Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

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PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. LEARN HOW The post How to Optimize Drug Development by Combining FSO and FSP Models appeared first on PPD Inc.

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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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The Premier Consulting Blog

JANUARY 14, 2025

Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific expertise to accelerate the review and approval of drugs, biologics, and medical devices for cancer care. These reviews have provided life-saving cancer therapies a median of 3.1

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Starting with the right internal standard Selecting the appropriate internal standard (IS) is vital in toxicology, as inaccuracies could obscure toxic metabolites and lead to flawed safety evaluations.

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The Pharma Data

JUNE 16, 2025

Teva and Fosun Pharma Forge Strategic Partnership to Develop and Commercialize Innovative Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology Teva Pharmaceutical Industries Ltd. This collaboration marks a significant step forward in global oncology drug development. and Shanghai Fosun Pharmaceutical (Group) Co.,

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Drug Target Review

JUNE 5, 2025

Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.

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The Pharma Data

JUNE 18, 2025

Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D., He holds a B.A.

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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. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

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Drug Target Review

OCTOBER 30, 2024

As we continue to evolve our drug characterisation processes at Verseon, we see the extensive use of assembloids as essential enabling technology for the future of all drug development. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery. Cell Stem Cell. 2013;13(6):734-44.

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Drug Target Review

JANUARY 14, 2025

Nina Truter Nina Truter is a translational scientist with a deep focus on understanding mechanisms of action in drug development and leveraging disparate datasets in biotech.

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Drug Target Review

DECEMBER 6, 2024

For more: [link] ; [link] ; [link] ; [link] Nina Truter Nina Truter is a translational scientist with a deep focus on understanding mechanisms of action in drug development and leveraging disparate datasets in biotech.

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The Pharma Data

JUNE 27, 2025

These data offer new hope to the CDD community, which has long struggled with a lack of effective seizure control therapies. The lack of approved therapies specifically indicated for CDD means that treatment strategies are often based on off-label use of anti-seizure medications, with limited success.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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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. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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PPD

JUNE 7, 2023

The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.

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PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required.

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LifeSciVC

APRIL 17, 2025

However, there are times when refusing to stop and re-evaluate is to our disadvantage, especially if our (and our teams) bandwidth can be better spent pursuing other potential therapies. Does the data (internal or external) tell you something different about your program or platform than your ingoing assumption?

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New Drug Approvals

APRIL 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. under nitrogen. PMID 39775738.

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DrugBank

MAY 15, 2024

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

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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.” Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S. ” Prof.

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PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

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DrugBank

JANUARY 15, 2025

Characterized by small patient populations, high development costs, and complex regulatory pathways, these therapies navigate a landscape distinct from blockbuster drugs targeting common diseases.   The Orphan Drug Paradox Orphan drug development is often described as a "high-risk, high-reward" endeavor.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

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The Pharma Data

JUNE 6, 2025

Instead, it has become a strategic asset for pharmaceutical and biotechnology firms seeking to enhance commercial execution while managing internal resource limitations and regulatory complexity. Equally important is regulatory compliance. This capability gives clients peace of mind and reduces legal risk in sensitive therapeutic areas.

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The Pharma Data

JUNE 26, 2025

This international recognition marks a significant milestone for WuXi AppTec, highlighting the company’s dedication to not only advancing science and technology but also to fostering innovative, human-centric work environments that support its mission of enabling global healthcare innovation.

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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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Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

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The Pharma Data

OCTOBER 9, 2021

Neumora leverages proprietary multimodal capabilities and technologies to integrate advanced computational data science with R&D to increase the probability of success of drug development in brain diseases. executive vice president of Research and Development at Amgen. Reese, M.D.,

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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Drug Target Review

OCTOBER 31, 2023

Given there were no other drugs available to them, I cannot even describe the urgency I felt when I entered the project on the drug development side. The drug ended up getting approved, and it extended the lives of children many years where they previously would have had four months at best.

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Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK.

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Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

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