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. My focus has always been on advancing novel medicines from research to clinical development.

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PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

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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. In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen.

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Drug Target Review

JUNE 11, 2025

Clinical genomics, powered by NGS, enables more precise target validation, improved patient stratification and optimised trial design, ultimately aiming to increase PoS. For example, MLMs can simultaneously explore genetic sequences and clinical data to improve crucial characteristics such as efficacy, safety and bioavailability.

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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.

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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.

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The Pharma Data

JUNE 13, 2025

Director of Lymphoma Research at Sarah Cannon Research Institute and principal study investigator for the trial. Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. “As formerly Cellular Biomedicine Group, Inc.). formerly Cellular Biomedicine Group, Inc.).

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The Pharma Data

JUNE 25, 2025

It provides a range of incentives to the sponsoring company, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, fee waivers, and eligibility for expedited regulatory pathways. The financial and strategic implications of such a designation are not limited to market exclusivity.

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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

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The Pharma Data

JUNE 24, 2025

This significant financial infusion is designed to fuel Revolution Medicines’ ambitious clinical development and commercialization plans, with a particular focus on its groundbreaking RAS(ON) inhibitor programs for patients with RAS-addicted cancers. This aligns both parties’ interests toward long-term success in the market.

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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.

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Conversations in Drug Development Trends

JULY 3, 2025

The CRO Perspective From a Contract Research Organization (CRO) specializing in the design and execution of studies for innovative therapies, the REMS requirements have significantly complicated the design and execution of CAR T clinical trials.

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The Pharma Data

JUNE 24, 2025

This expanded partnership reflects Bayer’s ongoing commitment to strengthening its presence in China—home to the world’s second-largest pharmaceutical market—and underscores its strategic vision to bolster healthcare innovation through cross-sector collaboration.

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The Pharma Data

JUNE 6, 2025

Rilzabrutinib: A Potentially Transformative Therapy in ITP Among the most anticipated presentations is new data from the LUNA 3 phase 3 clinical trial evaluating rilzabrutinib, an investigational, reversible, oral BTK inhibitor, in adults with immune thrombocytopenia (ITP). In the U.S.,

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DrugBank

JUNE 18, 2025

Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

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The Pharma Data

JUNE 22, 2025

Exelixis Reports Positive Phase 3 Results for Zanzalintinib and Atezolizumab Combo in Metastatic Colorectal Cancer Exelixis , has announced promising topline results from the STELLAR-303 phase 3 pivotal clinical trial, a major milestone in the development of its investigational therapy zanzalintinib.

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DrugBank

JULY 14, 2025

Drug-drug interactions (DDI) are a significant concern in clinical trials, where the safe and effective administration of drugs to patients is crucial.   Challenges in Managing Drug-Drug Interactions in Clinical Development Predicting and managing DDI in clinical trials is one of the most complex challenges in drug development.

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BioPharma Drive: Drug Pricing

JUNE 11, 2025

Ibtrozi was approved based on a pair of trials showing response rates of 90% and 85%, respectively, in patients who hadn’t previously received another tyrosine kinase inhibitor. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials.

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SugarCone Biotech

JULY 6, 2025

Of course the larger markets would be in non-NRG1 fusion cancers where HER3 is overrexpressed but Partner Therapeutics does not appear to be supporting additional clinical trials. This is where the rest of the drug development field comes in. This will lead to near-term approval in NPC.

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The Pharma Data

JUNE 20, 2025

Groundbreaking Data from the Phase III ARANOTE Trial The CHMP’s recommendation is founded on data from the pivotal Phase III ARANOTE clinical trial, which demonstrated that darolutamide, when used in combination with ADT, significantly reduced the risk of radiological progression or death in patients with mHSPC.

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The Pharma Data

JUNE 13, 2025

The approval is supported by data from KEYNOTE-689, a pivotal Phase 3 trial that evaluated KEYTRUDA in this patient population. Based on these trial results, KEYTRUDA as a key component of this regimen shows tremendous potential to enable patients to live longer without disease recurrence and hopefully improve their overall prognosis.”

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New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).

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The Pharma Data

JUNE 19, 2025

Grifols’ BT524 Fibrinogen Therapy Shows Promise in Phase 3 Trial Published in The Lancet’s eClinicalMedicine Grifols , a globally recognized healthcare company and a leader in the production of plasma-derived therapies, has marked a significant advancement in the treatment of acquired fibrinogen deficiency (AFD).

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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. This global role allowed him to develop the application of innovative technologies to bring new ATMPs to the clinic.

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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.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Spencer Platt via Getty Images The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5

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LifeSciVC

JULY 10, 2025

And that’s not necessarily a bad thing – private biotech companies are increasingly taking programs later in clinical development, and that inherently requires larger raises to fund through important milestones. keeping all experiments, discovery campaigns, clinical trials, etc. Is something not resonating?

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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. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations.

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Drug Patent Watch

JANUARY 8, 2025

With billions of dollars invested in research and development, protecting your intellectual property is not just importantit’s essential. This comprehensive guide will walk you through the intricacies of optimizing your drug patent strategy, ensuring that your innovations are safeguarded and your market position is strengthened.

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The Pharma Data

JULY 3, 2025

This support will accelerate the clinical development of the company’s pioneering DUO™ System—a minimally invasive transcatheter device designed to treat severe cases of tricuspid regurgitation. These attributes are expected to make the therapy more accessible in routine clinical practice. CroíValve Awarded €12.5M

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ProRelix Research

APRIL 29, 2025

Gain insights into key strategies for clinical validation in the probiotics industry that uphold scientific rigor while driving market growth and consumer confidence.

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Conversations in Drug Development Trends

MAY 15, 2025

Have you considered the multiple associated benefits and implications in the context of your novel drug development plan? This blog highlights some of the key themes discussed in our white paper on the application process, From Concept to Market: The Strategic Role of an IND in Drug DevelopmentMoving Beyond “May Proceed.”

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BioPharma Drive: Drug Pricing

FEBRUARY 24, 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

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PPD

SEPTEMBER 16, 2024

Real-world data paired with machine learning is a game changer in drug development RWD is becoming increasingly important in influencing the drug development landscape, particularly when used to develop the natural history and patient journey through disease. AI has the potential to disrupt the entire clinical trial process.

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Cytel

JANUARY 15, 2024

After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinical development has felt this slowdown, but as we begin 2024, there is reason for optimism.

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PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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