Trending Articles

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‘The bar has risen’: China’s biotech gains push US companies to adapt

Bio Pharma Dive

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.

Drugs 336
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Lilly gains US FDA approval for Omvoh to treat Crohn’s disease

Pharmaceutical Technology

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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JP Morgan 2025: NVIDIA partners with IQVIA, Illumina and Mayo Clinic

Pharmaceutical Technology

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

Research 277
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January 13, 2024: STEP-2 Trial of Cervical Cancer Screening Interventions Joins the NIH Collaboratory

Rethinking Clinical Trials

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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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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Owlstone Medical announces $27 million USD first close in Series E financing round

Pharma Times

Funds to accelerate commercialisation and clinical trials of diagnostic tests

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Qiagen Receives FDA Clearance for First Mini Gastrointestinal Panel

XTalks

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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FDA CDER director Patrizia Cavazzoni announces resignation

Pharmaceutical Technology

Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.

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January 15, 2025: Designing for Diversity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Christopher Lindsell In this Friday’s PCT Grand Rounds, Chris Lindsell of Duke University will present “Design for Diversity.” The Grand Rounds session will be held on Friday, January 17, 2025, at 1:00 pm eastern. Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall

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Pheno Therapeutics granted trial authorisation for MS candidate

Pharma Times

First-in-human trial of PTD802 to commence following UK MHRA approval

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Antiviral Medications for Treatment of Nonsevere Influenza

JAMA Internal Medicine

This systematic review and network meta-analysis evaluates the effectiveness and safety of antiviral treatment for patients with nonsevere influenza and thus support an update of World Health Organization guidelines on antiviral treatment for influenza.

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

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Lilly blames slower-than-expected growth for 2024 sales miss

Bio Pharma Dive

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.

Sales 294
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January 14, 2025: Ethics Consultation Documents Now Available for APA-SM Trial

Rethinking Clinical Trials

Ethics and regulatory onboarding documentation for one of the NIH Pragmatic Trials Collaboratory’s newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the APA-SM trial. The consultations took place by video conference and included representation from the study team, members of the NIH Collaboratory’s Ethics and Regulatory Core , NIH staff, and NIH Collaboratory

Trials 130
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Gilead and LEO Pharma partner to develop oral STAT6 program

Pharma Times

Companies aim to provide new treatments for inflammatory conditions

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Cambodian man dies from bird flu

Medical Xpress

A 28-year-old Cambodian man died from bird flu on Friday after eating sick chickens, the health ministry said.

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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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Patrizia Cavazzoni, key FDA official, to leave agency

Bio Pharma Dive

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change.

Drugs 280
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Pharma to raise prices on more than 250 drugs in the US from January 2025

Pharmaceutical Technology

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

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Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Rethinking Clinical Trials

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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Oxford Drug Design achieves in vivo validation for novel cancer treatment

Pharma Times

Promising results from mouse study lead to expanded trials

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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.

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Navigating Asthma During the Flu Season: Tips for Staying Healthy and Safe

Antidote

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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5 questions facing emerging biotech in 2025

Bio Pharma Dive

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

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Intellia slashes workforce by 27% to focus on late stage CRISPR candidates

Pharmaceutical Technology

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

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Lilly nets a second FDA okay for Omvoh, in Crohn's disease

pharmaphorum

Eli Lilly picks up a second FDA approval for IL-23 inhibitor Omvoh in Crohn's disease, but will it kickstart sales growth

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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AI set to revolutionise pharmaceutical R&D says GlobalData

Pharma Times

Survey finds AI to enhance productivity and cut costs in the next 12 months

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BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

XTalks

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.

Trials 81
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J&J to buy psychiatric drug developer Intra-Cellular for $14.6B

Bio Pharma Dive

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

Drugs 246
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JP Morgan 2025: Thermo Fisher rides momentum to project strong growth in 2025

Pharmaceutical Technology

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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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Ouro makes debut with $120m for autoimmune disease TCEs

pharmaphorum

Ouro launches today with $120m in funding and a plan to develop bispecific antibody-based T cell engagers for autoimmune diseases.

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Actinogen boosts trial with Cambridge Cognition’s digital suite

Pharma Times

Partnership aims to advance Alzheimer's research with innovative tools

Trials 96
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Red light linked to lowered risk of blood clots

Medical Xpress

Humans and mice exposed to long-wavelength red light had lower rates of blood clots that can cause heart attacks, lung damage and strokes, according to research led by University of Pittsburgh School of Medicine and UPMC surgeon-scientists and published today in the Journal of Thrombosis and Haemostasis.

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Tune raises $175M for hepatitis B medicine, epigenetic research

Bio Pharma Dive

The biotech plans to use the funding to advance clinical testing of an epigenetic silencing therapy it hopes could treat chronic hepatitis B infections.

Medicine 202
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time