PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

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Drug Target Review

APRIL 7, 2025

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.

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Drug Target Review

DECEMBER 20, 2024

These innovations have started to shift industry perceptions, positioning AI as a transformative tool that could alter how drugs are developed, tested, and brought to market. By increasing the chances that more participants will receive the treatment being tested, recruitment becomes more efficient, speeding up the overall trial process.

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Drug Target Review

JANUARY 4, 2024

What distinguishes Alder Therapeutics’ approach to regenerative cell therapy development from traditional methods, and how does it aim to reduce risks in the preclinical phase? Traditional approaches to regenerative cell therapy development are defined by several challenges. For manufacturing, it’s no different.

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ASPET

OCTOBER 20, 2023

However, Pramlintide an adjunct to insulin therapy, enhances glucagon suppression and thereby offers improved glycaemic control. Although clinical benefits of Pramlintide are well reported, there still exists a high patient resistance for the therapy as separate injections for Pramlintide and insulin are required to be administered.

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Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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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. This limited pool poses significant barriers to conducting statistically significant studies and validating the efficacy and safety of new treatments.

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Drug Target Review

AUGUST 29, 2024

What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies? MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs.

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Drug Target Review

AUGUST 6, 2024

Autoimmune diseases : Rheumatoid Arthritis : ADCs targeting specific immune cells or inflammatory mediators can provide more precise treatment options with potentially fewer side effects. Obesity : By targeting adipose tissue or specific metabolic pathways, ADCs could offer new treatments for obesity and related metabolic disorders.

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Drug Patent Watch

DECEMBER 9, 2024

From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Taxol: From Pacific Yew to Cancer Treatment Taxol (paclitaxel), a widely used cancer drug, was originally isolated from the bark of the Pacific yew tree.

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Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. Could you give us an overview of the Lineage platform?

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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ASPET

SEPTEMBER 7, 2023

Alglucosidase alfa, a recombinant human acid α-glucosidase, was the first approved treatment for Pompe disease, but its uptake into skeletal muscle via the cation-independent mannose-6-phosphate (M6P) receptor (CIMPR) is limited. These results further substantiate the crucial role of CIMPR binding in lysosomal targeting of ERTs.

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Fierce BioTech

MARCH 6, 2025

AI-powered digital phenotyping and real-world data (RWD) offer new ways to locate overlooked patient populations, identify gaps between clinical guidelines and real-world treatment patterns, and optimize market positioning and messaging.

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ASPET

OCTOBER 12, 2023

The focus of the CET RAIDR effort is to bridge treatment gaps between threat identification and the implementation of licensed targeted MCMs, thereby strengthening warfighter resiliency. The CET RAIDR program conserves both time-to-market and funds by leveraging previous conventional development work as a launch point for repurposing efforts.

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Quanticate

NOVEMBER 21, 2024

An efficacy endpoint in oncology is a characteristic or variable that measures how beneficial a treatment is to a patient’s feeling, function, and survival in a clinical trial. They are essential for assessing whether new cancer therapies are safe and efficacious [1].

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. Nearly 39% of sponsors cite these costs as primarily driven by complex protocols.

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DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Antidote

JANUARY 3, 2023

Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

NC: I think the continued growth in cell and gene therapy research and the approvals we’re seeing for genetically-driven rare diseases. What emerging technologies or therapies are you most excited about for 2025, and how do you think they will impact rare disease treatments? DA: Several things!

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DS in Pharmatics

JUNE 10, 2023

On April 12, 2023, BeNeLuxA1 announced that negotiations failed to secure reimbursement for Libmeldy, a gene therapy developed by Orchard Therapeutics for the treatment of metachromatic leukodystrophy, on grounds of price. In the UK, an initial application to NICE was rejected as well back in 2020. This is a huge […]

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The Pharma Data

SEPTEMBER 10, 2021

– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. This is the first marketing authorization globally for abrocitinib-.

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The Pharma Data

JUNE 22, 2023

Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan SANTA MONICA, Calif.–(BUSINESS in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta ®. to Gilead Sciences K.K.,

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The Premier Consulting Blog

NOVEMBER 6, 2024

Inhaled combination products (ICP) have emerged as a significant advancement in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary conditions. What regulatory division governs ICPs? ICPs are subject to rigorous regulatory scrutiny due to their complexity.

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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.

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DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

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DrugBank

MARCH 15, 2024

The weight loss industry has emerged as a major hub for innovative research, groundbreaking treatments, and economic opportunity. According to Grand View Research , the global weight loss and weight management market size was valued at $142.5 With sales soaring to $2.2 for this class of drugs.   billion and $41.6

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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.&

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Fierce BioTech

JANUARY 16, 2025

Yet the process of getting to market and enabling patient access is far from simple. Yet the process of getting to market and enabling patient access is far from simple. Register now to secure your spot.

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Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. However, the treatment journey does not end with weight reduction, as maintaining weight loss overall is equally crucial.

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Drug Target Review

MARCH 3, 2025

The search for effective treatments for neurodegenerative diseases like Parkinson’s disease has long been hindered by the brain’s complexity and the absence of adequate models for drug discovery. This approach has the potential to revolutionise clinical trial design and lead to more effective, personalised treatments.

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Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies?

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The Pharma Data

AUGUST 19, 2021

. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.

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The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval.

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The Pharma Data

FEBRUARY 24, 2022

Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022 Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases. The FDA Breakthrough Therapy designation is supported by data collected to date.

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PPD

JUNE 27, 2024

The PPD clinical research business of Thermo Fisher Scientific has made significant contributions to these indications — our experts have conducted pivotal clinical studies for at least four molecules now on the market. Accelerate your alopecia areata treatments.

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The Pharma Data

JANUARY 7, 2021

The new manufacturing facility will handle cGMP production of CA002, the Company’s proprietary peanut allergy treatment, for planned pivotal clinical trials. We are excited to progress this treatment to market so that the millions of children suffering with peanut allergy will have the choice of a safe and tolerable immunotherapy.”.

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