FDA Law Blog: Drug Discovery

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

FDA

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

Drug Development

Drug Target Review

JULY 21, 2025

The global market for CNS therapeutics was worth an estimated $144.3 However, the advanced nature of the drugs being developed has brought new challenges. However, the advanced nature of the drugs being developed has brought new challenges. million last year and is expected to grow to $410 million by 2035.

Drug Development

Drug Patent Watch

DECEMBER 9, 2024

This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents? This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?

Drugs

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.

Clinical Development

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.

Drugs

Drug Target Review

JUNE 9, 2025

A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drug development at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.

Disease

The Pharma Data

JULY 2, 2025

Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan.

Trials

PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development

PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.

Drug Development

FDA Law Blog: Biosimilars

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). As a single-arm trial (i.e., Join us as we break down what went wrong this time. The problem?

Drugs

The Pharma Data

JUNE 27, 2025

The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. It is marketed under the brand name Fintepla® and has shown considerable success in significantly reducing seizure frequency while improving quality of life in these populations.

Trials

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinical trials become more complex, and the importance of robust financial oversight has never been clearer.

Clinical Trials

The Premier Consulting Blog

DECEMBER 10, 2024

Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. Drug product (finished dosage form).

Marketing

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. His experience has played a key role in shaping a more capital-efficient model for bringing cell therapies to market.

Therapies

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. Conventional models often fail to predict cardiac side effects, especially with biologics.

Drug Research

The Pharma Data

JUNE 9, 2025

Food and Drug Administration (FDA) as a monotherapy for children with achondroplasia. TransCon hGH , marketed as SKYTROFA® for pediatric growth hormone deficiency, is a once-weekly prodrug of somatropin (human growth hormone). The Week 26 data from the COACH Trial now show that TransCon hGH may further enhance these benefits.

Trials

The Pharma Data

JUNE 25, 2025

As of the closing of the transaction, all shares of Regulus common stock, previously traded on the Nasdaq Stock Market under the ticker symbol RGLS, have been delisted. The drug’s mechanism also aims to delay the overall progression of disease severity—an urgent need in a patient population that often progresses to end-stage renal disease.

RNA

Drug Target Review

JUNE 19, 2025

In the field of drug discovery, few areas face a more pressing need for innovation than pain management. Instead, Bazan explains that the drug modulates genes involved in mechanical nociception – the body’s process of detecting harmful or painful stimuli such as pressure or injury – giving it a unique pain-relieving profile.

Clinical Trials

The Pharma Data

JUNE 24, 2025

The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.

Drug Development

Drug Target Review

APRIL 7, 2025

The challenge of GPCR drug discovery G protein-coupled receptors (GPCRs) are one of the most desirable and challenging target classes in drug discovery, as their mutation can lead to a wide range of diseases such as cancer, cardiovascular disorders and neurological conditions.

Fragment Screening

The Pharma Data

JUNE 26, 2025

Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinical development program to evaluate MR-141 for presbyopia. The trial was conducted as a randomized, placebo-controlled, double-blind study and enrolled a total of 545 adult participants.

Trials

Alta Sciences

JUNE 6, 2025

For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. My experience as an optimization scientist has shown how automation can be a valuable tool to support drug development for sponsors of all sizes.

Pharmacokinetics

BioPharma Drive: Drug Pricing

JULY 8, 2025

Unlike most approved drugs, which work by turning cell signaling up or down like a dimmer switch, this approach aims to rid cells of problem proteins entirely. Earlier this year, the field got its best look yet at how well one common type of these drugs performs. Several have drugs in or near clinical testing.

Targeted Protein Degradation

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. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

Clinical Trials

Drug Target Review

NOVEMBER 25, 2024

Her journey in drug R&D and business development has been marked by significant achievements, including leading groundbreaking efforts to treat neglected cancers and breaking barriers for women in the biotech industry. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.

Treatment

The Pharma Data

JUNE 25, 2025

FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

FDA

Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. I have spent the better part of my career working to make drugs safer. corticosteroids, beta-blockers, antidepressants).

Clinical Trials

PPD

JULY 29, 2025

Biopharma and biotech industries are facing remarkable challenges as the cost of developing new drugs has surged dramatically and clinical trial timelines have extended significantly. For example, over the past decade, the average time required to complete a clinical trial has increased by approximately 20-30%.

Clinical Trials

SugarCone Biotech

JUNE 19, 2025

Two large and randomized clinical trials, IMpower-133 and CASPIAN, showing statistically significant improvements in outcomes when chemotherapy was combined with atezolizumab or durvalumab, respectively, in the first-line treatment of ES-SCLC. This Phase 3 trial compared tarlatamab with chemotherapy as second-line treatment.

Therapies

Drug Patent Watch

JUNE 13, 2025

According to our analysis of clinical trial listings, the following industries are leading the charge in seeking legal counsel: Biotech: With a 25% increase in clinical trial listings over the past year, biotech companies are racing to secure patents and protect their intellectual property.

Clinical Trials

New Drug Approvals

JULY 9, 2025

5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6] 7] Efficacy was evaluated in WU-KONG1B (NCT03974022), a multinational, open-label, dose randomization trial. [1] Food and Drug Administration (FDA). 2 July 2025. CD-21-1615. .

FDA

The Pharma Data

JUNE 13, 2025

Mitsubishi Research Institute and Astellas Forge Collaborative Initiative to Support Japanese Drug Discovery Startups and Boost Global Innovation Mitsubishi Research Institute, Inc. The main objective of MEDISO is to aid Japanese drug-discovery ventures in navigating the complex path toward commercial readiness.

Research

Conversations in Drug Development Trends

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

Research

Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

Drug Development

The Pharma Data

JUNE 18, 2025

The company’s lead candidate, NCX-L2 , is specifically designed to slow or even halt the progression of Parkinson’s disease—a neurodegenerative condition that currently has no disease-modifying therapies on the market.

Therapies

Fierce BioTech

JUNE 27, 2025

The ABC of ADCs: Technical, Regulatory & Clinical Insights Antibody-drug conjugates (ADCs) are revolutionizing oncology, but developing them is complex. Download this whitepaper for expert strategies to streamline development and accelerate your path to market.

Clinical Trials