Drug Target Review

APRIL 30, 2025

Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. Faster time-to-market and reduced costs. The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT.

Drugs 90

Drugs Therapies Clinical Trials Trials 90

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.,

Therapies 40

Therapies Licensing Licensing Treatment 40

SugarCone Biotech

JUNE 19, 2025

Amgen’s clinical development studies of tarlatamab include the DeLLphi-305 trial in ES-SCLC testing a first-line maintenance regimen following durvalumab plus chemo (Amgen markets the anti-PD-L1 checkpoint inhibitor durvalumab). The tarlatamab results have of course triggered a stampede of development of DLL3-targeted therapies.

Therapies 78

Therapies Clinical Trials Treatment Clinical Development 78

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

Clinical Development 52

Clinical Development International Drug Development Clinical Research 52

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. It’s equally important to communicate your long-term plans.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. Failure to meet these standards can result in delays, rejection, or even post-market withdrawal if safety concerns arise later.

Drug Development 52

Drug Development Clinical Trials Compliance Drugs 52

Conversations in Drug Development Trends

JULY 3, 2025

Surveillance mechanisms for innovative, but not yet approved therapies, may change to accelerate clinical development. As the industry continues to grow, we can expect further regulatory streamlining for emerging CGT modalities, based upon a more granular and expansive clinical database extracted from real-world experience.

Therapies 40

Therapies Regulations Clinical Trials FDA 40

DrugBank

JULY 14, 2025

The complexity of pharmacokinetics and pharmacodynamics, coupled with the variability in patient populations, makes predicting and managing DDI a particularly challenging aspect of drug development.  These models simulate drug interactions based on their molecular properties, metabolic pathways, and transport mechanisms.

Clinical Development 52

Clinical Development Pharmacokinetics Drugs Clinical Trials 52

SugarCone Biotech

JULY 6, 2025

It follows that HER3-targeting therapies have emerged as a class of anti-cancer treatments designed to treat various tumors that have developed resistance to EGFR or HER2-directed therapies or have emerged due to a NRG1 gene fusion. This is an active drug development landscape with a lot of recent news.

Drug Development 56

Drug Development Drugs Clinical Trials Therapies 56

BioPharma Drive: Drug Pricing

JUNE 11, 2025

In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million. billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immune drug developer since April 2023.

FDA 270

FDA Drugs Therapies Science 270

Drug Target Review

MAY 26, 2025

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. Almost without exception, CROs are involved in the development of novel therapies.

Drug Development 52

Drug Development Drugs Therapies Pharmaceuticals 52

Drug Target Review

MAY 5, 2025

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinical development strategies that promote agility, efficiency and effectiveness.

Clinical Development 52

Clinical Development Drug Development Therapies Science 52

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. Until Vykat came along, though, no drug therapies were specifically approved to curb the all-consuming hunger that hallmarks the condition.

Drugs 221

Drugs Licensing Licensing Therapies 221

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application. All the while, this efficiency in clinical development requires accelerating CMC by having early-stage studies serve as large stage studies.

Therapies 59

Therapies FDA Production Disease 59

Conversations in Drug Development Trends

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan?

Clinical Trials 52

Clinical Trials Drug Development FDA Trials 52

BioPharma Drive: Drug Pricing

NOVEMBER 4, 2024

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

Production 205

Production Clinical Development Drug Development Marketing 205

PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

Clinical Development 98

Clinical Development Clinical Trials Clinical Research Drug Development 98

Fierce BioTech

OCTOBER 21, 2024

Carl Sailer is Vice President of Full Service Solutions at Syneos Health®, a leading fully integrated biopharmaceutical solutions organization providing clinical development and commercialization s | In this conversation with Fierce Biotech, we explore the ever-evolving biotech landscape.

Marketing 98

Marketing Clinical Development Drug Development Drugs 98

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

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. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture. At Worldwide, we understand that every program is different, which means every drug development path forward will be unique.

Clinical Trials 136

Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

Clinical Development 52

Clinical Development Pharmaceuticals Clinical Trials Trials 52

PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

Clinical Development 52

Clinical Development Clinical Trials Trials Drug Development 52

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment Drugs FDA Approval 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

FDA 96

FDA Trials Clinical Trials Disease 96

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products. The balance is complex, as obesity carries its own serious health risks.

Treatment 130

Treatment Drugs Therapies FDA 130

Cytel

JUNE 20, 2023

How might this affect pediatric drug development? However, two new draft guidelines have now been published, including policy changes that may affect current opportunities for pediatric exclusivity and when data may be extrapolated from adults.

FDA 52

FDA Marketing Drug Development Drugs 52

LifeSciVC

OCTOBER 18, 2023

By Bob Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC As we enter the final leg of 2023, navigating the investment market in biotech continues to be fraught with twists and turns. Where are investments going in the current market? This type of approach can certainly yield winners.

Clinical Development 73

Clinical Development Marketing Clinical Trials Production 73

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions. Japan, and China.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

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. Figure 2 shows pipelines across modalities for some of the competitive targets today.

Small Molecule 143

Small Molecule Trials Therapies Disease 143

Conversations in Drug Development Trends

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

Cytel

FEBRUARY 14, 2024

During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common mistakes drug developers make that can be avoided if they consider their regulatory strategy and adapt it over time.

Drug Development 59

Drug Development Marketing Drugs Clinical Development 59