LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Small molecule GLP1s?

Small Molecule

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.

Clinical Pharmacology

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development

The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.)

Small Molecule

The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. About LX9211. Safe Harbor Statement.

FDA

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Xofigo is currently under further evaluation in a broad clinical development program in prostate cancer and beyond.

Small Molecule

Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. Jamie Rich, PhD is Senior Director of Technology, ADC Therapeutic Development at Zymeworks Inc.

Drugs

The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

Small Molecule

The Pharma Data

JANUARY 10, 2021

(Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S.

FDA

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We

Clinical Trials

The Pharma Data

OCTOBER 14, 2020

About VBL’s VB-600 Platform VBL is conducting two parallel drug development programs that are exploring the potential of MOSPD2 (motile sperm domain-containing protein 2), a protein that VBL has identified as a key regulator of cell motility, as a therapeutic target for inflammatory diseases and cancer.

Treatment

The Pharma Data

OCTOBER 18, 2020

CG-806 is an oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of lymphoid and myeloid hematologic malignancies. This press release contains forward-looking statements within the meaning of Canadian and U.S.

Clinical Trials

The Pharma Data

AUGUST 29, 2020

“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We Blood 2019;134(Suppl 1):3517. 3. Schubart A, et al. 4. Merle NS, et al.

Treatment

Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development.

FDA

The Pharma Data

MARCH 28, 2022

These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells. Two complementary candidates for COPD , developed in collaboration with Regeneron, targeting distinct subpopulations.

Small Molecule

Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

Drug Development

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drug development process as well.

FDA

The Pharma Data

DECEMBER 27, 2020

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials. Tislelizumab is not approved for use outside of China. About BRUKINSA ® (zanubrutinib).

Production

The Pharma Data

JANUARY 11, 2021

commented, “We believe that this investment will meaningfully accelerate MediciNova’s drug development in the pipeline and could lead to unleashing its highest potential in value. ” Motoki Sato, MD, Managing Director of 3D Investment Partners Pte. About MediciNova. MediciNova, Inc.

Clinical Trials

Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

Treatment

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Antibody-drug conjugates: Principles and opportunities. Phuna ZX, Kumar PA, Haroun E, Dutta D, Lim SH. 2024;347:122676. BMC Cancer. 2024;24(1):898.

Therapies

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Dive Brief: Shares of San Diego biotechnology company Cidara Therapeutics doubled Monday after the company revealed positive mid-stage study results for an experimental preventive therapy it’s developing for seasonal influenza.

Drugs

The Pharma Data

OCTOBER 26, 2020

Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. (formerly known as Seattle Genetics, Inc.) Canada and Europe. Organon & Co.

Vaccine

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science

Drug Target Review

APRIL 11, 2025

Drug development is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. By integrating diverse data modalities, including clinical genomics , it can impact target identification, patient stratification and clinical trial design. Lifescienceleader.com.

Clinical Development

Drug Target Review

APRIL 25, 2025

2 Liver CIVMs offer several benefits over conventional in vitro systems including prolonged functional activity, enhanced expression of various drug-metabolising enzymes and transporters, and improved cell-cell and cell-ECM (extracellular matrix) interactions. Communications Medicine 2022 2:1 2 (2022) 116.

Clinical Development

PPD

APRIL 25, 2025

New drug development usually comes with shareholder expectation for return on investment, which then continues to fund future innovation. This is also the case with the small molecule/pill penalty risk category, as Profile #3 is the only biologic being assessed. Weighted risk score 4.2

Drug Development

LifeSciVC

FEBRUARY 5, 2025

However, in recent years, huge leaps have been made in drug discovery ranging from novel technologies unearthing new techniques for small molecule development to new modalities like targeted protein degradation that are beginning to open the door to a promising wave of transcription factor-directed therapeutic candidates.

Small Molecule

Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The financial burden of drug development is substantial, often exceeding $2 billion per drug.

Drug Development