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.

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Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. This orally available small molecule binds to the bromodomain of CBP/p300 in a highly specific manner.

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Small Molecule Therapies Regulations Treatment 105

Drug Target Review

NOVEMBER 1, 2024

Strategies for the synthesis and development of complex active pharmaceutical ingredients While the prevalence of biologics has grown within the pharmaceutical sector over recent decades, small molecules remain important and can offer significant advantages. References [1] Clemons et al.

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Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Conversations in Drug Development Trends

APRIL 4, 2024

Since reaching full implementation on January 21, 2023, numerous regulatory bodies have adopted the ICH M10 standards. 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.

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LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Small molecule GLP1s?

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. 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

To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. 6 In all these examples, an effective backbone drug was first developed, before adding one or more drugs to establish the new regimens. link] Accessed October 2023. Accessed October 2023.

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Alta Sciences

JUNE 2, 2023

Expert Support for Your IND/CTA Requirements rmaloney Fri, 06/02/2023 - 17:33 HTML Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible.

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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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Treatment Clinical Trials Clinical Research Small Molecule 52

The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. It can simply start with a strategic assessment of your drug product. [i] FDA-2023-N-2850.

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Pharmacokinetics Drugs FDA Production 52

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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Small Molecule Clinical Development Disease Science 52

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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FDA Small Molecule Science Immune Response 40

Vial

DECEMBER 11, 2023

Hepatitis C Virus (HCV) Drug Development There is an urgent need to develop novel, efficient, reliable, and cost-effective diagnostic technologies and therapeutic and immune prophylactic interventions to manage HCV. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs.

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Clinical Research Therapies Research Vaccine 52

Drug Target Review

JULY 12, 2023

If there is robust gene expression data for the aspect of a disease that we are aiming to reduce or eliminate, the DCT mechanism will find results that can lead us to promising new drug candidates. We are pleased that to date our lead product candidate has aligned DCI profiles as expected.

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Biochemical Assays Treatment Bioinformatics Disease 98

Elrig

APRIL 29, 2024

Fascinated by the potential of AI in medical research, I transitioned to BenevolentAI in early 2023 as a Biology Project Leader. There, I supported AI-enabled DD efforts in their small molecule portfolio.

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Bioinformatics Drugs Molecular Biology Cell Based Assays 59

Agency IQ

APRIL 19, 2024

As the FDA’s Center for Drug Evaluation and Research (CDER) characterized it in a 2023 call for comments : “Evolving understanding of disease biology and molecular pharmacology, advancements in drug discovery, and growth in novel therapeutic platforms (i.e., many overlap with the goals of this latest initiative.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Drug Target Review

FEBRUARY 15, 2024

11 Health agencies globally must collaborate with academic research centres and industry to address this important gap in drug treatments for pandemic-prone pathogens. Research teams must be able to rapidly identify small molecules that target biochemical pathways that are conserved across multiple viruses within a family.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

APRIL 19, 2024

The most recent accelerated approvals occurred in August 2023: Elrexfio (elranatamab-bcmm; Pfizer) and Talvey (talquetamab-tgvs; Janssen). These drugs were both approved for relapsed or refractory (RR) MM patients who had already received at least four prior lines of therapy.

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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. Initial approval in 2023: FDA, U.S. Then 1 packet to be used twice daily thereafter.

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Treatment Clinical Trials Small Molecule Therapies 81

Sygnature Discovery

OCTOBER 10, 2023

On 10th October 2023, Sygnature Discovery, a world-leading integrated drug discovery provider and non-clinical solutions provider, has announced a scientific collaboration with human induced pluripotent stem cell (iPSC) experts, Axol Bioscience.

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Small Molecule Drugs Disease Clinical Trials 52

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

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