Similarly, PROTACs can target and degrade overexpressed proteins, offering a way to overcome drug resistance, a common issue in cancer treatment.

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The Pharma Data

JULY 29, 2021

Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses.

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Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). How does the DCI mechanism compare to the design of other drugs for cancer treatment?

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ASPET

SEPTEMBER 16, 2024

We further demonstrate that daily oral treatment with a novel mitofusin activator derived from the natural product piperine can reverse these neurological phenotypes. Here, we describe motor and sensory neuron dysfunction characteristic of clinical CMT type 2A in a CRISPR/Casp-engineered Mfn2 Thr105Met (T105M) mutant knock-in mouse.

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Drug Target Review

JULY 23, 2024

This laid the groundwork for my career in drug discovery using novel modalities like small molecule inhibitors, antibodies, RNA interference (RNAi) and, currently, small molecule protein degraders – which are opportunities to change how we think about medicines.

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The Pharma Data

JULY 12, 2021

Orelabrutinib is a Phase 2 oral small molecule Bruton’s tyrosine kinase inhibitor with high selectivity and the ability to cross the blood-brain barrier InnoCare to receive a $125 million upfront payment and is eligible to receive potential development and commercial milestone payments. Biogen Inc.

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The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration. TOKYO and CAMBRIDGE, England , Dec. Vlad Coric , M.D.,

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The Pharma Data

NOVEMBER 19, 2020

Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. References.

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The Pharma Data

JANUARY 19, 2021

This milestone supports the transition of Aptorum Group to a clinical-stage company and reflects the potential of our scientific rigor and novel approach of our products. We are dedicated to delivering novel therapeutics in the field of growing unmet medical needs of infections starting with Staphylococcus aureus.”. About ALS-4.

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The Pharma Data

DECEMBER 20, 2020

ALS-4 is a novel small molecule adopting an anti-virulence (non-antibiotic) approach to address the growing unmet medical needs of infections caused by Staphylococcus aureus. Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. About ALS-4.

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LifeSciVC

AUGUST 5, 2024

We are constantly reminded how we are in the midst of an artificial intelligence revolution of the drug development process which promises to completely transform how we develop drugs with increases in productivity of an order of magnitude or more. a company with the strongest pipeline in the entire industry.”

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The Premier Consulting Blog

NOVEMBER 20, 2024

It ensures that a production process consistently yields products of predetermined quality and safety. In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.

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Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production.

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ProRelix Research

NOVEMBER 23, 2022

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […].

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FDA Law Blog: Biosimilars

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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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. Strovel, PhD, Chief Executive Officer of Veralox Therapeutics. About VLX-1005.

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Drug Target Review

JUNE 19, 2024

Our goal is to stand on the shoulders of giants and advance this exciting and new field of medicine, so that it can deliver valuable treatments to patients. We look at that long list and ask which of the cell types looks attractive to us as a potential product. Could you give us an overview of the Lineage platform?

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Drug Target Review

JANUARY 4, 2024

First, getting from the starting material to the end therapeutic product is often long and slow, as well as tricky to do consistently and repeatedly. This is in part due to a complex manufacturing process, which is harder to control than those used for other modalities (such as small molecules and monoclonal antibodies).

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. (Chipscreen Biosciences, Stock Symbol: 688321.SH

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The Pharma Data

NOVEMBER 25, 2020

The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different. Source: FDA.

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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 2] Medical uses Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults. [1] The FDA has long supported development of non-opioid pain treatment. Suzetrigine is taken by mouth. [1]

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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The Pharma Data

JANUARY 13, 2021

These Phase 2 results strongly support the continued development of dexpramipexole as a potential first-in-class oral agent for the treatment of eosinophilic asthma,” said Michael Bozik, M.D., Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma.

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Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

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The Pharma Data

NOVEMBER 29, 2020

(Headquarters: Cambridge, UK, “Wren”) today announced that the companies have entered into an exclusive research collaboration agreement aiming to advance the discovery of novel small molecules that target ?-synuclein synuclein for the potential treatment of synucleinopathies including Parkinson’s disease and dementia with Lewy bodies.

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KIF1A

JULY 1, 2023

Read the Pre-print Rare Roundup A seemingly small semantic issue is a major roadblock to develop treatments for rare diseases We’ve spoken often about the goal of repurposing existing drugs to better treat KAND – this is a reality for many families who utilize off-label prescriptions. * What’s a pre-print?

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New Drug Approvals

OCTOBER 12, 2024

ALZ-801 is a potent and orally available small-molecule β-amyloid (Aβ) anti-oligomer and aggregation inhibitor, valine-conjugated proagent of Tramiprosate with substantially improved PK properties and gastrointestinal tolerability compared with the parent compound. The product slowly crystallized. 2018; 32(9): 849–861. [2].

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Fierce BioTech

AUGUST 25, 2023

Biopharma companies focused on meeting their objectives and fostering innovation in creating effective treatments have turned to outsourcing their analytical method development and testing to CDMOs. Today there are many CDMOs who offer services in various domain of analytical testing. Listing Image Alcami-Logo-Listing-10032023.png

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Nvidia Developer: Drug Discovery

DECEMBER 19, 2023

This data advantage enables their AI and product teams to outperform SoTA annotation and design models, addressing complex design challenges in biotech industries, from gene-writing therapeutics to plastic degradation. For more information, see the NVIDIA BioNeMo product page.

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Sygnature Discovery

SEPTEMBER 25, 2023

Simon Hirst , CEO of Sygnature Discovery says: “The physical properties of targeted protein degradation and bifunctional molecules are unusual compared to classical small molecule development, as they’re outside the rule of five.

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The Pharma Data

APRIL 6, 2021

Data related to Bayer’s precision oncology treatment, larotrectinib (Vitrakvi ), the first ever treatment to receive a tumor-agnostic indication at the initial time of U.S. This includes preclinical data on darolutamide analyzing the impact of androgen stimulation and darolutamide treatment. EU, UK and Japan.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. NEW YORK , Jan. 27, 2021 /PRNewswire/ — Q Biomed Inc.

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The Pharma Data

MAY 31, 2022

The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali.

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