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.)

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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