Alta Sciences

OCTOBER 31, 2023

Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri pmjackson Tue, 10/31/2023 - 16:08 Laval, Québec, October 31, 2023 – Altasciences is pleased to announce the completion of its laboratory facilities in Columbia, MO. This is Altasciences’ third purpose-built laboratory.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected.

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PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. This can offer advantages in terms of continuity and efficiency.

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The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,

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Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. Tags Bioanalysis Weight 15

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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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DrugBank

JUNE 27, 2024

Drug repurposing’s potential to target undruggable molecules is showing huge promise for its ability to accelerate the development of new therapies and improve patient outcomes. Challenges of Drug Repurposing Drug repurposing shows a great deal of promise but it isn’t without its challenges.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

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Conversations in Drug Development Trends

AUGUST 14, 2024

Historically, these indications have challenged the one-size-fits-all treatment approach due to patient variability, such as genetic differences in drug metabolism and underlying health conditions. Hematological cancer cells can also develop resistance to therapies over time, reducing treatment effectiveness.

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Vial

MAY 20, 2024

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

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Agency IQ

DECEMBER 15, 2023

Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. They don’t like what they see. The comment period for the proposed rule closed on December 4 th , 2023.

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Laboratories Science FDA Regulations 40

Drug Target Review

FEBRUARY 19, 2024

A pivotal moment for me was when I realised that if I understood disease mechanisms on a molecular level, I could be part of an industry that helps develop medicines/therapies for those who need them most. I am proud to have contributed to the advancements in monoclonal antibody discovery and development. BECOME A ROLE MODEL!

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories.

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The Pharma Data

OCTOBER 27, 2020

Dry AMD is one of the leading causes of vision loss globally and gene therapies hold tremendous promise for this disease. Delivering gene therapy directly to the site of disease through a subretinal injection is a proven approach; however, the current method requires a vitrectomy. at Ophthalmic Consultants of Boston. Source link.

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The Pharma Data

JANUARY 24, 2021

a biotechnology company developing renewable stem cell-derived T cell therapies for cancer and other immune disorders, announced today the appointment of Chris Bond , Ph.D. Bond has extensive experience in the discovery and development of adoptive cell therapies, monoclonal antibodies, and cellular engineering and genome editing.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

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Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing may help confirm a clinical diagnosis, help predict disease prognosis and progression, facilitate early detection of symptoms, allow for family planning and genetic counseling, inform optimal treatments and therapies, and/or promote enrollment in clinical trials. What are the benefits of using Invitae vs another lab provider?

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Drug Target Review

SEPTEMBER 18, 2024

What specific cost-cutting measures can AI provide in the manufacturing process of cell and gene therapy, and how do these compare to traditional methods? The cell and gene therapy (CGT) space provides a great example of the potential of AI. AI can vastly improve cell culture, a critical step in cell therapy production.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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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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DrugBaron

JULY 19, 2022

Despite the current hype around so called “advanced therapies”, which range from gene editing to cell therapies, and the inexorable advance of biologic therapeutics such as monoclonal antibodies, even in 2022 the majority of drugs in development and reaching patients are still small organic molecules.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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NIH Director's Blog: Drug Development

DECEMBER 4, 2018

National Laboratory, which is orbiting about 400 kilometers above Earth. This blood vessel-tissue interface can prevent certain molecules—including some potentially beneficial therapies—from entering the brain. If all goes as planned, SpaceX and its special biomedical cargo will lift off from Cape Canaveral, FL at 1:16 p.m.

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DrugBank

FEBRUARY 19, 2025

This discovery highlights how AI can uncover new biological insights and enable the development of targeted therapies for diseases with unmet medical needs. Traditional drug discovery relies on the time-consuming and often inefficient process of designing, synthesizing, and testing molecules.

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The Pharma Data

MARCH 4, 2021

The sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation, characterized by elevated blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels.

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The Pharma Data

JUNE 26, 2021

Libtayo is the first immunotherapy to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial, and with this first-in-class approval has the potential to transform treatment for patients in Europe whose cancer has progressed despite HHI treatment ,” said Israel Lowy, M.D.,

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PerkinElmer

FEBRUARY 24, 2021

Reduce the time and costs for drug development Drug discovery takes an extraordinary amount of time and money to complete. The use of ML/DL in high content screening of thousands of potential drug candidates reduces the time, personnel, and costs needed to complete the screening and data analysis.

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PPD

NOVEMBER 14, 2023

As such, success often hinges on getting the right resources in place at the right time — which means having a partner that is an expert at resourcing, recruiting, onboarding and training, not just in the clinical development field, but in the unique world of FSPs.

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The Pharma Data

DECEMBER 28, 2020

. Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B /2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease.

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Predictive Oncology

FEBRUARY 7, 2023

With its technology, the company wants to change the way that biopharma companies plan clinical trials and develop oncology drugs. This is all about getting the right drugs to the right patients at the right time as soon as possible to personalize the treatment of their therapies, primarily in oncology,” said Vennare.

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The Pharma Data

JANUARY 17, 2021

Traditional companies have neither the technologies nor the financial incentives needed to develop ultra-rare therapies. Working closely with Ionis, “We connect the need to the drug development engine. Crooke, therefore, created n-Lorem Foundation to do that charitably. We’re the middleman,” he said.

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Precision for Medicine

JANUARY 23, 2023

The combined offerings under QuartzBio provide scientific and operations teams in drug development with an agile, user-friendly data management platform that enables enterprise-level visibility across the lifecycle of their sample and biomarker data. Canada, Europe and Australia. Canada, Europe and Australia.

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The Pharma Data

DECEMBER 17, 2020

If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. , and Roche will develop, manufacture and distribute it outside of the U.S. who require oxygen therapy due to COVID-19, OR. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION.

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