New Drug Approvals

JULY 19, 2025

3] [4] A prodrug of contezolid, contezolid acefosamil, which is formulated for IV administration [5] is in Phase III clinical trials for diabetic foot infection. [6] 3] [4] A prodrug of contezolid, contezolid acefosamil, which is formulated for IV administration [5] is in Phase III clinical trials for diabetic foot infection. [6]

Clinical Trials

New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. 4] [5] [6] [7] [8] It is taken by mouth. [1] Shale, U.J. Reeves, E.P.

FDA

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials. Front Pharmacol.

Drug Research

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] 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 1] It is taken orally. [1] Kirsch I (2014).

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.

Packaging

New Drug Approvals

JULY 2, 2025

1] It was discovered by Chugai Pharmaceutical Co. 1] [3] Clinical trials The results of Phase I safety and Phase II ascending-dose clinical trials enrolling people with obesity or type 2 diabetes were published in 2023. [4] 1] It was discovered by Chugai Pharmaceutical Co. 1] It was discovered by Chugai Pharmaceutical Co.

Small Molecule

DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

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 drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

Treatment

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. The pharmacokinetic and pharmacodynamic properties of each drug and the patient’s individual variability contribute to the potential for interactions.

Clinical Development

New Drug Approvals

APRIL 18, 2025

potassium hydroxide), and water to prepare 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine (Compound 1) or a pharmaceutically acceptable salt thereof is provided below in Scheme VII. Br), in the presence of an alkylating-step solvent (e.g.,

FDA

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. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

FDA

The Premier Consulting Blog

DECEMBER 16, 2024

Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty decisions about whether to slow down or hit the brakes on a development program. Clear evidence of failure, such as negative clinical trial results where a drug fails to meet primary endpoints, necessitates abandoning the program.

Clinical Trials

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. This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations.

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] 2021, 39, 3002−3011. 228) Keam, S.

Metabolic Stability

The Pharma Data

JUNE 18, 2025

Biogen Launches Global Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia Biogen has officially launched its BRAVE study a pivotal, global Phase 3 clinical trial aimed at evaluating omaveloxolone in pediatric patients with Friedreich ataxia (FA). Head of the Neuromuscular Development Unit at Biogen.

Trials

New Drug Approvals

JULY 18, 2025

9] Azvudine is under investigation in clinical trial NCT04668235 (Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (Sars-cov-2 Infected)). 14] Curiously, no full results of the trial have been made available for this study in any journal detailing the experiment design as of December 2022. [23]

RNA

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 Safety, pharmacokinetics and pharmacodynamics of hetrombopag olamine, a novel TPO-R agonist, in healthy individuals. was coupledwith furoic acid (6.2)

Small Molecule

New Drug Approvals

JULY 28, 2025

2] Dorzagliatin is under investigation in clinical trial NCT03173391 (Long-term Efficacy and Safety of HMS5552 in T2DM). Safety, tolerability, pharmacokinetics, and pharmacodynamics of novel glucokinase activator HMS5552: results from a first-in-human single ascending dose study. Dorzagliatin: First approval. Drugs 2022, 82, 1745−1750.

Small Molecule

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

Drug Development

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

Pharmaceutical Companies

Drug Target Review

OCTOBER 24, 2023

Microbiotica’s approach differs from traditional pharmaceutical development, offering unique advantages in the field of precision medicine. In addition to analysing metagenomics data, we also isolated bacteria from the healthy donor stool banked as part of that trial.

Treatment

The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. We are delighted with our progress and anticipate that data from this trial will yield important insights that will be applied to our planned Phase 2b clinical trial, which is scheduled to begin in 2021.” ” About Hepion Pharmaceuticals.

Clinical Trials

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

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., 5, 2020 11:00 UTC.

Pharmaceuticals

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions. Tags Clinical Trials Weight 1

Clinical Trials

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. The International Consortium for Innovation and Quality in Pharmaceutical Development has published guidelines to qualify as a valid model for specific organ-chip applications. The US FDA Modernisation Act 2.0.,

Animal Testing

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.

Trials

New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. 1] It is a transthyretin-directed antisense oligonucleotide. [1] 7 March 2023.

Clinical Trials

The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About ALS-4. About Aptorum Group.

Small Molecule

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Watch it now.

Science

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec. Galactosidase-A enzyme.

Clinical Trials

The Pharma Data

JANUARY 17, 2021

Spero has previously reported data from a Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for targeting MDR Gram-negative bacterial infections. SHANGHAI , Jan.

Clinical Trials

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories

The Pharma Data

NOVEMBER 22, 2020

. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” About Molecular Partners’ anti-COVID-19 program.

Trials

Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

Clinical Trials