PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

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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. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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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. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Animal Testing FDA Drug Development Production 52

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions. ” Scientific Research Publishing , 2024.

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Drug Development Compliance Drugs Regulations 52

Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. Cancer Cell [Internet].

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SugarCone Biotech

JUNE 27, 2025

Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets. ADC: Antibody-Drug Conjugates First it is important to put this wave of drug development into perspective.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. How can you ensure your CDMO is up to scratch?

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Compliance Drug Development Pharma Companies Therapies 52

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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The Premier Consulting Blog

JANUARY 14, 2025

Pediatric and Rare Cancers Pediatric Oncology Program An initiative for development of new products to treat pediatric patients Maximize the authority of the Best Pharmaceuticals for Children Act (BPCA) to increase the number of requests for pediatric studies of new drugs developed for adult cancers much earlier in the development timeline.

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Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. At this point, I knew that I wanted to join the biotech and pharmaceutical industry, so I moved to a small biotech company in London, where I spent three to four years learning the fundamentals of the biotech industry.

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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. These guidelines drive the legitimacy of the models towards regulatory approval.

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The Premier Consulting Blog

AUGUST 21, 2024

Phase-appropriate information and data to support CMC content, such as specifications, analytical methods, analytical method validation, pharmaceutical development, and stability, should be developed as clinical development progresses. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Author Information William E. Spanogle, Ph.D.

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The Pharma Data

NOVEMBER 9, 2020

. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. SOURCE: XPhyto Therapeutics Corp. .

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Pharmaceutical Development Group

DECEMBER 19, 2021

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. In a FDA Pre-Submission that leads to FDA Approval, more does not equal better and more does not equal relevance to a specific Pharmaceutical Drug or Biologic Product.

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The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

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The Pharma Data

JUNE 24, 2025

In this context, the USP’s mAb reference standards offer pharmaceutical manufacturers a critical benchmark. These standards are widely recognized by regulatory agencies such as the FDA and EMA for use in analytical method development, validation, and quality control. Senior Vice President of Global Biologics at USP. Source link

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DS in Pharmatics

FEBRUARY 24, 2023

Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market.

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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? We can offer our readers a special discount for the event.

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Drug Target Review

OCTOBER 31, 2023

Ashley Hall, CDO of Reneo Pharmaceuticals Throughout my education I was discouraged by many around me. How did that transfer into the pharmaceutical industry? This sector of the pharmaceutical industry combined both my science and law background. Every drug has a story: an end game.

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Cell Biology Pharmaceuticals Science Disease 107

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Spanogle, Ph.D.

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FDA FDA Approval Biosimilars Regulations 52

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

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Treatment Licensing Licensing Science 52

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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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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Therapies Treatment Clinical Trials Science 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

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Trials Clinical Trials Drug Development Therapies 69

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

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Clinical Trials Trials Treatment Pharmaceuticals 52

ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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