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. 3D rendering of Antibody Drug Conjugate Molecules.

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Alta Sciences

NOVEMBER 13, 2024

Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.

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New Drug Approvals

JUNE 5, 2025

Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 nM) and cell based assays ( EC 50 =89 nM).

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ASPET

MAY 22, 2024

Our findings emphasize the importance of metformin dose selection based on pharmacokinetic parameters for pre-clinical pharmacological studies. Metformin was quantifiable in the CSF at 30 minutes but decreased over time, with concentrations lower than those in the brain across all doses.

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Drug Target Review

AUGUST 7, 2024

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

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Conversations in Drug Development Trends

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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Alta Sciences

OCTOBER 5, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

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Alta Sciences

OCTOBER 31, 2023

“Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.” Altasciences helps sponsors get better drugs to the people who need them, faster.

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Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

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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

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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The Premier Consulting Blog

JUNE 8, 2023

In this blog post, we will share valuable strategies and insights for conducting an optimal meeting and navigating the recovery process to get your drug development program back on track if needed. Preparation To ensure a successful outcome for your 505(b)(2) pre-IND meeting, thorough preparation is key.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Since there was no change in drug substance, the sponsor was able to reference the DMF.

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Alta Sciences

SEPTEMBER 22, 2023

Mastering Drug Safety: Your Passport to Successful Pharmacology tchichekian Fri, 09/22/2023 - 13:36 HTML Navigating the Depths of Safety Pharmacology Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin.

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Alta Sciences

APRIL 10, 2025

Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS pmjackson Thu, 04/10/2025 - 19:59 As a leading partner in ocular therapy, Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.

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Alta Sciences

NOVEMBER 20, 2024

In addition to clinical conduct, Altasciences supported Metsera with its proactive drug development solution , including nonclinical, bioanalysis, CRO and program management services for several additional therapeutic candidates. Altasciences helps sponsors get better drugs to the people who need them, faster.

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Alta Sciences

SEPTEMBER 20, 2023

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. Altasciences helps sponsors get better drugs to the people who need them, faster.

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The Pharma Data

AUGUST 28, 2020

The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.

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Alta Sciences

MAY 28, 2024

This marks the ninth year that Altasciences, a fully integrated drug development solution company, has been deemed a top performer. Clinical Leader and Life Science Leader teamed up with ISR Reports to assess 42 CROs on more than 20 performance metrics in ISR’s annual CRO Quality Benchmarking survey.

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The Pharma Data

MAY 2, 2022

Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD).

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Alta Sciences

OCTOBER 9, 2024

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. These honorees, from the clinic to the C-suite, are making meaningful contributions to their fields and striving to improve outcomes for patients around the world.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.

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Sygnature Discovery

JANUARY 13, 2022

He gained a PhD in Clinical Pharmacology from the University of Lyon and an MD from Université Paris Diderot (Paris VII), and has since spent more than 35 years in the pharmaceutical, biotech and medical sectors in Europe and North America.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.

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Alta Sciences

JULY 25, 2024

39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I An increasing number of advanced methods for dermal drug delivery can contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. The Altascientist: Issue No. View the podcast. The Altascientist: Issue No.

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DrugBank

FEBRUARY 9, 2023

3 Research Focus: Network-based drug repositioning strategy to identify drugs targeting obesity and type 2 diabetes. retrieved the drug targets from DrugBank , which they used to establish the relationship with the disease modules, finally predicting drugs that can target these modules effectively. Dutta et al.

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Drug Target Review

MAY 7, 2024

How do AI-enhanced approaches accelerate the drug development process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.

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New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). 7 March 2023. .

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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. . - Electronic security access to the pharmacy and video monitoring. - 24/7 monitoring of temperature and humidity.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. Dr. Löbenberg. ” Prof.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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The Pharma Data

NOVEMBER 1, 2020

CAMBRIDGE, England–( BUSINESS WIRE )– Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), has appointed Dr Suhail Nurbhai as Chief Medical Officer (CMO) with immediate effect. 2, 2020 08:00 UTC. This press release features multimedia.

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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. Read the blog. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here.

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The Premier Consulting Blog

NOVEMBER 4, 2023

Key to the IND opening studies is that the CMC information is sufficient to support the safety of the drug substance and drug product and establish the phase-appropriate quality of the drug product. Other safety considerations for the drug substance include potential impurities, such as process impurities and degradants.

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New Drug Approvals

SEPTEMBER 10, 2024

. “In Vitro Metabolism of Slowly Cleared G Protein–Coupled Receptor 139 Agonist TAK-041 Using Rat, Dog, Monkey, and Human Hepatocyte Models (HepatoPac): Correlation with In Vivo Metabolism” Drug Metabolism and Disposition. 49 (2): 121–132. doi : 10.1124/dmd.120.000246. 120.000246. PMID 33273044. S2CID 227282766. “S180. .

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