Sygnature Discovery

NOVEMBER 29, 2023

This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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Drug Discovery World

SEPTEMBER 26, 2022

To do this, the Drug Repurposing Hub has developed an open-access library of over 6,000 compounds, which are being tested against disease models in an effort to find new treatments using small molecules – many of which have already been approved by the FDA. . Diving into data . Volume 23 – Issue 4, Fall 2022. References .

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The Premier Consulting Blog

JANUARY 31, 2023

Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). Pharmacokinetic and systemic exposure data is also important to consider. On November 1, 2022, the U.S.

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Sygnature Discovery

NOVEMBER 29, 2023

This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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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. We hope it was a useful two-parter! We’re looking forward to the next crop!

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Drug Discovery World

JULY 8, 2024

By silencing transthyretin (TTR) mRNA, patisiran decreases the production of TTR protein, the molecule responsible for causing the disease. Since then, the FDA has approved five other siRNA drugs – givosiran, lumasiran, inclisiran, nedosiran and vutisiran – for various other diseases.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

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The Pharma Data

AUGUST 29, 2020

FDA and EMA have granted orphan drug designations to LNP023 for PNH and the rare renal disease complement 3 glomerulopathy (C3G). The FDA and EMA have granted orphan drug designations to LNP023 for the treatment of PNH and C3G. Small-molecule factor B inhibitor for the treatment of complement-mediated diseases.

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The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 for moderate to severe alopecia areata, which received U.S. Canada and Europe.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Author: Jayesh Patel , Principal Scientist, Pharmacokinetics

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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. Human factors. The new formulation resulted in a drug product that was very viscous.

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The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? and whether a molecule’s pharmacology can help to mitigate safety risk. Finally, as part of a broader pathway analysis, consider potential implications for selectivity.

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Drug Target Review

OCTOBER 4, 2023

Groundbreaking strategies like proteolysis-targeting chimeric molecules (PROTACs) are also being explored. 6 Combining the effect of payloads with different mechanisms of action – an approach that revolutionised small molecule chemotherapy – also holds the promise of enhanced therapeutic activity for ADCs.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Drug Discovery World

APRIL 12, 2023

Testing new modality drugs poses additional challenges The drug development pipeline is no longer predominantly composed of small molecule drugs. In a study by Long et al., This effect had not previously been observed as traditional hepatic cultures only remain stable for two weeks.

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Drug Discovery World

DECEMBER 13, 2023

Custom antibodies can be developed for pharmacokinetic assays and biodistribution assays, supporting therapeutic development by giving researchers data about the behaviour of their novel therapeutic in vivo. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

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Drug Discovery World

JANUARY 20, 2023

Testing new modality drugs poses additional challenges The drug development pipeline is no longer predominantly composed of small molecule drugs. In a study by Long et al., This effect had not previously been observed as traditional hepatic cultures only remain stable for two weeks.

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The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 is a novel, orally available, small molecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry.

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Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. Since its inception, OCE has initiated an extensive list of initiatives and has taken the lead on over forty guidances published by FDA.

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Alta Sciences

APRIL 17, 2024

Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression. Since the FDA approved the first oligonucleotide drug for clinical use in 1998, to treat cytomegalovirus retinitis (CMV) in immunocompromised patients, the therapeutic landscape has undergone significant change. Asia, and Europe.

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The Pharma Data

JANUARY 19, 2021

This small molecule therapy is presently in Phase 1 clinical trial for mild to moderate Alzheimer’s disease (AD), which is supported by a NIA R01 grant in healthy aged volunteers. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , About Neuronascent, Inc.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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The Pharma Data

DECEMBER 15, 2020

In late October, SetPoint Medical received Breakthrough Device Designation from the FDA for the use of its novel bioelectronic device by patients with rheumatoid arthritis (RA) who have incomplete response to, or are intolerant to multiple biologic drugs. Small Molecule Inhibitors. The FDA has set an action date of July 7, 2021.

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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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Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

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The Pharma Data

JANUARY 10, 2021

. TransCon hGH (lonapegsomatropin) : Lonapegsomatropin is an investigational long-acting prodrug of somatropin (human growth hormone or hGH) currently under review for use in pediatric growth hormone deficiency (GHD) by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA): .

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The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models.

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The Pharma Data

SEPTEMBER 15, 2020

Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allows for the enrollment of new populations. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1.

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The Pharma Data

OCTOBER 14, 2020

Inventiva is expected to hold the end of NATIVE Phase IIb clinical trial meeting with the FDA and to receive regulatory feedback from the EMA during the fourth quarter of 2020 with the initiation of the Phase III clinical trial evaluating lanifibranor in NASH planned for the first half of 2021. -- HubSpot Call - to - Action Code Browse Jobs No.

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