Tue.Apr 01, 2025

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Itolizumab Shows Positive Phase III Results in First-Line Treatment of Acute GVHD

XTalks

Equillium announced encouraging topline results from its Phase III EQUATOR study evaluating itolizumab in combination with corticosteroids as a first-line treatment for patients with acute graft-versus-host disease (aGVHD). The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD.

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HHS begins layoffs in chaotic fashion

Bio Pharma Dive

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as cuts hit CDER.

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Sanofi’s Qfitlia Gets FDA Approval as First siRNA Therapy for Hemophilia

XTalks

The FDA has approved Sanofis Qfitlia (fitusiran), making it the first approved siRNA therapy for hemophilia A or B, and the first for the conditions with or without inhibitors. It is indicated to prevent or reduce bleeding episodes in patients aged 12 and older, with or without factor VIII or IX inhibitors. Qfitlia is also the first antithrombin-lowering therapy approved for routine prophylaxis in hemophilia A or B.

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RNA editing biotech Airna adds $155M in funding

Bio Pharma Dive

Airna will use the Series B round to launch a Phase 1/2 trial of its lead program for alpha-1 antitrypsin deficiency, a disease targeted by several other firms.

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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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Large pharma drug licensing from China hits high at 28% in 2024

Pharmaceutical Technology

Total deal value of innovator drug licensing agreements involving Chinese biopharma licensors has risen 66% to $41.5 billion in 2024.

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Judge overturns FDA’s lab developed test regulation, siding with industry

Bio Pharma Dive

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

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RIF job losses are underway at HHS agencies; reports

pharmaphorum

Reduction in force (RIF) job losses have started in earnest at US federal agencies, including the FDA and CDC, according to media reports

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Magazine: Are European biopharma manufacturers ‘nearshoring’?

Pharmaceutical Technology

Is 'nearshoring', the preference among pharma and biotech to move operations to the domestic markets versus outsourcing abroad, becoming the norm?

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EVERSANA joins with Veeva in push to 'pharmatise AI'

pharmaphorum

EVERSANA has joined the growing roster of companies partnering with Veeva on the development of GenAI applications for the life sciences industry

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CNS market resurgence: a decade-long slump ends with $80bn milestone

Pharmaceutical Technology

In 2025, the CNS market is forecast to surpass $80bn in sales for the first time since 2013, marking a significant turnaround.

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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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UK first to approve Rotop's prostate cancer imaging agent

pharmaphorum

The UK has given a world-first approval to Rotop's RoTecPSMA, a new imaging agent for detecting lesions in men with prostate cancer

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BioVersys secures patent claims in China for BV100

Pharmaceutical Technology

BioVersys has announced the grant of key patent claims in China for the BV100 technology, the intravenous formulation of rifabutin.

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Diagnexia and Stratipath link up brings AI breast cancer diagnostics to UK

Pharma Times

Collaboration expands AI-based risk profiling tools

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Platform trials: The challenges, benefits, and best practices to maximize results with an EDC platform

Pharmaceutical Technology

Platform trials offer increased flexibility and reduced costs for sponsors and CROs in clinical studies.

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

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ACC25: AZ stakes its claim to the oral PCSK9 category

pharmaphorum

AstraZeneca has revealed phase 2b results with its oral PCSK9 inhibitor AZD0780 as it tries to narrow a lead held by MSD with its rival cholesterol drug

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Reshoring efforts in US FMCG business begins, but cost increases are likely

Pharmaceutical Technology

US-based Johnson & Johnson (J&J) has announced that it will be investing $55bn in new US manufacturing facilities over the next four years.

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The Financial Barrier to GLP-1s

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Colin Banas, MD, DrFirsts chief medical officer, discusses the challenges that many Americans face regarding the affordability of GLP-1 drugs.

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Judge rejects J&J’s $9bn talc settlement for third time

Pharmaceutical Technology

A federal judge in Houston has rejected the third attempt by J&J subsidiary Red River to settle lawsuits related to its talc-based products.

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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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Pharma Pulse 4/1/25: Restructuring Medical Device Supply Chains, Role of Pharmacists in COVID-19 Care and Prevention & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Pfizer’s RSV vaccine wins expanded approval in EU, gaining edge over GSK

Pharmaceutical Technology

Abrysvo is now approved in the EU for adults aged 18 to 59 who are at increased risk of lower respiratory tract disease caused by RSV.

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PM Society announces the launch of The PMi Awards 2025

pharmaphorum

PM Society announces the launch of The PMi Awards 2025 Sara.

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How will AI shape the future of the NHS?

Pharmaceutical Technology

With an increasing demand for NHS services, technology is being positioned as a critical tool in eliminating inefficiencies and delays. The UK governments latest strategy prioritises AI-driven decision-making, advanced data-sharing mechanisms, and the integration of digital platforms to ensure seamless patient care.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The time is right for a grand resurgence of commercial clinical trials in the UK

pharmaphorum

The UK's NHS is poised for a grand resurgence in commercial clinical trials, offering significant opportunities for medical research and innovation. Learn more about the exciting potential for collaboration.

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FDA approves Bavarian Nordic’s freeze-dried mpox and smallpox vaccine

Pharmaceutical Technology

The formulation allows for greater stockpiling, with Bavarian Nordic already working with the US government to add to vaccine reserves.

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ISPE Singapore Affiliate Conference & Exhibition 2025

pharmaphorum

ISPE Singapore Affiliate Conference & Exhibition 2025 Sara.

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Apollomics and LaunXP agree on NSCLC treatment in Asia

Pharmaceutical Technology

Apollomics and LaunXP have signed an agreement to develop and commercialise the formers c-Met inhibitor vebreltinib.

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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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Panel asks Ministry of Ayush to seek higher budget allocation for 2025-26

AuroBlog - Aurous Healthcare Clinical Trials blog

The Parliamentary Panel on Health and Family Welfare has recommended to the Ministry of Ayush to approach the Ministry of Finance and seek higher budgetary allocation at the supplementary demand stage to ensure that no undertaken project or scheme gets suffered for want of requisite funds.

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NHS England abolished: a bold cure or a risky operation?

Pharmaceutical Technology

The establishment of NHS England (NHSE) to undertake functions previously the responsibility of the then Department of Health (now DHSC) took place 13 years ago, following the enactment of the Health and Social Care Act 2012 - primarily the result of policies of the secretary of state for health at the time,Andrew Lansley.

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World’s Most Common Pain Relief Drug May Induce Risky Behavior, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(Yulia-Images/Getty Images) One of the most consumed drugs in the US and the most commonly taken analgesic worldwide may do a lot more than simply take the edge off your headache.

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Pharmaceutical Technology Excellence Awards 2025: NorthWest EHealth

Pharmaceutical Technology

NorthWest EHealth is a winner in the Innovation, Safety, and Diversity categories in the 2025 Pharmaceutical Excellence Awards.

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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