Trending Articles

article thumbnail

‘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 360
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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
article thumbnail

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.

Trials 130
article thumbnail

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

article thumbnail

A chain reaction: HIV vaccines can lead to antibodies against antibodies

Medical Xpress

Many vaccines work by introducing a protein to the body that resembles part of a virus. Ideally, the immune system will produce long-lasting antibodies recognizing that specific virus, thereby providing protection.

Antibody 128
article thumbnail

Pheno Therapeutics granted trial authorisation for MS candidate

Pharma Times

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

Trials 124

More Trending

article thumbnail

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

article thumbnail

New study shows stem cell therapy 'jump-start' brain repair after stroke

Medical Xpress

Every 40 seconds, someone in the United States has a stroke. For survivors of the most common type of stroke, called an ischemic stroke, only about 5 percent fully recover. Most others suffer from long-term problems, including weakness, chronic pain, or epilepsy.

118
118
article thumbnail

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

article thumbnail

JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson

Bio Pharma Dive

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.

Drugs 296
article thumbnail

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

article thumbnail

“Nothing to do with geopolitics”: WuXi Biologics CEO bullish in face of Biosecure

Pharmaceutical Technology

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.

264
264
article thumbnail

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
article thumbnail

CDC wants faster testing for bird flu in hospitals

pharmaphorum

Hospitals should expand and speed up testing of people hospitalised with influenza to see if they are suffering from bird flu, says CDC.

117
117
article thumbnail

Gilead and LEO Pharma partner to develop oral STAT6 program

Pharma Times

Companies aim to provide new treatments for inflammatory conditions

article thumbnail

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

article thumbnail

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
article thumbnail

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.

article thumbnail

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

Trials 100
article thumbnail

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.

article thumbnail

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.

article thumbnail

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

article thumbnail

Roche’s new deals head tries to navigate a more ‘complicated’ and ‘expensive’ biotech world

Bio Pharma Dive

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.

article thumbnail

Shionogi awarded $375m from HHS for preventative Covid-19 injectable

Pharmaceutical Technology

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

article thumbnail

Sepsis molecule discovery could lead to improved treatments for critically ill patients

Medical Xpress

Researchers at Oregon Health & Science University have uncovered how a molecule found on certain bacteria may drive blood clotting in sepsis, a life-threatening condition that causes about 8 million deaths per year.

Bacteria 110
article thumbnail

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.

article thumbnail

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.

98
article thumbnail

Oxford Drug Design achieves in vivo validation for novel cancer treatment

Pharma Times

Promising results from mouse study lead to expanded trials

In-Vivo 115
article thumbnail

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.

292
292
article thumbnail

JPM 2025: WuXi AppTec rebuffs concern about lower GLP-1 demand after Lilly’s low revenue forecast

Pharmaceutical Technology

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

264
264
article thumbnail

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.

article thumbnail

Keros pulls study of Winrevair rival after safety signal

pharmaphorum

Adverse events have led Keros to abandon a phase 2 trial of pulmonary arterial hypertension drug cibotacept, a would-be rival to MSD's Winrevair

Trials 105
article thumbnail

J&J Acquires Schizophrenia Drug Caplyta in $14.6 Billion Deal

XTalks

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

Drugs 91
article thumbnail

Biofidelity and CellCarta partner to deploy Aspyre Lung in global clinical trials

Pharma Times

New partnership to advance precision medicine in lung cancer diagnosis

article thumbnail

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
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time