Tue.Apr 15, 2025

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April 15, 2024: TAICHIKNEE Randomizes First Cohort in Study to Improve Knee Osteoarthritis Pain

Rethinking Clinical Trials

The TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis.

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ESCMID Global 2025: Climate-informed infectious disease risk management

Pharmaceutical Technology

At the ESCMID Global conference in Austria, the development of climate-informed infectious disease risk management systems was discussed.

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The Vital Role of Biomarkers in Neurodegenerative Pathways Early Phase Unit, Worldwide Clinical Trials

Worldwide Clinical Trials

Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Despite their clinical heterogeneity, these diseases often share overlapping pathological mechanisms, including protein misfolding and aggregation, synaptic dysfunction, neuroinflammation, and axonal degeneration.

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GSK’s Blujepa Wins FDA Approval as First New Class of Antibiotic for UTIs

XTalks

The FDA has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. GSKs Blujepa represents the first new oral antibiotic in almost 30 years to address the growing challenge of antibiotic resistance in UTIs. uUTIs are the most common type of bacterial infection, affecting up to 16 million women in the US each year.

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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

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Bristol Myers stumbles in bid to widen heart drug’s use

Bio Pharma Dive

Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether other drugs like it would similarly struggle in testing.

Drugs 170
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World Hemophilia Day 2025: Women and Girls Deserve Recognition Too

XTalks

This World Hemophilia Day 2025, the bleeding disorders community comes together under the theme Access for all: Women and girls bleed too, spotlighting the long-overlooked experiences of women and girls with inherited bleeding disorders. Hemophilia occurs when a clotting protein is missing or deficient, causing prolonged bleeding that can lead to joint damage and chronic pain.

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Vykat XR Approved as First Treatment for Excessive Appetite in Prader-Willi Syndrome

XTalks

Soleno Therapeutics has announced the FDA approval of Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia an intense, persistent hunger in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder. After a series of failures in the indication, Soleno has achieved a breakthrough with the approval.

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Ironwood’s shares sink as FDA demands new trial for lead drug

Pharmaceutical Technology

The FDA will require an additional Phase III trial for apraglutide, the company's candidate for short bowel syndrome.

Trials 147
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Advancing Rare Disease Trials: Innovation, Partnerships and a Patient Focus

XTalks

The landscape of rare disease clinical trials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes. In a recent interview, Anthea Cherednichenko, MPH, MBA, Vice President, Hematology Franchise Head at Takeda, shared insights with Xtalks into the evolving clinical trial environment, the role of technology and the importance of partnerships in advan

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How collaborative partnerships are driving progress in transformative cell and gene therapies (CGTs)

Pharmaceutical Technology

The latest trends in cell therapies indicate a growing confidence in their effectiveness, an expansion of applications beyond oncology and significant market growth potential. However, the industry must navigate various challenges to fully realize the benefits of these innovative therapies as a panel of industry experts recently came together to discuss.

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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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New data reinforce daratumumab as standard of care for multiple myeloma

Pharma Times

Long-term survival projections suggest improved outcomes for patients

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Coherus divests Udenyca franchise to Intas for up to $558.4m

Pharmaceutical Technology

Coherus BioSciences has completed the sale of its Udenyca (pegfilgrastim-cbqv) franchise to Intas Pharmaceuticals for up to $558.4m.

Sales 130
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J&J keeps forecasts steady as pharma confronts tariff threat

Bio Pharma Dive

While J&J expects tariffs will cost it $400 million this year, the company maintained its earnings estimate and upped its sales guidance for 2025.

Sales 122
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Valneva’s single-dose chikungunya vaccine authorised in Brazil

Pharmaceutical Technology

Valneva has received marketing authorisation from the Brazilian Health Regulatory Agency for its single-dose chikungunya vaccine, Ixchiq.

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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

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Global data highlights effectiveness of romosozumab

Pharma Times

Studies show improved bone mineral density and healthcare cost reductions

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Reveal Genomics and Ona link on ONA-255 development for cancer

Pharmaceutical Technology

Reveal Genomics and Ona Therapeutics have entered a strategic partnership to expedite the clinical development of ONA-255.

Genome 130
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The impact of biosimilars on biologic drug reimbursement models

Drug Patent Watch

"BREAKING: The $100 Billion Question - Can Biosimilars Disrupt the Status Quo in Biologic Drug Reimbursement Models? As the biologic market continues to grow, the impact of biosimilars on reimbursement models is becoming increasingly clear. With the average price of a biologic medication reaching upwards of $100,000 per year, the stakes are high.

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Master the Hidden Economics of Pharmaceuticals—In Under an Hour—with DCI's New eLearning Modules

Drug Channels

In todays fast-moving pharmaceutical marketplace, insight is everything. Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. At Drug Channels Institute (DCI) , we know how critical this knowledge isand how hard it can be to find credible, up-to-date training that fits into a busy professionals schedule.

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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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Analytical Method Development and Validation: Cost-Effective Approaches for Generic Drug Testing

Drug Patent Watch

"Breaking the Bank on Generic Drug Testing? Did you know that Analytical Method Development and Validation can account for up to 70% of the total cost of generic drug testing? At DrugPatentWatch, we've cracked the code on cost-effective approaches to speed up your generic drug testing process without sacrificing quality.

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US starts the clock ticking on pharma tariffs

pharmaphorum

The US has launched a national security probe into the national security implications of importing pharmaceuticals, seen as a precursor to tariffs.

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LogiPharma 2025: LogiPharma to Move to Vienna for Sustainability and Focused Sessions

Pharmaceutical Commerce

Will Robinson, program director, LogiPharma, reveals why the conference will be moved to Vienna moving forward.

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Sanofi's 'daughter of Dupixent' heads to phase 3 in asthma

pharmaphorum

Sanofi is preparing a phase 3 programme for asthma candidate amlitelimab, despite mixed data in a phase 2 trial.

Trials 65
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Conference Connect: Progressing Patient Assistance

Pharmaceutical Commerce

Access USA converges in Philadelphia to explore newand neededsolutions to boost patient outcomes.

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Leveraging data, digitalisation, and artificial intelligence: A new era for medicines regulation

pharmaphorum

Explore how the EU healthcare industry is leveraging data, digitalisation, and artificial intelligence to revolutionise medicines regulation. Learn about the advancements and benefits of this new era.

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Tariffs Galore: Where Do We Stand?

Pharmaceutical Commerce

One expert's take on reshoring pharma manufacturing services in the US amid likely tariffs to drugs looming.

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Norgine on a growth charge again with Theravia takeover deal

pharmaphorum

Netherlands-based pharma group Norgine has expanded its rare disease portfolio with the acquisition of France's Theravia for an undisclosed sum

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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The Cold Chain's Evolution

Pharmaceutical Commerce

The April issue of Pharmaceutical Commerce examines the accelerated activityand many ever-expanding layersof temperature-sensitive transport in pharma.

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Ironwood crashes down as FDA seeks new phase 3 trial

pharmaphorum

Shares in Ironwood fell by a third after it revealed the FDA is insisting on a new phase 3 trial of its short bowel syndrome therapy apraglutide

Trials 59
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Pharmaceutical Commerce: April 2025 Interactive Digital Edition

Pharmaceutical Commerce

View the Pharmaceutical Commerce April 2025 issue in an interactive format.

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“Data is our currency” – with Ginkgo Datapoints’ John Androsavich

pharmaphorum

At Reuters Pharma USA last month, editor-in-chief Jonah Comstock caught up with John Androsavich, general manager of Ginkgo Datapoints, an AI-driven CRO launched by Ginkgo Bioworks last September.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model