DrugBank

MARCH 7, 2024

The Quest for Ozempic-Like Alternatives Ozempic, a GLP-1 receptor agonist developed by Novo Nordisk, has demonstrated remarkable efficacy in promoting weight loss and improving metabolic health. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

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DS in Pharmatics

FEBRUARY 24, 2023

Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Specialist regulatory affairs consultants offer services to companies operating across this challenging industry.

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Pharmaceutical Companies Regulations Drug Development Pharmaceuticals 52

FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What?

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Crown Bioscience

MAY 4, 2021

Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e. used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children.

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Research Pharmaceutical Companies Licensing Licensing 52

ACTO

DECEMBER 17, 2024

Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? Such cross-functional collaboration ensures consistent implementation from drug development through commercialization.

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Altus Drug Development

JUNE 28, 2022

Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. Value-added medicines offer an efficient method to meet the needs of patients while stimulating innovation in the pharmaceutical industry. Three main R&D processes are used to develop value-added medicines.

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Pharmaceutical Companies Pharmaceuticals Doctors Treatment 52

Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1.

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H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

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H1 Blog

DECEMBER 11, 2024

Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act. As pharmaceutical companies shift their focus toward fewer, high-value therapeutic areas in light of the IRAs drug price negotiations, the overall number of clinical trials will go down.

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Clinical Trials Trials Pharma Companies Treatment 52

NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

More than 90 percent of that contributory research was basic—that is, related to the discovery of fundamental biological mechanisms, rather than actual development of the drugs themselves. Previous attempts to quantify the contribution of federal funding to new drug development had looked primarily at patents.

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). These designs allow for evaluating multiple drugs or treatments simultaneously, offering a more flexible and efficient approach to drug development.

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Trials Clinical Trials Therapies Treatment 52

Drug Target Review

MAY 23, 2023

The algae-derived non-digestible oligosaccharides can also influence the expression of cytokines that regulate the immune system. 9 Academic scientists researching natural products often struggle with the pitfalls of drug development. Pharmaceutical companies meanwhile need to reinvest in natural product research.

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The Connected Lab

MAY 31, 2022

Now, pharmaceutical industry stakeholders, including technology vendors, are taking the lead to facilitate change. The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors.

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Laboratory Informatics Laboratories Compliance Pharmaceuticals 52

Perficient: Drug Development

AUGUST 20, 2024

For instance, pharmaceutical companies can classify items based on regulatory requirements, ensuring that storage, handling, and documentation are compliant with industry regulations. Item classification helps ensure that items are managed in accordance with these standards.

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Advarra

DECEMBER 14, 2023

b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. One top pharmaceutical company leveraged Advarra’s Longboat intuitive workflow technology to execute these strategies and reduced protocol deviations across their sites by 20%.

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Compliance FDA Clinical Trials Trials 52

DrugBank

FEBRUARY 19, 2025

AI in Clinical Trials - Enhancing Efficiency and Personalization The application of AI in clinical trials has the potential to drastically improve the efficiency of drug development by streamlining the recruitment process and personalizing treatment regimens for individual patients.

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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The Pharma Data

JANUARY 24, 2021

The FTD is designed to make important new drugs accessible to patients faster. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases.

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Agency IQ

FEBRUARY 12, 2024

Per the document’s prologue, the playbook has been intentionally prepared in plain language to “serve AAV drug developers of all backgrounds, but primarily those who could benefit from simplified language, guidelines, and templates for this complex process (e.g., guidance documents) fell short of answering the questions that they had.

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LifeSciVC

OCTOBER 13, 2022

This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Europe – show that regulators are likely open to green-lighting a range of emerging gene therapies.

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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 15, 2020

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. Improved Return on Investment (ROI) Industry-academic partnerships can enhance the financial return on drug development investments.

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Drug Development Clinical Trials Drugs Therapies 98

Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval. The post Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval appeared first on Advarra.

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Drug Development Disease Therapies Engineering 52

Drug Target Review

JANUARY 5, 2024

Scientists from the Centre for Genomic Regulation and the Wellcome Sanger Institute have found the allosteric control sites in the KRAS protein, the highly sought after targets for drug development. For the purposes of drug discovery, it’s like turning the lights on and laying bare the many ways we can control a protein.”

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DrugBank

FEBRUARY 26, 2025

In response, researchers and pharmaceutical companies are exploring novel approaches to antibiotic development. The Growing Threat of Antibiotic Resistance Antibiotic resistance occurs when bacteria evolve mechanisms to evade the effects of drugs designed to kill them.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

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Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. for non-viral cell immunotherapeutic drug development.

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DrugBank

DECEMBER 4, 2024

The high cost of drug development , estimated to be over $4.54 billion per new drug to the German Cancer Research Center, is a significant barrier to access, particularly for LMIC with limited resources.    Pricing policies and healthcare financing mechanisms are crucial in determining drug access.

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Drug Patent Watch

JANUARY 14, 2025

.”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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Drug Development Drugs FDA Production 76

Codon

APRIL 24, 2025

While China’s AI competitiveness may have blindsided the tech world, the pharmaceutical industry has already had quite a few “ DeepSeek Moments ” of its own. About one-fourth of all clinical trials and early drug development now happens in China. regulators hoping to speed up drug development, too.

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Clinical Trials Trials Pharmaceutical Companies Licensing 100

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. By partnering with a CDMO, companies can benefit from these resources without having to invest in their own infrastructure.

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Drug Patent Watch

DECEMBER 19, 2024

As companies invest billions in research and development, protecting their innovations through strategic patent management has become more important than ever. This comprehensive guide will explore how pharmaceutical companies can leverage their drug patent portfolios to maximize value, maintain market dominance, and drive innovation.

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