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.

Biosimilars 97

Biosimilars Clinical Trials Immune Response Trials 97

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.

Therapies 260

Therapies Clinical Trials Trials Production 260

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.

Clinical Trials 243

Clinical Trials Trials Production 243

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.

Clinical Trials 264

Clinical Trials Trials Production 264

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.

Production 128

Production Drugs Small Molecule Bioinformatics 128

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.

Production 117

Production Small Molecule Regulations Trials 117

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.

Clinical Trials 105

Clinical Trials Biosimilars Trials Treatment 105

PPD

JULY 6, 2023

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

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.

Production 104

Production Government Trials Marketing 104

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.

Therapies 72

Therapies Clinical Supply Clinical Trials Trials 72

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.

FDA Approval 130

FDA Approval Trials FDA Production 130

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.

Licensing 96

Licensing Licensing Drugs Clinical Trials 96

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.

Trials 173

Trials Production Drugs 173

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.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

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.

Trials 98

Trials Clinical Trials Clinical Development Clinical Research 98

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.

Small Molecule 123

Small Molecule Engineering Production DNA 123

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.

Drugs 97

Drugs Drug Development Pharmaceuticals Production 97

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?

Trials 78

Trials Disease Drug Development Clinical Trials 78

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.

Therapies 64

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.

Clinical Trials 96

Clinical Trials Regulations Trials Clinical Research 96

PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

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.

Clinical Trials 105

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.

Trials 80

Trials Clinical Trials Regulations FDA 80

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Any delays or missteps in bioanalysis during a Phase I trial can derail the trajectory of a promising drug.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

H1 Blog

NOVEMBER 21, 2023

AI has the potential to revolutionize drug discovery, clinical trials, and personalized medicine. However, before integrating an AI product into a life sciences workflow , it is crucial to evaluate its effectiveness and reliability rigorously. Improve clinical trial predictions? Or perhaps optimize patient diagnosis?

Science 64

Science Production Clinical Trials Regulations 64

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

Therapies 98

Therapies Trials FDA Clinical Trials 98

Drug Patent Watch

DECEMBER 30, 2024

Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. Challenges and Opportunities Ethnic Bridging : Japan has historically required clinical trials to be conducted within the country to account for ethnic differences.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Listing Image DrVince_ListingLogo_250x190.png

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

Cytel

MARCH 11, 2024

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. A primary challenge arises from the small populations from which clinical trial participants can be recruited, and from often limited prior knowledge on a disease.

Clinical Trials 59

Clinical Trials Trials Disease Clinical Development 59

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

Treatment 68

Treatment Trials Clinical Trials Drugs 68

Agency IQ

JULY 22, 2024

BY AMANDA CONTI In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Clinical Trials 59

Clinical Trials Trials Drugs FDA 59

FDA Law Blog: Drug Discovery

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

Clinical Trials 64

Clinical Trials Trials FDA Drug Development 64

Vial

MAY 13, 2024

However, progress from molecule to approved drug is hampered by extremely high costs and lengthy clinical trials , and approximately 90% of drugs that reach clinical trials fail. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 An estimated 80% of clinical trials do not finish on time.

Clinical Trials 52

Clinical Trials Trials Drug Development Production 52

The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52

Trials FDA Clinical Trials Disease 52

Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. Outdated systems: Many organizations rely on legacy data management tools that fail to meet the demands of modern clinical trials.

Clinical Trials 52

Clinical Trials Trials Science Production 52

Codon

JULY 14, 2024

receives a blood transfusion or a blood product every two seconds. But currently, traditional blood transfusions face significant challenges, including a dwindling pool of donors and a limited shelf life for stored blood products. However, the subsequent death of another patient thrust Denys into a contentious trial.

Production 140

Production Clinical Trials Trials Therapies 140