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

Drug Target Review

APRIL 7, 2025

The challenge of GPCR drug discovery G protein-coupled receptors (GPCRs) are one of the most desirable and challenging target classes in drug discovery, as their mutation can lead to a wide range of diseases such as cancer, cardiovascular disorders and neurological conditions.

Fragment Screening

The Pharma Data

AUGUST 1, 2025

Food and Drug Administration (FDA). The collaboration between Autolus and AGC Biologics began in 2020, with AGC’s Milan facility entrusted with the development, manufacturing, and commercial supply of lentiviral vectors, a critical component in the production of Autolus’ obe-cel CAR-T product.

Therapies

New Drug Approvals

JULY 25, 2025

The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. In individuals diagnosed with DMD, the primary mechanism through which corticosteroid drugs exhibit their effectiveness is by exerting anti-inflammatory effects. Shale, U.J.

FDA

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.

Small Molecule

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Food and Drug Administration (FDA).

FDA

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

New Drug Approvals

MAY 9, 2025

1] History The efficacy of elacestrant was evaluated in the EMERALD trial, which was a randomized, open-label, active-controlled, multicenter study involving 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer. Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1]

FDA

LifeSciVC

JULY 8, 2025

The core claim was structural: the future of biotech depends as much on what supports the drug as what is in it. Introduction At this year’s Guggenheim biotech investor conference in Boston, the keynote wasn’t about drug pipelines, IPO windows, or FDA guidance. It was about special operations warfare. Today, discovery itself is global.

Hospitals

New Drug Approvals

JUNE 15, 2025

Retrieved 15 September 2024. ^ “Notice: Multiple additions to the Prescription Drug List (PDL) [2024-08-13]” Health Canada. Retrieved 15 August 2024. ^ “Regulatory Decision Summary for Zilbrysq” Drug and Health Products Portal. Food and Drug Administration (FDA). Food and Drug Administration (FDA).

FDA

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. Subscribe to Asimov Press.

Vaccine

New Drug Approvals

JUNE 29, 2025

2020/0062765) was dissolved in ethanol (604 mL) at 50℃. 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] Food and Drug Administration. Food and Drug Administration (FDA). Application Publication No.

International

LifeSciVC

JUNE 12, 2025

Building medicines by activating biological pathways As I joined the Company in Q4 2020 as its CEO, I had a vision of creating protein variants to activate biological pathways. This meant focusing on clinical benefit for patients with AATD and build a drug candidate profile that was meaningful for patients.

RNA

Codon

JUNE 5, 2025

Dozens more clinical trials, based upon similar gene-editing technologies, are now underway. Cas9 is also being used in a number of ongoing clinical trials for everything from HIV to protein folding disease and lymphoma. Therapeutics The first Cas13-based clinical trial was approved in 2024.

DNA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

SciePro via Getty Images Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic non-small cell lung cancer has a type of alteration in the gene ROS1. though the drug’s commercial prospects are unclear.

FDA

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

New Drug Approvals

JULY 8, 2025

1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety.

Virus

New Drug Approvals

APRIL 19, 2025

4] Landiolol can be used as first-line treatment for acute ventricular rate control in patients with atrial fibrillation (Level I recommendation- 2020 Guidelines of the European Society of Cardiology [15] ). Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. IV -Blocker max. 20 November 2023.

FDA

Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA

BioPharma Drive: Drug Pricing

JULY 18, 2025

Food and Drug Administration headquarters in Silver Spring, Md., Alamy The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. You can unsubscribe at anytime.

Therapies

BioPharma Drive: Drug Pricing

JULY 14, 2025

XH4D via Getty Images A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drug development and manufacturing organization’s business is poised to grow in the years ahead. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

Production

Codon

AUGUST 4, 2025

Today, it is used in everything from chemical analysis to drug discovery, but it was not initially developed with biologists in mind. The organization traces its origins back to 2020, when Adam Marblestone , CEO of Convergent Research, first approached Nikolai Slavov. Closeup of samples being loaded into the mass spectrometer.

Laboratories

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. Deuterium in drug discovery: progress, opportunities and challenges. Nature Reviews Drug Discovery, DOI: 10.1038/s41573-023-00703-8, published online 5 June 2023 ACS Omega 2021, 6, 5532−5547. Drugs 2021, 81, 1915−1920.

Metabolic Stability

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?

Drugs

Drug Patent Watch

JANUARY 8, 2025

This comprehensive guide will walk you through the intricacies of optimizing your drug patent strategy, ensuring that your innovations are safeguarded and your market position is strengthened. Understanding the Basics of Drug Patents Before diving into the nuances of patent strategy, it’s crucial to grasp the fundamentals.

Pharmaceutical Companies

National Institute on Drug Abuse: Nora's Blog

JUNE 12, 2025

1 The drug crisis in America has demanded a sustained focus to extinguish those fires by expanding treatment access and overdose prevention and reversal strategies—and encouragingly, data show that overdose fatalities have been declining since 2023. The White House, Executive Office of the President, Office of National Drug Control Policy.

Research

New Drug Approvals

JULY 28, 2025

Chiglitazar (trade name Bilessglu ) is a drug for the treatment of type 2 diabetes. [1] 2] Chiglitazar is under investigation in clinical trial NCT06125587 (Chiglitazar/ metformin in Non-obese Women With PCOS). Drugs 2022, 82, 87− 92. Patent US 10640465 B2, 2020. “Chiglitazar: First Approval” Drugs.

Trials

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] 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)). -D-ARABINOFURANOSYL)-

RNA

BioPharma Drive: Drug Pricing

JULY 24, 2024

Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

Trials

New Drug Approvals

JULY 28, 2025

1] Unlike other diabetes drugs, it is intended to increase insulin sensitivity. [2] 2] Dorzagliatin is under investigation in clinical trial NCT03173391 (Long-term Efficacy and Safety of HMS5552 in T2DM). Drugs 2022, 82, 1745−1750. Drugs 2020, 80, 467−475. Dorzagliatin: First approval. 134) Xu, H.; 135) Ren, Y.;

Small Molecule

PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs.

Clinical Trials

Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule

Drug Hunter

AUGUST 21, 2023

Obtaining adequate drug exposure in the brain is key to treating CNS diseases effectively. Recently, Dennis Koester gave us a crash course in CNS drug discovery in a Drug Hunter Flash Talk. Why Kp,uu is the Most Important Parameter in CNS Drug Discovery What Influences the Kp,uu of Drugs?

Drugs

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

Treatment

The Pharma Data

MAY 3, 2021

In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year. . 2020 was a challenging year.

Science

Drug Target Review

SEPTEMBER 21, 2023

The findings supported the possibility put forward by Cotton et al (2016) concerning the chance of repurposing these drugs for adulticidal treatment. Need for adulticidal drugs More than 99 percent of countries worldwide has been affected by this disease. They provided a big stepping stone, needed for the development of drugs.

Drugs