Alta Sciences

JULY 3, 2025

Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drug development world, staying agile is essential to enabling more informed decisions, faster. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve.

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The Pharma Data

JUNE 12, 2025

The presentations highlight the ongoing progress and growing promise of the company’s innovative therapeutic platform, featuring its investigational oral CELMoD™ (Cereblon E3 Ligase Modulating Drugs) agents mezigdomide, iberdomide, and golcadomide, alongside its first-in-class, oral BCL6 (B-Cell lymphoma 6) ligand-directed degrader (LDD) BMS-986458.

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Drug Target Review

JUNE 16, 2025

G protein-coupled receptors (GPCRs) are a highly validated drug target family – accounting for 30-35 percent of all approved drugs. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

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Drug Target Review

JULY 3, 2025

Given macro healthcare influences (eg, economic uncertainty, environmental changes) and the numerous available treatments for major diseases, drug developers may need to reassess their therapeutic strategies. This has led drug developers to unintentionally limit their potential within chosen therapeutic spaces.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.

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Fierce BioTech

MAY 27, 2025

jgrcic Tue, 05/27/2025 - 11:55 Tue, 05/27/2025 - 11:55 Resource Type Whitepaper Promotion Start Tue, 05/27/2025 - 12:06 Use of healthy volunteers in first-in-human trials with oncology small molecules. Can an alternative approach expedite clinical development of small molecule oncology drugs and benefit patients?

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New Drug Approvals

JULY 2, 2025

Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1]

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The Pharma Data

JUNE 25, 2025

The drug’s mechanism also aims to delay the overall progression of disease severity—an urgent need in a patient population that often progresses to end-stage renal disease. In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. Eastern Time on June 25, 2025.

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Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Toxicological investigations play a key role in assessing drug safety and, importantly, inform development decisions.

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New Drug Approvals

JULY 6, 2025

It is a small molecule delivered orally. [1] “Prospect of acromegaly therapy: molecular mechanism of clinical drugs octreotide and paltusotine” Nature Communications. amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00 amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00 mmol) and DIPEA (1.19

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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 1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 Journavx is the first drug to be approved in this new class of pain management medicines.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. The revisions due in 2025 include testing for NDSRIs.

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New Drug Approvals

JULY 10, 2025

g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]

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LifeSciVC

JANUARY 16, 2024

Small molecule GLP1s? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Whether it’s small molecules to target the incretins (GLP1R ± GIPR), targeting well-validated signaling nodes in I&I (e.g.,

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Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. billion by 2025, growing at a CAGR of 34.2% from 2020 to 2025[1]. . billion by 2025, growing at a CAGR of 34.2% from 2020 to 2025[1].

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Biosimilars Marketing Treatment Small Molecule 59

New Drug Approvals

MAY 26, 2025

S2CID 253257260. ^ “With the right partner, Pfizer gains fast-track tag for previously shelved NASH drug” Retrieved 20 November 2023. Ervogastat CAS 2186700-33-2 Non-alcoholic Steatohepatitis (NASH) with Liver Fibrosis (FAST TRACK – U.S.) 1] Its development was previously halted by the company but resumed in 2022. [2]

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Molecular Design

DECEMBER 31, 2024

My pulse will be quickenin' With each drop of strychnine We feed to a pigeon It just takes a smidgin To poison a pigeon in the park Tom Lehrer, Poisoning Pigeons in the Park | video ** Ill be reviewing the H2024 study (Occurrence of Natural Selection in Successful Small Molecule Drug Discovery) in this post.

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New Drug Approvals

JUNE 26, 2025

Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. Food and Drug Administration (FDA).

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Alta Sciences

FEBRUARY 10, 2025

Let Us Guide You Through the Process blussier Mon, 02/10/2025 - 17:54 HTML Let Us Guide You Through the Process Altasciences' experts streamline the IND/CTA application process by designing your regulatory strategy and thoroughly planning and completing your required preclinical studies.

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Fierce BioTech

JANUARY 3, 2025

Optimizing Formulation Strategies for Poorly Soluble Compounds: Insights into Bioavailability Enhancement and Accelerated Development dwunderlin Fri, 01/03/2025 - 15:54 Wed, 02/19/2025 - 11:00 Resource Type Webinar Feng Zhang, Ph.D. On Demand Start Date Wed, 02/19/2025 - 12:00 Hong Li, Ph.D.

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The Pharma Data

JUNE 9, 2025

Pimicotinib: A Promising CSF-1R Inhibitor Pimicotinib is an investigational small molecule developed by Abbisko Therapeutics Co., In parallel, we are working to file a New Drug Application (NDA) to the U.S. Food and Drug Administration, with additional filings planned in other markets.”

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New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Retrieved 25 January 2025. Food and Drug Administration (FDA).

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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New Drug Approvals

APRIL 30, 2025

1] [2] [3] Levacetylleucine is the second medication approved by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease type C. [2] 2] The US Food and Drug Administration (FDA) granted the application for levacetylleucine priority review , fast track , orphan drug , and rare pediatric disease designations. [2]

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The Pharma Data

JANUARY 19, 2021

On January 19, its investigational new drug (IND) for GC019F, a FasTCAR-enabled CAR-T therapy in relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL) was approved by China’s National Medical Products Administration (NMPA). Its first drug is PHVS416 for HAE, with plans to initiate a Phase II trial this year.

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BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Unlike most approved drugs, which work by turning cell signaling up or down like a dimmer switch, this approach aims to rid cells of problem proteins entirely.

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The Pharma Data

JANUARY 4, 2021

SENS-401 has demonstrated highly encouraging efficacy in preclinical models and we are excited to progress this small molecule towards clinical trials to address this significant unmet medical need in cancer patients undergoing cisplatin treatment. Petremann M, Tran Van Ba C, Broussy A, Romanet C, Dyhrfjeld-Johnsen J.Otol Neurotol.

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Drug Target Review

MAY 31, 2024

My career choice was made from an early age when I was deeply affected by both my Uncle’s HIV+ diagnosis and then the extraordinary cocktails of antiretroviral drugs he took, which gave me another 20 years with him beyond his doctor’s initial grim projection. They are only going to do that when they feel valued and heard.

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The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

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New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 10] However, a more recent study assessing neuroendocrine effects of the drug in normal volunteers and subjects with a history of cocaine dependence reported observations consistent with modest MOR antagonism at the 10 mg dose. [11]

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The Pharma Data

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . 5% have US Food and Drug Administration -approved treatments. The combined company is expected to deliver double-digit average annual revenue growth through 2025.

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The Pharma Data

FEBRUARY 4, 2021

As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion , above previous guidance of greater than $10 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.

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Agency IQ

AUGUST 11, 2023

FDA lays out new assessment framework for certain nitrosamines Late last week, the FDA addressed developing knowledge – and concern – about nitrosamine drug substance related impurities (NDSRIs) in a final, immediately-in-effect guidance for industry. To ensure the safety of the U.S.

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Agency IQ

JULY 26, 2024

In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.” Any CMC changes (e.g.,

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Alta Sciences

APRIL 24, 2025

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data. This blog was originally published in April 2025.

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The Pharma Data

JUNE 11, 2025

The partnership will now place increased emphasis on integrating genomic data with disease biology, refining drug target identification, and accelerating the path from gene discovery to therapeutic development—particularly in complex, genetically mediated diseases like dilated cardiomyopathy (DCM). Source link

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The Pharma Data

MARCH 28, 2022

By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. These drug discovery platforms, for example, synthetic biology, TAILORED COVALENCY™ chemistry, and multispecific NANOBODY ® molecules, are allowing Sanofi to pursue both injectable and oral therapeutics.

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