Trending Articles

article thumbnail

Moderna gets $590M from US government for bird flu vaccine

Bio Pharma Dive

Moderna has been testing an mRNA candidate for influenza viruses like the H5 and H7 strains that are seen as pandemic threats. Others, including GSK and Pfizer, are also at work on similar shots.

article thumbnail

Streamlining mesenchymal stem cell (MSC) expansion

Pharmaceutical Technology

With increasing demand for cell and gene therapies, mesenchymal stem cells (MSCs) have gained attention for their versatility and potential.

Insiders

Sign Up for our Newsletter

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

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

January 21, 2025: In PRIM-ER Trial, Palliative Care Training in Emergency Departments Did Not Reduce Hospital Admissions

Rethinking Clinical Trials

Dr. Corita Grudzen and Dr. Keith Goldfeld, principal investigators for PRIM-ER An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial. The results were published online ahead of print in JAMA.

Trials 162
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

Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Worldwide Clinical Trials

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest? Rigorous procedures to ensure that drugs are effective and safe.

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 125

More Trending

article thumbnail

NVIDIA champions Innophore partnership to model drug dynamics with AI

Pharmaceutical Technology

Innophore will launch the CavitOmiX AI tool to screen for new drugs, predict side effects, and repurpose existing molecules.

Drugs 268
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 105
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.

119
119
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

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

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

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 102
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.

117
117
article thumbnail

UK sees 70% increase in phase I advanced therapy clinical trials in 2024

Pharma Times

Cell and Gene Therapy Catapult reveals significant growth in UK trials

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

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

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.

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

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 114
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

Sun Pharma unit poised to buy Canadian biotech Antibe

pharmaphorum

Sun Pharma's Taro unit has made a bid to acquire Canadian biotech Antibe, a developer of drugs for pain and inflammation

article thumbnail

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Bio Pharma Dive

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.

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

Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

XTalks

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology.

Antibody 105
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

AlzeCure’s NeuroRestore ACD856 to be presented at AD/PD 2025

Pharma Times

Preclinical data highlights potential in treating Alzheimer's disease

110
110
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

AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer

Bio Pharma Dive

The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market opportunity analysts estimate to be worth about $500 million annually.

Marketing 161
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

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

Top 10 Pharma and Biotech M&As in the Past Decade

XTalks

The pharma and biotech sector has witnessed impressive growth over the past decade, driven by innovations and strategic partnerships. Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach.

Marketing 104
article thumbnail

Datapharm expands into US market through partnership with phactMI

Pharma Times

Collaboration aims to enhance accessibility of medicines information

Marketing 108
article thumbnail

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

article thumbnail

Sionna, Odyssey join queue of biotechs testing investors’ IPO interest

Bio Pharma Dive

The startups are the fourth and fifth drugmakers to file for initial public offerings since late December — the most notable burst of activity in more than three months.

161
161
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time