The Premier Consulting Blog

NOVEMBER 20, 2024

For drugs with FDA Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), and EMA PRIority MEdicines designation (PRIME), all clinical, non-clinical, and CMC requirements are still required for regulatory approval, despite being on pathways for an expedited approval process.

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Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.

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DrugBank

JULY 24, 2024

Breaking New Ground with PROTACs One of the standout innovations in this space is the development of proteolysis-targeting chimeras, or PROTACs. These multifunctional small molecules are like tiny spies, hijacking the body’s natural protein degradation system to remove unwanted proteins.

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Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades.

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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.

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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.

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LifeSciVC

JANUARY 3, 2024

Recognizing the therapeutic potential of effectively disrupting the CBM complex in the NF-kB pathway, using our technology, we have developed small molecules that we believe to be the first and only inhibitors of MALT1’s scaffolding function.

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DrugBank

MAY 15, 2024

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding. One approach is to look beyond the traditional drug molecule.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans. Is fit-for-purpose?

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Alta Sciences

SEPTEMBER 27, 2024

The growing understanding of the immune system's role in various diseases, along with advancements in drug development, have led to a natural evolution from traditional vaccines, small molecules , and cytokines , to increased targeted biologics and innovative approaches in gene therapy and vaccines.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Conversations in Drug Development Trends

APRIL 4, 2024

Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures. Quality Control Batches : These batches are utilized to ensure the assay’s accuracy when measuring various study samples.

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PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Small molecule GLP1s?

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Drug Target Review

MARCH 1, 2024

How significant are the results in terms of advancing TCR-T cell therapy and AMP immunotherapy for the treatment of solid tumours? We have already applied this approach to several important tumour targets where enhancements in TCR-T therapy may lead to important gains in clinical benefit, including mutated KRAS, NY-ESO, and HPV E7 antigens.

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Creative Biolabs

JUNE 29, 2023

At present, a large number of G protein-coupled receptor-targeted drugs have been marketed, and a large number of drugs are under development. GPCR is the most valuable target for drug development, and more drugs will be used to treat various diseases in the future.

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PPD

JUNE 27, 2024

In recent years, AA has followed in the footsteps of other dermatology indications — including psoriasis and atopic dermatitis — with growing research and clinical studies focusing on small molecules with broad cellular effects (JAK and PDE4 inhibitors) and cytokine-specific molecules antagonists (IL-23, Th2 and IL17) to treat the condition.

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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. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

JANUARY 25, 2021

–( BUSINESS WIRE )– Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. 26, 2021 13:00 UTC. FREDERICK, Md.–( About VLX-1005.

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PerkinElmer

JANUARY 21, 2021

Using drugs that are already on the market was the quickest path forward to evaluate these compounds and possibly help patients now because novel drug development typically takes years. Scientists needed to evaluate the field of potential drugs-and fast. COVID-19 is a difficult disease to understand and treat.

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NIH Director's Blog: Drug Development

OCTOBER 11, 2022

For clinical researchers, click chemistry has emerged as a workhorse in drug discovery and the improved targeting of cancer chemotherapies and other small-molecule drugs. The approach also is being used to improve delivery of antibody-based therapies and to create new biomaterials. 2004 Jul;11(7):1009-1016.

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Drug Target Review

JULY 7, 2023

There is a clear need for new and approved, safe, effective and innovative targeted therapies to address the underlying causes of autoantibody diseases. The power of precision therapy Targeted — or precision — therapy, a technique that has been honed for many years in cancer treatment, is now being applied in a wider context.

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PLOS: DNA Science

SEPTEMBER 5, 2024

The most groundbreaking cancer drug approval was for Gleevec , with a mere 3-month trajectory at FDA before its approval in 2001. Gleevec is a small molecule that interferes with entry of an enzyme – a tyrosine kinase – that enables growth signals to enter specific cells and trigger division.

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Drug Target Review

MAY 1, 2024

T-DM1, for example, is approved in patients with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy. What innovative strategies are being developed to improve drug stability? Jamie Rich, PhD is Senior Director of Technology, ADC Therapeutic Development at Zymeworks Inc.

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Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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Vial

FEBRUARY 19, 2024

Explore the groundbreaking VersAptx bioconjugation platform, designed to elevate cancer therapies and uncover the delicate balance between clinical excellence and commercial viability in the dynamic landscape of pharmaceuticals. Can you elaborate on how the platform allows your company to tailor therapy? Ahmed Hamdy: Absolutely.

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New Drug Approvals

DECEMBER 3, 2022

852808-04-9 ABT-737 is a small molecule drug that inhibits Bcl-2 and Bcl-xL , two members of the Bcl-2 family of evolutionarily-conserved proteins that share B cl-2 H omology (BH) domains. “Bcl-2 inhibitors: small molecules with a big impact on cancer therapy.” ABT-737 Molecular Weight 813.43

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Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

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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

JANUARY 10, 2021

Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE397, a small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, for the treatment of patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. Chief Scientific Officer, IDEAYA Biosciences.

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Drug Target Review

JULY 12, 2023

We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy. With this drop off, the goal is to reach a near-zero drug trough before the 24-hour mark.

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The Pharma Data

JANUARY 14, 2021

”) platform to transform cancer drug development and identify patients who will benefit from its targeted oncology therapeutics, today announced the pricing of a public offering of 4,285,715 shares of its common stock at a public offering price of $14.00 DALLAS , Jan.

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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? However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

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The Pharma Data

OCTOBER 18, 2020

Separate from the AML trial, Aptose is conducting a Phase 1 a/b dose escalation study with CG-806 in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies. About CG-806.

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The Pharma Data

OCTOBER 21, 2020

Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”. “In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can.”

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NIH Director's Blog: Drug Development

MAY 21, 2020

Just one infusion of this combination antibody therapy lowered the amount of viral genetic material in the animals’ lungs by as much as 30 percent compared to the amount in untreated animals. Meanwhile, there’s been other impressive recent progress towards the development of monoclonal antibody therapies for COVID-19.

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