Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking.

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KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. The FDA’s Fast Track designation of LX9211 reflects the serious unmet medical need of people suffering from diabetic peripheral neuropathic pain,” said Praveen Tyle, Ph.D., THE WOODLANDS, Texas, Dec.

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Fierce BioTech

APRIL 10, 2024

Staquicini, PhD Duration 60 minutes Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. Redefining Antibody Specificity Profiling for IND swheeler Wed, 04/10/2024 - 17:56 Thu, 06/06/2024 - 11:00 Resource Type Webinar Kris Raghavan, PhD Fernanda I.

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The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. The target action date for the FDA decision is September 30, 2022. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

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The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. This is a question that sponsors have been struggling with for quite some time.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here. The Altascientist : Issue No. Read or listen now. Want to see more?

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND.

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The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). The FDA’s Fast Track designation is a process designed to expedite or facilitate the review of product candidates to treat serious conditions and fill an unmet medical need.

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Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).

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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. What specific patient populations are benefiting the most from these developments?

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Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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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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PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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The Pharma Data

OCTOBER 27, 2020

(NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. “We

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. About Eisai Co.,

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? Our Phase IIb asset, pirepemat, is being developed to improve balance and reduce falls by strengthening nerve cell signalling in the prefrontal cortex via action at 5HT7 and alpha-2 receptors.

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The Premier Consulting Blog

JULY 9, 2023

These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product). 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

DECEMBER 15, 2020

TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. With no FDA-approved treatments for this condition, current guidelines recommend sedative medications to maintain a light level of sedation in adult patients, which is frequently not achieved with commonly used therapies.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. It also means sponsors are less likely to waste time and resources developing programs that don’t work for patients.”

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

What makes advances like this especially important is that only 1 in 10 drug candidates entering human clinical trials ultimately receives approval from the Food and Drug Administration (FDA) [2]. For those drug candidates that are ultimately doomed, “failing early” is key to reducing drug development costs.

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The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. ” Ms.

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The Pharma Data

OCTOBER 28, 2020

Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. A summary of the company’s work to date on COVID-19 can be found here. mRNA-1273 currently is not approved for use by any regulatory body.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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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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