Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

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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. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

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Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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DrugBank

JULY 20, 2023

Rare diseases, therefore, present compelling opportunities for Drug Development. We're excited to expand our data offering by launching a new Rare Disease add-on to complement our Clinical Trial dataset. This new resource for rare disease research will be integral to our overall drug development solution.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.

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PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success.

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Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. This can present challenges when attempting to recruit an enriched patient population for clinical trials.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5% That brings us to the product’s approval.

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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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Perficient: Drug Development

AUGUST 2, 2023

For learning purposes, you can request a trial license as well. Purchase/Trial Sitecore TDS and SVS license Step 01: Goto the TDS site Step 02: Click on the Free Trial link Step 03: Click the Try TDS button Step 04: Submit the TDS free trial form. Step 05: After submission, you need to download a package and install it.

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Perficient: Drug Development

OCTOBER 4, 2023

CLIENT An American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods. INDUSTRY BACKGROUND The importance of better understanding and engaging patients and members has never been more important than it is today.

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Have you identified and reached out to the PIs and potential clinical trial sites?

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Cytel

DECEMBER 15, 2023

In clinical trials, high-quality data is essential. It drives the drug development decision-making process and is a requirement for regulatory approval. But while most sponsors develop data strategies for their clinical programs, it often happens late in the development process.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. The draft guidance helpfully adds a few examples of appropriate Type D meeting scenarios, and they are: A specific question about an aspect of a complex or innovative trial design (e.g.,

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Alta Sciences

JANUARY 31, 2024

This article will explore the purpose of all three types of analysis, and how they are used in early drug development. The crucial influence PK/PD can have on modeling and simulation decision-making and drug development risk management depends on the quality of data accessible at specific stages of drug development.

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Perficient: Drug Development

MARCH 27, 2024

You can have a trial or subscription as needed for practical purposes. Create an Asp.Net Core Web API Application now by utilizing the template and install packages Azure.Identity and Azure.Security.KeyVault.Secrets from Tools->NuGet Package Manager->Manage NuGet packages for solution.

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Perficient: Drug Development

AUGUST 14, 2023

Factors to consider: Price Capabilities and features Access level collaborators Easy of use and flexibility: Easy to understand analytics and data Compatibility with Google Analytics 4 Future proof Start with a basic package from a tool like Optimizely Web Experimentation and grow as needed.

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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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KIF1A

APRIL 24, 2023

New information from Dr. Chung about the KOALA study and potential future ASO trial! Please log into the Private Family Resource page on our website to watch a new video from Dr. Chung about the importance of the KOALA study and information about a potential future ASO trial. All KAND families!!! LET’S HELP THEM FLY!

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. Senior Vice President and Head of Global Clinical Development at Regeneron. high dose, 1.6%

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The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. It can simply start with a strategic assessment of your drug product. [i] 89 FR 61474.

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Altus Drug Development

MAY 31, 2022

Effective: Healthcare services should be provided to all who need them based on clinical trials and scientific knowledge. Since insurance providers adjust their packages with large employers based on employee health (among other factors), having a healthier workforce can also mean having a better insurance package.

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Perficient: Drug Development

SEPTEMBER 18, 2024

Getting Started: Prerequisites and Setup Before diving into the setup process, ensure you have: Splunk Cloud Account: An active account (free trial or paid subscription). Universal Forwarder Installation Package: Downloaded for your specific operating system. Run the installer or extract the package to your desired location.

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The Pharma Data

JANUARY 17, 2021

It received FDA guidance January 5 th and is in the midst of preparing the first package of investigational new drug (IND) applications – usually with an n-of-1, for individual patients. Safety is critical in all clinical trials, but with ultra-rare diseases, even greater care is taken. We’re the middleman,” he said.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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The Premier Consulting Blog

APRIL 15, 2024

From a business standpoint, these studies are critical for obtaining funding and being reassured that the drug will show promise once it enters the clinic. However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

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Drug Target Review

DECEMBER 5, 2024

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. The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders.

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Agency IQ

FEBRUARY 12, 2024

Hybrid medicines are defined by the EMA as drug products that depend both on comparisons to a reference product and on new data from clinical trials. As the FDA has previously acknowledged : “Many complex drug products did not exist” when the Hatch-Waxman Amendments were first passed into law. “As

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Agency IQ

MARCH 29, 2024

FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials. What’s new?

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Advarra

JUNE 28, 2022

Failure to Have a Pre-Investigational New Drug (IND) Meeting. There are a myriad of regulations coming into play during the drug development process. Ensure your study has evidence to support the robustness of the assay used in evaluating the clinical trial. Inadequate Support.

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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.

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The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

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Agency IQ

AUGUST 2, 2024

September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.

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Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan drug developers may set higher prices to recoup their return on investment lost due to the haircut.

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Perficient: Drug Development

APRIL 9, 2024

In the future, there will always be a better LLM model to use, but at this time these findings are based on trials of the Oracle Cloud Infrastructure (OCI) shared Cohere Command model, the OpenAI GPT-3.5-Turbo Turbo model and the OpenAI GPT-4 model. It is also a lot faster to respond compared to the OCI shared Cohere Command.

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