Bio Pharma Dive
APRIL 14, 2025
The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.
Pharmaceutical Technology
APRIL 14, 2025
Kyowa Kirin has concluded the construction of its new drug substance (DS) manufacturing facility, the HB7 building in Japan.
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Drug Patent Watch
APRIL 14, 2025
"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies. At DrugPatentWatch, we've seen firsthand the importance of staying on top of regulatory changes and maintaining a robust compliance program.
Pharmaceutical Technology
APRIL 14, 2025
Phase Ib results show VERVE-102 reduced LDL-C levels with no serious safety issues, unlike Verves VERVE-101 programme.
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!
Bio Pharma Dive
APRIL 14, 2025
As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S. tariffs on their products.
Pharmaceutical Technology
APRIL 14, 2025
Sandoz is suing Amgen over alleged patent abuse delaying the US launch of a biosimilar to the autoimmune drug Enbrel.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
APRIL 14, 2025
On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods. The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. For years, drug makers have relied on animal studies using rodents, dogs or primates to flag safety concerns, even though these models often fall short in pred
Bio Pharma Dive
APRIL 14, 2025
Signs of potential liver damage in a study participant led the company to abandon danuglipron, a drug it hoped would help it break into the highly lucrative market for obesity drugs.
ACRP blog
APRIL 14, 2025
This is a sponsored message. Technology has undeniably contributed to growing chaos at research sites. Seventy percent of sites report using more than six systems per trial, and for the first time, managing these systems is their top challenge. The impact is significant: 52% of sites are struggling to take on new studies, and sponsors are seeing a 45% increase in timelines from protocol approval to first-patient-first-visit.
Bio Pharma Dive
APRIL 14, 2025
Wall Street analysts said the results for Verve’s therapy appeared competitive on efficacy, while avoiding any major safety concerns — at least so far.
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
FDA Law Blog
APRIL 14, 2025
By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV). As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards.
Pharmaceutical Technology
APRIL 14, 2025
Pfizer still has another obesity pill in development, PF-07976016, which is currently in a Phase IIa trial.
Bio Pharma Dive
APRIL 14, 2025
The rare disease drug landscape is evolving, with regulatory guidance shaping its future. Learn more.
Pharmaceutical Technology
APRIL 14, 2025
The chronic obstructive pulmonary disease (COPD) market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $11.6bn in 2023 to $30.2bn by 2033, representing a compound annual growth rate of 10%, according to leading data and analytics company GlobalData.
Bio Pharma Dive
APRIL 14, 2025
Discover how QIAGEN PGXI transforms pharmacogenomics with faster, more accurate insights!
Pharmaceutical Technology
APRIL 14, 2025
Additional melanoma patients will have access to Scancells DNA vaccine as part of an ongoing clinical trial.
Bio Pharma Dive
APRIL 14, 2025
Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured EMR
Pharmaceutical Technology
APRIL 14, 2025
The FDA has granted approval for Bristol Myers Squibbs (BMS) Opdivo (nivolumab) in combination with Yervoy (ipilimumab)
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Sciensano
APRIL 14, 2025
cancer care Event type: conference Audience: policy makers scientists university staff Young patients with cancer Description: We are excited to announce an upcoming event dedicated to accelerating supportive cancer care in Belgium. The event will present the latest developments in the BeONCOsup initiative , whose first outcome is the development of the Belgian eHandbook for (Hemato-)Oncological Supportive Care.
Pharma Times
APRIL 14, 2025
Birmingham researchers to make MGUS monitoring more efficient
pharmaphorum
APRIL 14, 2025
Roche has claimed a first-in-class approval in the EU for Columvi in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Pharma Times
APRIL 14, 2025
Major update aims to accelerate research and strengthen patient safety
pharmaphorum
APRIL 14, 2025
Bristol-Myers Squibb has claimed its second FDA approval in just a few days for its Opdivo/Yervoy combination, this time in liver cancer.
Pharmaceutical Commerce
APRIL 14, 2025
How artificial intelligence tools are helping to optimize the pharmaceutical transport process.
pharmaphorum
APRIL 14, 2025
The use of AI outcome prediction models (OPMs) in medicine is on the rise, but a new paper has warned widespread use could lead to patient harm.
Pharmaceutical Commerce
APRIL 14, 2025
Exploring the importance of contract development and manufacturing organizations in advancing the latest technology for effective delivery of temperature-sensitive medicines.
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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.
pharmaphorum
APRIL 14, 2025
Pfizer has been forced to discontinue its oral GLP-1 receptor agonist danuglipron after seeing signs of liver toxicity in late-stage clinical testing.
Pharmaceutical Commerce
APRIL 14, 2025
In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris ODell, Turquoise Healths SVP of market solutions, discusses the biggest challenges healthcare organizations currently face in terms of price transparency.
pharmaphorum
APRIL 14, 2025
Artificial intelligence, particularly advanced natural language processing (NLP), offers a potential solution to duplication through what can be described as "intelligent content adaptation"
Pharmaceutical Commerce
APRIL 14, 2025
Steffen Lang, president, operations, executive committee member, Novartis, discusses what to expect from Novartis over the next decade in terms of technological innovations.
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