New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. All volunteers with AD had P. 2019 Jan;5(1):eaau3333.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Drug Target Review

JUNE 12, 2023

The current version of Chemistry42 uses over 40 generative models, including generative autoencoders and generative adversarial networks as well as both structure-based and ligand-based drug design to generate and optimise de novo small molecules.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Agency IQ

JUNE 9, 2023

However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs. The guidance contains recommendations for small molecule drugs, as well as any biological products that fall within CDER’s purview.

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FDA Small Molecule Science Immune Response 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Practical Cheminformatics

JANUARY 8, 2024

While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns. Data from 21 million molecules and more than 40,000 assays was securely combined into a multitask model. For classification models, the participants reported a median 2.5-7.5%

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Drugs Small Molecule Bioinformatics Packaging 141

The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. The secondary outcome involves pharmacokinetic endpoints. Oral, Small Molecules. The primary outcome includes safety and tolerability endpoints.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

NOVEMBER 11, 2020

Adding a new building, which will house up to 100 biologists by the end of the year, will bring together all the key functions for cutting-edge and high-performance small molecule discovery and up to commercial development.

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Small Molecule Science Pharmacokinetics Disease 40

The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. . . ?.

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Clinical Trials Clinical Development Small Molecule Trials 40

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This has spawned a movement focused on optimizing dose selection in oncology drug development.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

SEPTEMBER 15, 2020

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. BNT162 mRNA-based Vaccine Program. and -50.4% mg/dL reduction for placebo.

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Vaccine Therapies Trials Clinical Trials 52

The Premier Consulting Blog

APRIL 25, 2023

In the US, new small molecule drugs are developed under the requirements of Sections 505(b)(1) and 505(b)(2) of the FFDCA. 4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Guideline S10: Photosafety evaluation of pharmaceuticals.

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FDA Animal Testing Pharmacokinetics Small Molecule 52

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Concert Pharmaceuticals, Inc. Concert Pharmaceuticals, Inc. Concert Pharmaceuticals, Inc.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. Talking Medicine uses advanced AI to provide pharmaceutical companies with real-time data intelligence. All jobs have been maintained and the workforce has grown from about 220 to 350.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

The Pharma Data

AUGUST 21, 2020

It’s a coalition of globally renowned academic institutions, pharmaceutical companies and nonprofit research organizations. Novartis has agreed to contribute a carefully curated library of about 1300 small molecules with antiviral activity to the CARE project. CARE stands for Corona Accelerated R&D in Europe.

Virus 52

Virus Small Molecule Licensing Licensing 52

The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4. About Aptorum Group.

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Small Molecule Clinical Trials Trials Pharmacokinetics 52