Wed.Feb 12, 2025

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February 12, 2025: Results of ACP PEACE, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.

Trials 147
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FDA approves Gomekli as first neurofibromatosis drug for adults

Pharmaceutical Technology

Merck acquisition target SpringWorks will go toe-to-toe with AstraZeneca in the US neurofibromatosis market.

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New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

Bio Pharma Dive

A small semaglutide trial suggests the medicine's suppression of appetite may extend to alcohol, but larger tests are needed to establish a conclusive benefit.

Medicine 199
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OCT West Coast 2025: China surpasses US for annual number of clinical trials

Pharmaceutical Technology

GlobalDatas Revati Tatake discussed key trends in biopharma which are set to have an impact in 2025 and beyond.

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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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Aardvark prices $94M IPO to fund Prader-Willi, obesity drug work

Bio Pharma Dive

Proceeds will support testing of drugs designed to suppress hunger in people with the tough-to-treat rare disease and, potentially, more common obesity-related conditions.

Drugs 167
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Travere takes rare disease kidney drug to FDA despite failed trial

Pharmaceutical Technology

Traveres stock price climbed by 14% following the announcement it will seek an FDA label expansion for Filspari.

Trials 162

More Trending

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Abcuro secures $200m as it eyes approval for rare muscle disease drug

Pharmaceutical Technology

The funding will be used to complete the Phase II/III trial of ulviprubart, and to support commercial launch preparation.

Drugs 147
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Biogen inks royalty deal to gain funding for lupus drug R&D

Bio Pharma Dive

The agreement hands Biogen as much as $250 million in exchange for milestone payments and sales royalties for litifilimab, which is in a pair of late-stage studies in lupus.

Sales 135
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Lundbeck gains FDA fast track designation for MSA therapy amlenetug

Pharmaceutical Technology

Lundbeck has received the US FDA fast track designation for amlenetug, a potential treatment for multiple system atrophy (MSA).

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Delivering Compassionate Care Can Transform Lives in Clinical Research

ACRP blog

Many times, individuals who have triumphed over frightening, or even near-death, situations will say that the experience has given them a new and more positive outlook on life. Allison Massari, a two-time survivor of such scenarios, has an additional and unique insightand its on the patient experience. She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinical research in a S

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

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EC grants marketing authorisation to BridgeBio’s ATTR-CM treatment

Pharmaceutical Technology

EC has granted marketing authorisation to BridgeBio Pharmas acoramidis under the Beyonttra brand name for treating ATTR-CM.

Marketing 147
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New Strain of Bird Flu in Nevada Reveals a Concerning Mutation

AuroBlog - Aurous Healthcare Clinical Trials blog

(Dusty Pixel photography/Getty Images) An emerging strain of highly pathogenic avian influenza has spilled over from wild birds to dairy cows in the state of Nevada, and officials at the US Department of Agriculture (USDA) and some scientists are concerned by a mutation they are seeing. The viral variant, called genotype D1.

Genotype 130
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Health Canada approves MSD’s Keytruda for NSCLC stages

Pharmaceutical Technology

Health Canada has approved MSD's Keytruda for treating adults with resectable stage II, IIIA or IIIB NSCLC.

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Judge orders FDA, health agencies to restore removed webpages

Bio Pharma Dive

District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.

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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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Bimekizumab shows long-term efficacy in hidradenitis suppurativa

Pharma Times

UCB's BIMZELX reveals promising two-year data at EHSF 2025

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Budget allocation to DHR witness 40% increase in FY26

AuroBlog - Aurous Healthcare Clinical Trials blog

The proposed budget allocation for the Central sector schemes of Department of Health Research (DHR), under the ministry of health and family welfare, is expected see an increase of almost 40 per cent during the fiscal year 2025-26, as compared to the initial projects under the Budget Estimates (BE) for the fiscal year 2024-25.

Research 113
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Amlenetug receives FDA Fast Track Designation

Pharma Times

Potential treatment for multiple system atrophy shows promise

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With Merck circling, SpringWorks gets new drug approval

pharmaphorum

Merck KGaA is talking to SpringWorks about a takeover, and FDA approval for a neurofibromatosis drug could have sweetened any potential deal.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UPS Welcomes Three New Cross-Dock Plants

Pharmaceutical Commerce

The facilities are expected to offer pharma shipment support by addressing time and temperature-specific requirements.

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Abcuro raises $200m to take muscle disease drug to market

pharmaphorum

Abcuro has raised $200m in financing that should allow it to complete a pivotal trial of ulviprubart for rare disease inclusion body myositis (IBM).

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The Value of Workforce Development and Advanced Data Tools

Pharmaceutical Commerce

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, dives into specific areas where FDA investment could have the greatest impact in accelerating approval timelines.

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BridgeBio gets EU nod for ATTR cardiomyopathy drug

pharmaphorum

BridgeBio and Bayer are poised to challenge Pfizer's Vyndaqel in the EU after acoramidis gets a green light for ATTR cardiomyopathy.

Drugs 78
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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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Beyond the GLP-1 Headlines

Pharmaceutical Commerce

Digging a little deeper into the drug class phenomenon reveals some interesting takeaways on a smaller subgroup of users.

Drugs 52
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Storybook can help kids understand rare kidney disease

pharmaphorum

An e-Book aimed at children with rare kidney disease aHUS can help them understand the condition, deal with emotions, and find support, says Alexion.

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3PLs and New Voices

Pharmaceutical Commerce

Our February issue is highlighted by an examination of the latest trends and strategies from the perspective of third-party logistics providers, and introduces new expert commentary covering a pair of pivotal realms in the pharma supply chain journey.

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How pharmaceutical companies can speed up construction projects

pharmaphorum

Learn how pharmaceutical companies can accelerate construction projects in the biotech and manufacturing sectors by implementing innovative strategies and best practices.

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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

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Pharmaceutical Commerce - February 2025 Issue (PDF)

Pharmaceutical Commerce

Click the title above for a link to open the Pharmaceutical Commerce February 2025 issue in an interactive PDF format.

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JP Morgan Week 2025 – Paul Hastings

pharmaphorum

Join us in our exclusive interview with JP Morgan covering the highlights of Week 2025 and insights from Paul Hastings. Watch the video to get valuable information and updates.

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Pharma Pulse 2/12/25: How Uncertainty & Distrust Damage Relationships with Patients, Health of the Biosimilars Industry & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Nerandomilast Achieves Positive Phase III Results in Progressive Pulmonary Fibrosis

XTalks

Boehringer Ingelheim has announced a major breakthrough following positive topline data from its Phase III FIBRONEER-ILD trial on progressive pulmonary fibrosis (PPF). The study met its primary endpoint by demonstrating a significant absolute change in forced vital capacity (FVC) at Week 52 compared to placebo. FVC, which measures the total amount of air exhaled during a forceful breath, serves as a key indicator of lung health.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.