Tue.Apr 08, 2025

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog

By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t

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Understanding Challenges in Early Parkinson’s Research: Critical Insights from Dr. Tom Babic

Worldwide Clinical Trials

In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Although clinical research in PD began more than 25 years ago, there have been no significant updates in the last decade.

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US risks losing biotech edge to China, report warns

Bio Pharma Dive

“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

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Enhancing Access and Retention in Global, Cross-Border Rare Disease Clinical Trials

XTalks

There are over 10,000 rare diseases affecting an estimated 300 million people worldwide where 80% are genetic , 95% lack approved treatments and nearly half begin in childhood. Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Reflecting on these challenges, Michelle Petersen, MS, Vice-President of Clinical Trial Management at Medpace, noted, When its rare, its personal every

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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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Ethris and Lonza to develop mRNA vaccines for respiratory conditions

Pharmaceutical Technology

Ethris has partnered Lonza for the development of room-temperature stable mRNA vaccine candidates targeting respiratory conditions.

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Top 15 Most Innovative Healthcare Companies of 2025, According to Fast Company

XTalks

In 2024, the healthcare industry made significant waves TIME spotlighted Laguna Health for its AI-powered patient-care platform, while The Healthcare Technology Report recognized 50 trailblazing women leading progress in digital health, AI and medical devices. AI also gained traction across the sector, with UK-based home healthcare company Cera earning a Health Tech Digital Award for its advanced AI tools that support clinical decision-making and enhance home care efficiency.

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Rallybio discontinues lead drug for rare maternal disorder

Bio Pharma Dive

The company has decided to switch gears following disappointing data for a monoclonal antibody targeting a rare maternal blood disorder.

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Valuation of Pharma Companies: 5 Key Considerations

Drug Patent Watch

"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. At DrugPatentWatch, we've identified 5 key considerations that can help you make informed investment decisions. Patent Portfolio Strength : A strong patent portfolio can significantly impact a company's valuation.

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KalVista licenses commercialisation rights for HAE to Kaken in Japan

Pharmaceutical Technology

KalVista has licenced the commercialisation rights for sebetralstat, a hereditary angioedema (HAE) treatment, to Kaken in Japan.

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How to Ensure Patient Safety with Generic Drugs

Drug Patent Watch

Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts. At DrugPatentWatch, we've seen firsthand the impact that generic drugs can have on patients.

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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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Epsilogen acquires TigaTx to expand pan-isotope cancer antibody pipeline

Pharmaceutical Technology

Epsilogen has acquired antibody developer TigaTx in a deal that collates work from the companies alternative antibody isotopes for cancer.

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Kris Kowdley, MD, Is the Lead Author of a New AP&T Article On Clinical Outcomes in Primary Biliary Cholangitis

Velocity Clinical Research

Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, is the lead author of a new article reporting on a study that found prolonged elevation of hepatic biomarkers and fibrosis (scarring) scores is associated with a greater risk of negative clinical outcomes in patients with primary biliary cholangitis (PBC). PBC is a rare liver disease that can lead to cirrhosis or liver failure.

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UK Government to invest $764m into new health data service

Pharmaceutical Technology

The investment is expected to reduce clinical trial set up times.

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A True CRO Partner for Your Multi-Country Clinical Trial

ProRelix Research

Struggling with multi-country clinical trials? Overcome regulatory hurdles, patient recruitment challenges, and data complexities with a true CRO partner. Introduction Carrying out a multi-country clinical trial is indeed an arduous […] The post A True CRO Partner for Your Multi-Country Clinical Trial appeared first on ProRelix Research.

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

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Africa: The clinical impact of the US withdrawal from WHO and USAID

Pharmaceutical Technology

US policy changes to withdraw from the WHO and cut USAID have had clinical repercussions throughout Africa. We explore the impact.

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EU due to meet with pharma today to discuss tariffs

pharmaphorum

European Commission President Ursula von der Leyen is scheduled to meet with EU pharma leaders today about how to respond to US tariffs.

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MHRA approves prostate cancer imaging agent trofolastat

Pharma Times

Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK

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Rinvoq cleared for giant cell arteritis in EU, ahead of US

pharmaphorum

AbbVie has picked up another indication for its JAK inhibitor Rinvoq in the EU, becoming the first approved oral therapy for giant cell arteritis

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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LogiPharma Europe 2025: An Innovative Journey

Pharmaceutical Commerce

The conferences opening keynote case study shares ways to elicit change that not only results in business growth and productivity, but a boost in patient connection as well.

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FDA nod broadens use of Brainomix's stroke AI

pharmaphorum

Brainomix has been granted FDA approval for a new feature for its AI-powered stroke imaging software that could unlock wider use in the US.

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PAP 2025: Navigating Inflation Reduction Act Reforms Amid Uncertainty for 2025

Pharmaceutical Commerce

Kevin Hagan, CEO, Pan Foundation, discusses central concerns for patient assistance programs as changes to Medicare and the Inflation Reduction Act take effect.

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AZ, Daiichi get EU okay for breast cancer drug Datroway

pharmaphorum

AstraZeneca and Daiichi Sankyo have claimed approval from the European Commission for Datroway, their TROP2-directed ADC for breast cancer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma Pulse 4/8/25: Banks Postpone Loans as Tariffs Stoke Fears, GLP-1 and Biosimilars Trends & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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UK unveils £600m investment in health data research

pharmaphorum

The UK government and Wellcome Trust will invest 600m in a Health Data Research Service to unlock the power of NHS patient data for medical research

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PAP 2025: Creating an Independent Patient Assistance Foundation

Pharmaceutical Commerce

In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, lays out the ways to begin transitioning a foundation.

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Obesity and the endoscopy space: Innovative, minimally invasive weight loss

pharmaphorum

Explore innovative and minimally invasive weight loss solutions in the endoscopy space for individuals struggling with obesity. Learn more about Boston Scientific's work in this area.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Maintaining R&D Investments in the IRA Era

Pharmaceutical Commerce

How data-driven insights can help pharma companies balance their revenue management and innovation strategiesincluding resource allocation, pricing, and market access.

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World’s Largest Biopharma Forum for all mRNA Stakeholders

pharmaphorum

Worlds Largest Biopharma Forum for all mRNA Stakeholders Sara.

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Beyond the Hype: GenAI’s Real Impact on Life Sciences Manufacturing

Pharmaceutical Commerce

Taking stock of today's gains and tomorrow's potential for generative artificial intelligence in reshaping the industry.

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How AI Is Influencing Oncology Clinical Trials and Cancer Care

XTalks

Cancer continues to be one of the most significant health challenges globally, prompting an ongoing pursuit of innovation in detection, treatment and patient care. Projections from the American Cancer Society indicate that in 2025 the US will see more than 2 million new cases of cancer , not counting nonmelanoma skin cancers, and over 618,000 people will die from the disease.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud