Drug Patent Watch

MARCH 12, 2025

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

Drugs 87

Drugs Packaging Production Drug Development 87

Drug Target Review

JUNE 16, 2025

G protein-coupled receptors (GPCRs) are a highly validated drug target family – accounting for 30-35 percent of all approved drugs. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

Disease 59

Disease Therapies Small Molecule Immune Response 59

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

Drugs 75

Drugs Packaging Compliance Regulations 75

Drug Target Review

MAY 14, 2025

Introduction and background Singh: How do we bring scientists working in drug discovery into the world of AI? Recently, we’ve been pursuing AI product initiatives that have made me consider why people might be resistant to AI tools, what AI tools are capable of in drug discovery, and their limitations.

Drugs 69

Drugs Science Government Production 69

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

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.

Packaging 52

Packaging Pharmaceuticals Production Drugs 52

Predictive Oncology

JUNE 5, 2025

Through this program, investigators or technology transfer offices with potential oncology drug candidates, in the early discovery or development phases, can submit their application to POAI for consideration. Applications for inclusion in the ACE program for Q4 2025 will be accepted starting June 15th, 2025.

Packaging 52

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

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Drug Target Review

JUNE 6, 2025

As antibody-drug conjugates (ADCs) gain traction across oncology and begin to expand into other therapeutic areas, a persistent challenge remains: the design and optimisation of payloads. And we think the package is probably equally, if not more, important.”

Small Molecule 52

Small Molecule Pharmacokinetics Packaging Drugs 52

Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

Packaging 52

Packaging Drugs FDA Pharmaceutical Companies 52

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?

Drugs 68

Drugs FDA Doctors Trials 68

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?

Bioinformatics 76

Bioinformatics Immune Response RNA Packaging 76

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.

Drug Development 52

Drug Development Clinical Trials Disease Drugs 52

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.

Drugs 136

Drugs Small Molecule Bioinformatics Packaging 136

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.

Clinical Research 98

Clinical Research Research Clinical Trials Packaging 98

FDA Law Blog: Biosimilars

MAY 4, 2025

Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro did not store or handle the packages nor maintain records about their contents.

Packaging 52

Packaging Government Regulations International 52

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.

Packaging 98

Packaging Marketing Drugs 98

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

Drugs 96

Drugs Packaging Cell Based Assays Small Molecule 96

FDA Law Blog: Biosimilars

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. In some cases, previously routine postings are delayed or going unpublished altogether.

FDA 59

FDA Packaging Government International 59

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.

Pharmacokinetics 100

Pharmacokinetics Packaging Drugs 100

Drug Target Review

JUNE 2, 2025

Bioconjugates are rapidly emerging as a key frontier in targeted therapies, particularly through Antibody-Drug Conjugates (ADCs) , which combine antibodies with cytotoxic drugs to deliver more precise and effective treatments. The addition of Drug Product assets for cytotoxic substances completes the fully integrated offering.

Small Molecule 52

Small Molecule Engineering Therapies Drugs 52

Drug Patent Watch

MARCH 19, 2025

Navigating the Complex World of Drug Patents: A Comprehensive Strategy is Key As a pharmaceutical professional, you know that developing new medications is a costly and time-consuming process. A well-crafted drug patent strategy can make all the difference in protecting your intellectual property and maintaining market share.

Drugs 40

Drugs Packaging Pharmaceuticals Production 40

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.

Packaging 52

Packaging Drugs Production 52

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.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

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.

Treatment 105

Treatment Packaging Clinical Research Therapies 105

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.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

The Premier Consulting Blog

DECEMBER 10, 2024

Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. Drug product (finished dosage form).

Marketing 52

Marketing Production Compliance Regulations 52

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 Int J Drug Policy. mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively). Published online September 17, 2024.

FDA Approval 52

FDA Approval Pharmacokinetics Packaging FDA 52

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.

Drug Development 92

Drug Development Production Pharmaceutical Companies Clinical Trials 92

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

Engineering 145

Engineering Packaging DNA Treatment 145

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.

Marketing 52

Marketing Packaging Regulations Drugs 52

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.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

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.

Drugs 52

Drugs Packaging Compliance Drug Development 52

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%

Disease 98

Disease Clinical Trials Trials FDA 98

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 .

Research 52

Research FDA Approval Drugs FDA 52

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?

FDA 52

FDA Packaging Production Drugs 52

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.,

Production 52

Production Efficacy & Potency Packaging Drugs 52