Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

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PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98

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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Drug Development Treatment FDA Approval Drugs 52

The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacokinetics Pharmacokinetics examines the absorption, distribution, metabolism, and excretion properties of a drug.

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Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. Microbiotica, a pioneering company that has developed a Discovery Platform that has paved the way for the creation of Live Bacterial Products (LBPs).

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Treatment Pharmaceuticals Pharmacokinetics Trials 122

DrugBank

MARCH 7, 2024

Pfizer, for instance, is eyeing a significant share of this space, working on an oral GLP-1R agonist, Danuglipron, with the intention to introduce a once-a-day version of its weight management product. Moreover, smaller companies like Altimmune are seeking partnerships to propel the development of their experimental drugs.

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Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 98

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.

Drugs 52

Drugs Pharmacokinetics FDA Production 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 42 U.S.C. §

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Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. Catch up on what you may have missed below! Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. References Köhler G, Milstein C. 2018;10(4):539–46.

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

DECEMBER 14, 2020

The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. before expanding it into Europe.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

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Biochemical Assays Treatment Bioinformatics Disease 98

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. The new formulation resulted in a drug product that was very viscous.

Drugs 52

Drugs Packaging Clinical Pharmacology Small Molecule 52

The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs. Our experts are ready to assist you with your next adaptive oncology MRCT.

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Trials Clinical Trials Regulations FDA 80

Agency IQ

MAY 17, 2024

Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. During a meeting this week, FDA speakers highlighted the uniqueness of this redesigned meeting type in allowing sponsors to explain how they’ve addressed challenges encountered during product development.

Science 40

Science FDA Drugs Production 40

The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. About people of further than 140 ethnicities work at Novartis around the world.

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Disease Treatment Pharmacokinetics FDA 52

The Pharma Data

AUGUST 29, 2020

“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We You should not place undue reliance on these statements.

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Treatment Disease Small Molecule Production 52

The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. The Company plans to initiate a Phase 2 trial within the next several months.

Treatment 40

Treatment Trials FDA Hospitals 40

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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Production Trials Treatment Disease 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

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

AUGUST 30, 2021

Part B of the Phase 3 trial was informed by Part A , an open-label, single-ascending-dose, sequential cohort Phase 2 trial designed to assess the pharmacokinetics and safety of Dupixent in children aged 6 months to 5 years with uncontrolled severe atopic dermatitis.

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Trials Disease Treatment Clinical Trials 52

New Drug Approvals

JANUARY 9, 2024

Inhibitors of CDK7 are currently being developed for the treatment of cancer. For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. mol) in THF (700mL) at -78 °C over a period of 30 min.

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Production DNA RNA Regulations 62

Agency IQ

DECEMBER 11, 2023

While the primary developer of the draft guidance was the FDA’s Oncology Center of Excellence (OCE) as part of its “Project Equity,” the FDA’s three life sciences product centers “also contributed to this collaborative effort,” according to a statement from the FDA.

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FDA Research Clinical Trials Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

FDA 40

FDA Trials Therapies Regulations 40

Alta Sciences

DECEMBER 31, 2024

Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drug development (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.

Therapies 52

Therapies Pharmacokinetics Pharmacogenetics Clinical Trials 52

PPD

APRIL 14, 2025

Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies. Were also uniquely able to deliver a full suite of end-to-end offerings that include: Thermo Fisher Scientific manufacturing for production continuity from clinical trials to commercial scale.

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

The Premier Consulting Blog

APRIL 25, 2023

Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drug development and approvals. Synthroid® oral tablets) were marketed as unapproved drugs for the treatment of hypothyroidism in the US.

FDA 52

FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

Drug Target Review

OCTOBER 16, 2024

My clinical background as a physician led me to drug development, where I realised I could have an even broader impact on patient well-being. 1,2 Moments like these, where we bring new mechanisms through clinical testing, reaffirm my commitment to drug development. This flexibility fosters creativity and productivity.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

DrugBank

FEBRUARY 26, 2025

In 2020, MIT researchers demonstrated the potential of AI by discovering salicin , a novel antibiotic that targets bacterial energy production. This discovery represents a shift in how antibiotics are identified, showcasing the potential of AI to uncover entirely new drug classes.

Therapies 52

Therapies Pharmaceutical Companies Pharmacokinetics Treatment 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, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. Pivotal (i.e.,

FDA 40

FDA Science Small Molecule Immune Response 40

Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

JULY 28, 2023

This is referred to as “sole source” of a service, and might occur in situations where one company has a brand name product that does not have competition in the marketplace or could occur when a vendor retains significant advantage over competition (e.g., Industry wants its products reviewed quickly, efficiently and predictably.

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