Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning. View the full library of The Altascientist publications. Image thumbnail-qh33.jpg

Drug Development 52

Drug Development Clinical Trials Small Molecule Drugs 52

LifeSciVC

AUGUST 5, 2024

We are constantly reminded how we are in the midst of an artificial intelligence revolution of the drug development process which promises to completely transform how we develop drugs with increases in productivity of an order of magnitude or more. One final parallel to 2001.

Molecular Biology 88

Molecular Biology Production Drug Development Small Molecule 88

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.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. July 31, 2024. [ii]

Pharmacokinetics 52

Pharmacokinetics Drugs FDA Production 52

Alta Sciences

NOVEMBER 5, 2024

Last but not least, they offer patient benefits with increased bioavailability and sustained release drug delivery. This blog was originally posted 07/26/2021 and updated on 11/05/2024 Reference [link] Image Thumbnail_Blog-LFHSCs-alt.jpg Synopsis Liquid-filled capsules can be rapidly developed and tested, moving quickly from R&D to clinic.

Marketing 52

Marketing Small Molecule Production Pharmaceuticals 52

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.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

Broad Institute

AUGUST 13, 2024

Brain Health Scientific Community By Rose Circeo August 13, 2024 Breadcrumb Home Brain Health Brain Health Scientific Community PI Topic Paola Arlotta (Harvard) 3D cerebral organoid culture technologies to assess the molecular laws that govern the birth, differentiation, and assembly of the human cerebral cortex in health and disease.

Disease 52

Disease Small Molecule Engineering Treatment 52

The Pharma Data

DECEMBER 14, 2020

billion by 2024, according to GlobalData, with the U.S. The ability of a drug candidate to cross the blood brain barrier is of critical importance in treatment outcomes for CNS and brain cancers. . Our mission is to transform and accelerate the cancer drug development process.

Clinical Trials 52

Clinical Trials DNA Drugs Therapies 52

Elrig

APRIL 29, 2024

There, I supported AI-enabled DD efforts in their small molecule portfolio. Joining Isomorphic Labs in October 2024, I’m thrilled to be part of their mission to revolutionize DD through AI/ML. Fascinated by the potential of AI in medical research, I transitioned to BenevolentAI in early 2023 as a Biology Project Leader.

Bioinformatics 59

Bioinformatics Drugs Molecular Biology Cell Based Assays 59

Agency IQ

APRIL 19, 2024

BY LAURA DIANGELO, MPH | APR 15, 2024 10:06 PM CDT FDA’s Center for Drug Evaluation and Research (CDER) has a new initiative to advance clinical trials Quick background: The push for “innovation” in clinical trial design. So, adding new drug development tools is naturally, maybe not going to go over so well.”

Clinical Trials 40

Clinical Trials Trials Science FDA 40

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

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

APRIL 19, 2024

BY AMANDA CONTI | APR 16, 2024 8:21 PM CDT Quick background on multiple myeloma Myeloma is a blood cancer in which B cells, a type of immune cell, overproduce plasma cells. Note: Both analyses focused only on studies of small molecules, antibodies and biologics; studies of CAR T therapies were not included. FDA-2024-N-1179

FDA 40

FDA Disease Trials Clinical Trials 40

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.

Science 40

Science FDA Trials Clinical Pharmacology 40

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. What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design.

FDA 40

FDA Science Clinical Trials Trials 40

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.

Drug Development 122

Drug Development Virus Vaccine Government 122

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 81

Treatment Clinical Trials Small Molecule Therapies 81

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Trials 52

Sygnature Discovery

OCTOBER 10, 2023

“As part of building and extending Sygnature’s neuroscience drug discovery platform and future direction, we have an ethos to humanize the drug discovery process where feasible to elevate our level of understanding of how novel small molecule compounds work.

Small Molecule 52

Small Molecule Drugs Disease Clinical Trials 52

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 59

Drug Development Bioinformatics Drugs Small Molecule 59

LifeSciVC

FEBRUARY 18, 2025

While the DGCs functional importance was understood as early as the 1980s, a unified picture of its molecular architecture has remained elusive, hampering efforts to develop truly targeted therapies. 2024), Wan et al. These findings also provide a roadmap for the development of sarcoglycan-directed small molecule correctors for LGMDs.

Small Molecule 72

Small Molecule Therapies FDA Approval Drug Development 72

Drug Target Review

DECEMBER 11, 2024

2024 May 24;21(7):64361. Nature Reviews Drug Discovery. 2024 May 8;630(8016):493500. The company is also leading the Long Term Cancer Survivor initiative, a global project to sequence immune repertoires of cancer survivors, aiming to develop next-generation cancer therapies. Nature Reviews Clinical Oncology.

Immune Response 52

Immune Response Engineering Therapies Small Molecule 52