Drug Patent Watch

DECEMBER 9, 2024

This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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Biosimilars Clinical Trials Immune Response Trials 92

BioPharma Drive: Drug Pricing

APRIL 29, 2024

Applying a systems thinking framework to clinical trial design prompts purposeful and productive collaboration among stakeholders.

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Clinical Trials Trials Production 141

Drugs.com

FEBRUARY 29, 2024

29, 2024 -- Folks hoping to quell their anxiety would do best to use cannabis products that don’t get them high, a new clinical trial has found.The non-intoxicating marijuana compound CBD appears to help manage anxiety better than. THURSDAY, Feb.

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Drugs.com

JUNE 25, 2024

TUESDAY, June 25, 2024 -- An experimental stem cell therapy can essentially cure type 1 diabetes by restoring insulin production in some patients, early clinical trial results show.Seven out of 12 patients no longer needed daily insulin shots after.

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LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. In order to start building a case for or against a target, I like to start with genetics – first human and then mouse.

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Production Small Molecule Regulations Trials 133

Drugs.com

MAY 29, 2024

WEDNESDAY, May 29, 2024 -- Feeding kids peanuts early in childhood can drastically reduce their risk of developing a peanut allergy, a new clinical trial reports.Children regularly fed peanut products from infancy to age 5 had a 71% lower rate of.

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Clinical Trials Trials Production 243

Drug Target Review

MARCH 28, 2024

Between 2000 and 2020, approximately 30 percent of the newly introduced small molecule drugs were derived from natural products. In recent decades there has been a decline in interest in natural products for drug discovery, with the industry gravitating towards screening libraries of synthetic molecules with predefined chemistries.

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Production Drugs Small Molecule Bioinformatics 128

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Biosimilars Trials Clinical Trials Production 56

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.

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Drugs Clinical Development Therapies Clinical Trials 130

The Pharma Data

JUNE 25, 2025

Biogen Reports Promising Interim Phase 1 Results for Salanersen in Spinal Muscular Atrophy, Prepares for Registrational Trials Biogen has announced encouraging topline results from its Phase 1 clinical trial evaluating salanersen (BIIB115/ION306) , an investigational antisense oligonucleotide (ASO) therapy for spinal muscular atrophy (SMA).

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Therapies Trials RNA Treatment 52

ProRelix Research

JULY 6, 2023

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases.

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Clinical Trials Biosimilars Trials Treatment 105

Drug Target Review

APRIL 30, 2025

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?

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Drugs Therapies Clinical Trials Trials 90

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. clinical operations, pharmacovigilance, regulatory) across various medicinal products, a portfolio of studies or the entire company.

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Clinical Development Clinical Trials Trials Regulations 98

Drug Target Review

JUNE 9, 2025

To do this, Alltrna leverages the unique biology of tRNA and its AI-enabled platform to design engineered tRNAs that can restore full-length protein production in diseases caused by shared genetic mutations, such as premature termination codons. While commonly used in oncology, the basket trial approach is novel for rare genetic diseases.

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Disease Treatment Engineering Protein Production 80

The Pharma Data

JULY 2, 2025

Biogen Launches Global Phase 3 PROMINENT Trial Evaluating Felzartamab in Primary Membranous Nephropathy Biogen Inc. The trial is expected to complete in 2029. In the M-PLACE trial, participants showed a median 45% reduction in aPLA2R titers within one week of treatment, with over half showing significant responses by six months.

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Trials Disease FDA Approval Treatment 40

Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Therapies Clinical Supply Clinical Trials Trials 72

FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. By Riëtte van Laack & Anne K. What led to this conviction? It is a long story that started more than a decade ago.

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Production Government Trials Marketing 104

BioPharma Drive: Drug Pricing

DECEMBER 16, 2024

Novo Nordisk is investing more than $1 billion in a new production facility in Denmark. Elsewhere, drugs from Neurocrine Biosciences, Checkpoint and Galderma won new FDA approvals.

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FDA Approval Trials FDA Production 130

Codon

FEBRUARY 13, 2025

Traditionally, scientists discover enzymes in nature and adapt them through trial and error. The enzyme must not only bind substrates correctly but also maintain stability through each transformation while handling intermediate products without inhibition. Despite recent advances in AI, doing so remains a formidable challenge.

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Small Molecule Engineering Production DNA 138

Advarra

DECEMBER 17, 2024

These companies are laying the groundwork for more sophisticated AI applications designed to transform clinical operations, improving both efficiency and productivity. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

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Clinical Research Clinical Trials Trials Hospitals 98

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

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Clinical Development Clinical Trials Clinical Pharmacology Trials 69

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

BioPharma Drive: Drug Pricing

DECEMBER 20, 2023

The Dutch biotech’s star product has lost some luster after a second failed Phase 3 trial in two months, this time for a skin condition called pemphigus.

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Trials Production Drugs 169

The Pharma Data

JUNE 6, 2025

has announced encouraging interim findings from the pivotal Phase 3 VISIONARY trial evaluating sibeprenlimab in adults with Immunoglobulin A nephropathy (IgAN), a rare and progressive autoimmune kidney disorder. We are grateful to the patients who have contributed to advancing the science through their participation in this landmark trial.”

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Trials Treatment Therapies FDA 40

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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Licensing Licensing Drugs Biosimilars 89

PPD

OCTOBER 8, 2024

With FSO, all clinical trial tasks (e.g., across protocols, medicinal products, a portfolio of studies or the entire company. In a hybrid model, one or more FSP offerings are added to a new or existing FSO arrangement to optimize clinical trial operations or address unforeseen circumstances and changing demands.

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Trials Clinical Trials Clinical Development Clinical Research 98

The Pharma Data

JUNE 11, 2025

Ionis Begins Pivotal Phase 3 REVEAL Study of ION582 in Angelman Syndrome, Dosing First Patient in Global Trial Ionis Pharmaceuticals , Inc. This trial will build on previous positive data from the earlier Phase 1/2 HALOS study and is designed to rigorously assess the potential of ION582 as a disease-modifying therapy. “We

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Trials Therapies Treatment Disease 40

Fierce BioTech

APRIL 17, 2025

This panel discussion will address how to achieve tangible productivity gains, accelerate timelines, and avoid costly protocol amendments or clinical failures using Advanced technologies (e.g., Click here to login.

Clinical Trials 52

Clinical Trials Production Trials Science 52

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Trials Disease Drug Development Clinical Trials 78

Drug Patent Watch

DECEMBER 9, 2024

High-Throughput Screening: Modern Technology Meets Natural Products Advanced technologies now allow researchers to rapidly test thousands of natural compounds against specific disease targets. The development of Taxol involved multiple patents, including those for the isolation method, synthetic production, and various formulations.

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Drugs Drug Development Pharmaceuticals Production 94

ProRelix Research

MAY 10, 2025

With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever. Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research.

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Clinical Trials Compliance Regulations Trials 52

New Drug Approvals

APRIL 11, 2025

2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] Fitusiran 1711.0g/mol,

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Clinical Trials FDA FDA Approval Trials 107

Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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Therapies Treatment Engineering Clinical Trials 64

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.

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Clinical Trials Regulations Trials Clinical Research 96

Drug Target Review

JUNE 6, 2025

“Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.” Prior treatments and patient histories often introduce variables that can affect outcomes, making thoughtful trial design essential for generating reliable data.

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Therapies Treatment Drug Development Clinical Development 100

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80