The Pharma Data

DECEMBER 10, 2020

Sildenafil, Trazodone Tablets Recalled After Being Packaged Together. 10, 2020 — Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKARE because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company.

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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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The Open Targets Blog

JANUARY 30, 2025

gget ( [link] ) is a free, open-source command-line tool and Python package designed to enable efficient querying of large genomic databases, such as Ensembl, UniProt, and NCBI. Amongst other tasks, gget opentargets can quickly find diseases and drugs associated with a specific gene. What is gget?

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PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. RWE is transforming rare disease drug development, providing the insights needed to overcome unique challenges.

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Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Most of the LLM activity in the drug discovery space in 2023 was reported as preprints from academic groups. Most of the drug discovery examples were underwhelming. Here’s the structure of Part II.

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Antidote

JULY 27, 2023

Clinical trials evaluate new drugs, devices, packaging, and behaviors in order to determine if these potential therapies work for particular conditions or patient populations.

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Drug Channels

DECEMBER 9, 2022

Leslie and Jinghong discuss the terms of health insurance startups CEOs’ compensation packages. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. They explain why the reported CEO total compensation numbers are deceiving. Read on for Leslie’s and Jinghong’s insights.

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Molecular Design

DECEMBER 31, 2023

BW2014 has been heavily cited in the drug discovery literature (it was cited as the first reference in the ACS assay interference editorial which I reviewed in K2017 ) despite providing nothing in the way of practical advice for dealing with nuisance behavior. Most PAINS function as reactive chemicals rather than discriminating drugs. [It

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ASPET

SEPTEMBER 16, 2024

PF-06952229 (MDV6058) selected using rational drug design is a potent and selective TGFβRI inhibitor (TGFβRIi) with a relatively clean off-target selectivity profile and good pharmacokinetic properties across species. The compound presents an acceptable ICHS9 compliant profile for the intended-to-treat cancer patients.

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Fierce BioTech

OCTOBER 8, 2024

Ana Kuschel Francis Carroll Sonia Adamidis Marc Uerdingen Duration 90 Minutes Join West experts to learn about solutions for today’s drug products and tomorrow’s novel applications and gain insights to understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery.

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Drug Target Review

JUNE 9, 2023

What were the key findings or achievements from the pre-clinical research conducted by the Adaptive-Genentech partnership that led to the submission of the investigational new drug (IND) application? Under our Genentech collaboration, we cannot comment on specific results of a TCR data package selected by Genentech.

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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. Cavlan notes that underpinning this use of AI in early discovery is the need to better understand biology.

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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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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. References Evaluate.

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Broad Institute

JULY 10, 2024

A three-drug cocktail known as Trikafta has greatly improved patient quality of life since its development in 2019, but can cause cataracts and liver damage and must be taken daily at a cost of about $300,000 per year. The new approach also generated 3.5

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? 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.

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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. The overall development strategy for GT123 was to include a complete CMC package. Human factors.

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Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

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FDA Law Blog: Biosimilars

AUGUST 27, 2023

Drug manufacturers have had electronic systems in place since 2017. FDA will exercise enforcement discretion concerning the implementation of the electronic interoperable exchange of information between trading partners to the package level. Guidance at 4. So what is FDA going to do? So what is FDA going to do?

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DrugBank

JULY 20, 2023

Rare diseases, therefore, present compelling opportunities for Drug Development. In the United States, the Orphan Drug Act has provided a framework for this support since 1983 by issuing orphan designations to drugs being investigated for treating a rare disease. At any given time, millions of people ( 3.5–5.9%

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Fierce BioTech

JANUARY 3, 2025

This joint webinar presentation by West and Groninger, explores the unique challenges of Cell and Gene Therapies, mRNA LNP therapeutics particularly regarding cold storage requirements and their impact on packaging solutions. Click here to login. Listing Image WestPharma_ListingLogo_250x190.png On Demand Start Date Wed, 02/12/2025 - 11:00

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Fierce BioTech

JANUARY 3, 2025

Innovations in aseptic processing for container closure systems dwunderlin Fri, 01/03/2025 - 14:26 Wed, 02/12/2025 - 10:00 Resource Type Webinar Jim Thompson Julian Petersen Duration 60 Minutes The pharmaceutical landscape is shifting from blockbuster drugs to personalized treatments, driving the need for innovative container closure systems.

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The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,

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Fierce BioTech

DECEMBER 12, 2023

From Bench to Bedside and Back Again: Strategies for effectively leveraging preclinical data to accelerate Inconsistent preclinical data collection can lead to compounding costs in drug discovery. Is your organization harnessing the full potential of preclinical metadata for analyses, internal decision making, and to support R&D packages?

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such. That brings us to the product’s approval.

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Drug Target Review

AUGUST 6, 2024

A number of areas represent significant opportunities for Antibody Drug Conjugates (ADCs) beyond oncology, leveraging their ability to deliver therapeutic agents specifically to diseased cells or tissues while minimising off-target effects. Oncology drugs often command high prices, potentially leading to higher ROI.

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Codon

AUGUST 15, 2023

A good idea — presented clearly, backed by evidence, and packaged in a story — can help you raise money for a cause, rally people to an idea, or shift the directions of a field. Adam Green wrote a brilliant blog, “ A Future History of Biomedical Progress ,” that helped him start an AI drug discovery company.

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Practical Cheminformatics

SEPTEMBER 12, 2021

In this example, we'll be using the chemfp package by Andrew Dalke. Chemfp is a great package. If you're using it for production drug discovery, you should buy a license. Chemfp has both free and paid tiers. With the free tier, you can perform similarity searches on smaller datasets, like the one we're using here.

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Practical Cheminformatics

JULY 5, 2023

When working in drug design, we often need filters to identify molecules containing functional groups that may be toxic, reactive, or could interfere with an assay. This functionality is available in the pip installable useful_rdkit_utils package that's available on PyPI and GitHub. Applying these filters is easy.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. The Importance of Quality and Reliability In the high-stakes world of drug development, quality isn’t just important it’s everything. Assessing Your Technical Needs Every drug is unique, and so are its manufacturing requirements.

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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. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

Instead of the black, printed stripes of the Universal Product Codes (UPCs) that we see on everything from package deliveries to clothing tags, they used short, unique snippets of DNA to label cells. In the next key test, the researchers exposed a mixture of 25 barcoded lung cancer cell lines to approved cancer drugs. Nat Biotechnol.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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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. In combination, they provide confidence in dose escalation or protocol adaptation decisions, which ultimately benefit patients who often have critical and life-limiting diseases.

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The Premier Consulting Blog

MAY 4, 2023

The global ophthalmic drugs market size was valued at $33.81 Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. Now, these companies are required to comply with new guidance from the U.S.

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Molecular Design

AUGUST 9, 2020

Those attempting to use text mining and machine learning to prioritize drugs for repurposing should take note of the views expressed in this tweet. The idea behind drug repurposing is very simple. One rationale for drug repurposing is that the target(s) for the drug may also have a role in the disease that you’re trying to treat.

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