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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Alta Sciences

NOVEMBER 5, 2024

Their advantages include ease of scalability and manufacturing, ease of packaging, and high product stability. Drugs can be encapsulated in the form of beads, micro tablets, and pellets, in combination with the liquid formulation. Liquid-filled, hard-shell capsules were introduced in the early 1980s, as an alternative to softgels.

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Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids. 2024 [cited 2024 Oct 28]. Labcompare.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Increased Capabilities for Marketing Cloud and Commerce Cloud Salesforce introduced 26 generative AI capabilities between Marketing Cloud and Commerce Cloud, 14 of which are in GA now, with an additional 14 to arrive by the end of 2024.

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Perficient: Drug Development

OCTOBER 25, 2023

Participating offices that made the biggest impact in their communities qualify for special recognition and bragging rights as the 2024 HAM Champions. LEARN MORE: Read Perficient’s 2022 Community Impact Report So, which office won our 2024 HAM Competition? Stay tuned to find out!

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.

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Agency IQ

FEBRUARY 12, 2024

BY AMANDA CONTI | FEB 7, 2024 6:44 PM CST Quick background: complex and hybrid products Complex generics are defined by FDA as products with a complex active ingredient, formulation, delivery route, dosage form or method of administration. The FDA has taken some actions to make the path to market easier for these products.

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Perficient: Drug Development

SEPTEMBER 25, 2023

UPTIS is expected to be introduced on General Motors passenger vehicles as soon as 2024. Availability of these services will vary depending on the model year, vehicle, trim level, and sometimes selected option packages. As examples of this are the General Motors OnStar, NissanConnect, and Toyota Connected Services systems.

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Perficient: Drug Development

NOVEMBER 22, 2024

Starshot is a game-changer for organizations seeking to elevate their digital strategies, from scalable pre-packaged solutions to AI-driven personalization and seamless updates. Let’s dive into the future of enterprise digital experiences and uncover five ways Drupal Starshot will be a pivotal development for your business.

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Department of Defense administered mefloquine, the synthetic drug developed at Walter Reed in the U.S., Discovering an Antimalarial Drug in Mao’s China." Asimov Press (2024).

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Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. In the U.S.,

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Perficient: Drug Development

SEPTEMBER 16, 2024

The Winter ’25 Salesforce release is rolling out between September and October 2024, bringing exciting updates and new features designed to enhance developer productivity. From adding advanced AI features to boosting platform capabilities, this release is packed with valuable tools for Salesforce developers.

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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.

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. For others this may serve as a reminder of some of the pitfalls that can befall biotech companies this time of year and what the key questions are to ask yourself and the team to manage through the madness and finish strong in 2024. Don’t get me wrong.

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Clinical Trials Trials Disease Treatment 62

Perficient: Drug Development

JANUARY 3, 2024

The working demo will be like this: screencast 2024-01-03 17-47-27 The AEM implementation includes the following parts: A customized AEM Core Teaser component. An AEM servlet to receive the request from the Teaser component dialog, and call the OSGi service, then return the response to the Teaser component dialog UI.

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Packaging Engineering International Research 52

Codon

FEBRUARY 13, 2024

Of course, the models for low and middle-income countries will be heavily reliant on public or philanthropic funding, rather than the profit incentive that drives so much drug development in the West. Asimov Press (2024). Cite this essay: Tom Ireland. Scaling Phage Therapy." DOI: [link] Header image: David S.

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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. The meeting will take place on April 12, 2024, 9 a.m.

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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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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.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” The new draft guidance can be broken into three main parts.

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Production FDA Therapies Biochemical Assays 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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FDA Science Regulations Production 40

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. ” Asimov Press (2024). Mendel achieved this by measuring a small number of easily observable traits—such as seed color and shape—in a simple model system: pea plants.

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Laboratories Research Disease Science 117

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” But despite the law’s age, it is not yet fully operational.

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