Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Conventional models often fail to predict cardiac side effects, especially with biologics.

Drug Research

The Pharma Data

JUNE 25, 2025

Phase 1 Study Overview The Phase 1 clinical program was structured as a single ascending dose study to assess safety, tolerability, and pharmacokinetics of salanersen. Biogen emphasized that no dose-limiting toxicities were observed, and there were no reports of serious adverse events directly attributable to the study drug.

Therapies

New Drug Approvals

JULY 19, 2025

CZA rapidly converts into the active drug CZD in vivo. In a pharmacokinetic (PK) rat model, the exposure of active drug CZD after IV administration of the prodrug CZA was similar to or higher than that from the IV administration of CZD. Drugs 2021, 81, 1587− 1591. (34) 34) MicuRx Pharmaceuticals. to furnish 4.3

Clinical Trials

The Pharma Data

JUNE 23, 2025

In tandem with the Phase 2 results, Amgen also shared detailed data from its Phase 1 Pharmacokinetics Low Dose Initiation (PK-LDI) study. Crucially, weight loss in the MariTide-treated groups had not plateaued at the 52-week mark , indicating the drug’s potential to drive continued weight reduction beyond one year.

Trials

New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. Drugs 2024, 84, 111− 117. (71) 70) Keam, S. 71) Hoffman, E.

FDA

The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes. Alignment with U.S. Earlier this month, the U.S.

Packaging

Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable.

RNA

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] Food and Drug Administration.

FDA

Drug Patent Watch

DECEMBER 11, 2024

Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). ” – Dr.

Drug Development

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. “The classic paradigm with todays psychiatry drugs involves patients chronically taking a daily medication,” says Donello.

Treatment

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] 1] It was discovered by Chugai Pharmaceutical Co. 1] It was discovered by Chugai Pharmaceutical Co. Orforglipron’ CAS 2212020-52-3 C 48 H 48 F 2 N 10 O 5 883.0

Small Molecule

DrugBank

JULY 14, 2025

Drug-drug interactions (DDI) are a significant concern in clinical trials, where the safe and effective administration of drugs to patients is crucial. These interactions can alter the pharmacological activity of one or more drugs, potentially leading to diminished therapeutic effects or unexpected toxic reactions.

Clinical Development

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] . : 321839-75-2 Molecular Weight 519.50 1] It is taken by mouth. [1]

FDA

The Pharma Data

JULY 3, 2025

These services play a crucial role in the development of next-generation conjugate vaccines, antibody-drug conjugates (ADCs), activated polyethylene glycols (PEGs), and polymer-based drug delivery systems—therapeutic modalities that are rapidly gaining prominence in the pharmaceutical and biotechnology sectors. source link

Science

The Premier Consulting Blog

DECEMBER 16, 2024

New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3

Clinical Trials

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Retrieved 12 October 2024. ^ “Details for: Sibboran” Health Canada.

FDA

PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes.

Clinical Trials

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] Drugs 2021, 81, 1915−1920.

Metabolic Stability

Drug Patent Watch

JANUARY 14, 2025

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?

Drug Development

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

RNA

New Drug Approvals

JULY 28, 2025

1] Unlike other diabetes drugs, it is intended to increase insulin sensitivity. [2] Drugs 2022, 82, 1745−1750. Safety, tolerability, pharmacokinetics, and pharmacodynamics of novel glucokinase activator HMS5552: results from a first-in-human single ascending dose study. Drugs 2020, 80, 467−475. 134) Xu, H.; 135) Ren, Y.;

Small Molecule

New Drug Approvals

JULY 21, 2025

49 Akilo-scale, chromatography-freesynthesisofhetrombopag has been reported by researchers at Jiangsu Hengrui Pharmaceutical in the Chinese-language patent literature (Scheme 12).50,51 Drugs 2021, 81, 1581−1585. (47) Safety, pharmacokinetics and pharmacodynamics of hetrombopag olamine, a novel TPO-R agonist, in healthy individuals.

Small Molecule

DrugBank

SEPTEMBER 19, 2024

Oral drug delivery remains the gold standard in pharmaceutical administration. Compared to other routes, like injectables, oral drugs are cost-effective to manufacture and administer. However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges.

Drugs

DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle.

Drug Development

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market.

Pharmaceutical Companies

Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Most of the LLM activity in the drug discovery space in 2023 was reported as preprints from academic groups. Most of the drug discovery examples were underwhelming. Here’s the structure of Part II.

Drugs

Drug Target Review

OCTOBER 24, 2023

Microbiotica’s approach differs from traditional pharmaceutical development, offering unique advantages in the field of precision medicine. We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD.

Treatment

Drug Hunter

MAY 18, 2023

Dian Su’s journey from chemistry and proteomics to the DMPK of drug conjugates Following a different path comes naturally to Dian Su, Senior Director of DMPK at Bicycle Therapeutics. Dian eventually made her way to Shanghai, where she encountered a much bigger world while earning degrees in pharmaceutical engineering and medicinal chemistry.

Small Molecule

The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

Disease

Drug Target Review

NOVEMBER 15, 2023

Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.

Pharmacokinetics

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

Animal Testing

DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.

Cell Based Assays

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. When imaged, the hiPSC showed a stable beating rate.

Drugs

Drug Target Review

JUNE 12, 2023

TEAD proteins are crucial for tumour progression and drug resistance, making them an attractive focus for therapeutic interventions. Leveraging AI-guided structure-based drug design, Insilico’s research and development team generated an impressive portfolio of over 6,000 molecules and identified three highly promising hit series.

Metabolic Stability

Sygnature Discovery

JANUARY 26, 2024

Here at Sygnature Discovery, we offer specialised expertise in early-stage drug formulation. These strategies are tailored to the unique characteristics of each individual Active Pharmaceutical Ingredient (API). These strategies are tailored to the unique characteristics of each individual Active Pharmaceutical Ingredient (API).

Process Chemistry

New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology.

Clinical Trials