Pharmaceutical Technology

JANUARY 14, 2025

This month, pharma companies have announced plans to increase the prices of more than 250 branded drugs in the US.

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Bio Pharma Dive

JANUARY 16, 2025

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference.

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Drugs 361

Rethinking Clinical Trials

JANUARY 13, 2025

From left to right: Dr. Rachel Winer, Dr. Amanda Petrik, and Dr. Jasmin Tiro, principal investigators of the STEP-2 trial The NIH Pragmatic Trials Collaboratory is pleased to welcome the STEP-2 trial (Self-Testing for Cervical Cancer in Priority Populations) to its portfolio of innovative NIH Collaboratory Trials. Only half of eligible patients in US federally qualified health centers were screened for cervical cancer in 2021.

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Trials Clinical Trials Clinical Trials Research 130

XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. Called exPDite-2, the registrational trial meaning a trial designed to gather the necessary data for potential regulatory approval is slated to begin in the first half of 2025.

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

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!

Clinical Trials

Pharmaceutical Technology

JANUARY 13, 2025

NVIDIA starts 2025 by announcing a trio of partnerships and a research collaboration to boost healthcare sector presence.

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Bio Pharma Dive

JANUARY 16, 2025

Roche's core research spans five large areas. Boris Zaïtra, who now leads corporate business development, is confident his team of dealmakers can juggle them.

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Business Development Development Research 317

XTalks

JANUARY 15, 2025

Known for its AI-driven diagnostic tools, IMVARIA, a Berkeley-based health tech company, recently earned the FDAs 510(k) clearance of ScreenDx, a first-of-its-kind algorithm designed to identify potential interstitial lung disease (ILD) cases. This follows their earlier success with Fibresolve , a tool for idiopathic pulmonary fibrosis (IPF) that became the first FDA Breakthrough-designated AI diagnostic for lung fibrosis.

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Pharmaceutical Technology

JANUARY 17, 2025

Shionogis S-892216 is being developed as a pre-exposure prophylaxis (PrEP) drug for Covid-19. Credit: seksan Mongkhonkhamsao via Getty Images.

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Development Drugs 264

Bio Pharma Dive

JANUARY 16, 2025

AbbVie's CEO hinted his company may be less willing to invest in psychiatry after a costly setback, while Lilly explained what it got wrong forecasting GLP-1 drug demand.

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Drugs 316

Rethinking Clinical Trials

JANUARY 16, 2025

Speakers Dana Dailey PT, PhD Assistant Research Scientist Physical Therapy and Rehabilitation Science University of Iowa Associate Professor, Physical Therapy Department St. Ambrose University Heather Schacht Reisinger, PhD Director, Implementation Science Center Associate Director for Engagement, Integration, and Implementation Institute for Clinical and Translational Science Professor, Division of General Internal Medicine at the University of Iowa Slides Keywords Commun

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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

Medicine

XTalks

JANUARY 17, 2025

Johnson & Johnson (J&J) has announced its $14.6 billion acquisition of Intra-Cellular Therapies, which brings Caplyta (lumateperone) to its growing portfolio of mental health treatments. The deal also includes a cash payment of $132 per share for all outstanding shares of Intra-Cellular Therapies. Caplyta is an oral medication that was first approved in 2019 for the treatment of schizophrenia in adults, followed by a 2021 approval for depressive episodes associated with bipolar I and II

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Pharmaceutical Technology

JANUARY 16, 2025

Eli Lilly has received approval from the US FDA for Omvoh to treat moderately to severely active Crohn's disease in the adult population.

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FDA Approval 264

Bio Pharma Dive

JANUARY 13, 2025

The company lost more than $3 billion in market value after cutting its forecast for 2025 revenue from its COVID-19 and RSV vaccines.

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Antidote

JANUARY 16, 2025

When preparing for flu season, those with asthma may have concerns about how the virus can affect their respiratory health and breathing. While asthma is a manageable condition, it does require extra care when dealing with seasonal illnesses like the flu. In this blog, we'll explore how asthma and the flu interact, provide tips for managing both, and offer resources to help you stay informed and prepared.

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XTalks

JANUARY 16, 2025

Qiagen received FDA clearance for its new QIAstat-Dx mini gastrointestinal panel last week. According to Qiagen, the test is the first in a series of QIAstat-Dx gastrointestinal (GI) panel tests for clinical use. The new QIAstat-Dx Gastrointestinal Panel 2 mini B&V (bacterial and viral) is designed for the rapid outpatient diagnosis of gastrointestinal conditions.

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Laboratory Information Management System Bacteria Compliance Genetics 105

Pharmaceutical Technology

JANUARY 16, 2025

Six out of 31 total new small molecules approved by the FDA in 2024 were produced by Wuxi, said the company's co-CEO.

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Bio Pharma Dive

JANUARY 14, 2025

The company said it overestimated demand of its obesity and diabetes drugs in the fourth quarter, but projected a further ramp-up in sales this year.

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Sales Drugs 312

Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations.

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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

Clinical Trials

ACRP blog

JANUARY 17, 2025

The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation in clinical research, I see this milestone as an opportunity for our field to grow and adapt in meaningful ways. ICH E6(R3) isnt just an updateits a call to action.

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Clinical Research Clinical Trials Clinical Trials Trials 72

Pharmaceutical Technology

JANUARY 16, 2025

At the JP Morgan Conference 2025, CEO Chen said the potential of the Biosecure Act passing has had only a minimal chilling effect on clients.

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Bio Pharma Dive

JANUARY 14, 2025

Young drugmakers confront several harsh realities this year, among them a contracting sector and competition from China.

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Drug Patent Watch

JANUARY 14, 2025

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]? That’s right, these unsung heroes are saving our healthcare system trillions of dollars!

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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.

Clinical Trials

ACRP blog

JANUARY 15, 2025

In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the nice to have category into the must-have one doesnt have to be dismissed as a miracle that will never see the light of day, an industry observer of trends in technology says.

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Clinical Research Big Data Research Clinical Trials 59

Pharmaceutical Technology

JANUARY 12, 2025

Intellia expects to incur charges of $8m associated with the reorganisation, which will likely be incurred in Q1 2025.

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Bio Pharma Dive

JANUARY 17, 2025

Novo sells semaglutide as Ozempic and Rybelsus for diabetes and as Wegovy for obesity. In price talks, CMS will treat the different forms as a single product.

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Production Drugs 289

Drug Patent Watch

JANUARY 15, 2025

Identifying drug patents is crucial for various stakeholders, including researchers, legal professionals, and business strategists. While Google Patents is a widely used tool for searching patent information, it may not be the most effective solution for identifying drug patents. This article explores the limitations of Google Patents in this context and suggests alternative approaches.

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Drugs Scientist Engineer Research 59

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

ACRP blog

JANUARY 14, 2025

The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.

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Clinical Research Research Clinical Trials Clinical Trials 59

Pharmaceutical Technology

JANUARY 14, 2025

The CDMO's growth strategy, capital deployment approach, and work with AI, among other things, have been key to its 2024 performance.

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Bio Pharma Dive

JANUARY 13, 2025

Intra-Cellular has had success selling Caplyta, a brain-rebalancing drug that's approved to treat schizophrenia and bipolar depression.

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Drugs Development 255

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). The trial met its primary endpoint of proptosis (protrusion of the eyeball from the orbit) reduction with statistical significance at the 150 mg BID (twice a day) dose.

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Trials Clinical Trials Clinical Trials Insulin 59

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