Sat.Aug 17, 2024 - Fri.Aug 23, 2024

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A Vital Fluid Protects Your Most Important Organ. What Happens if It Fails?

AuroBlog - Aurous Healthcare Clinical Trials blog

Cerebrospinal fluid, or CSF, is a clear, colorless liquid that plays a crucial role in maintaining the health and function of your central nervous system. It cushions the brain and spinal cord, provides nutrients and removes waste products. Despite its importance, problems related to CSF often go unnoticed until something goes wrong.

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South African president calls on WHO for better mpox response

Pharmaceutical Technology

Cyril Ramaphosa, the president of South Africa, has asked the WHO to ensure African countries have equitable access to mpox vaccines.

Vaccine 246
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Study reignites debate on GLP-1 drugs and suicide risk

pharmaphorum

Debate over the safety of GLP-1 drugs resurfaces after study finds 'disproportional' risk of suicidal thinking adverse event reports with Novo Nordisk's semaglutide

Drugs 110
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August 21, 2024: In This Week’s PCT Grand Rounds, Improving Quality of Life in COPD and Heart Failure

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, David Bekelman and Lyndsay DeGroot of the University of Colorado will present “Improving Quality of Life in COPD and Heart Failure: Unpacking a Successful Multicomponent Virtual Team Intervention.” The Grand Rounds session will be held on Friday, August 23, 2024, at 1:00 pm eastern. Bekelman is a professor of medicine and psychiatry at the University of Colorado School of Medicine and the Rocky Mountain Regional VAMC.

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

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As Bristol Myers’ schizophrenia drug nears approval, AbbVie and others hope to provide competition

Bio Pharma Dive

A new wave of antipsychotics could improve patient adherence. The race to corner this large projected market is already getting tight.

Marketing 277
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The future of drug discovery: Using AI to optimise the hit-to-lead process

Drug Discovery World

Mirit Eldor , Managing Director, Life Sciences Solutions, Elsevier, looks at how artificial intelligence (AI) can improve the hit-to-lead process for small molecules. Early drug discovery takes an average of three-to-six years and accounts for 42% of total costs 1 in the development of a new drug. It’s therefore no surprise that pharmaceutical companies are increasingly interested in using artificial intelligence (AI) to accelerate development and reduce costs.

Drugs 110

More Trending

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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Nature publishes new research on genetic causes of colorectal cancer

Pharma Times

In the UK study, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project

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Bavarian Nordic readies 2 million vaccine doses to fight mpox outbreak

BioPharma Reporter

The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organizationâs declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.

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Updated COVID shots from Pfizer, Moderna cleared by FDA

Bio Pharma Dive

The approval of both reformulated messenger RNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.

RNA 271
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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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Novartis and Versant launch Borealis Biosciences with $150m

Pharmaceutical Technology

Novartis has partnered with Versant Ventures to establish Borealis Biosciences, a Canada based independent, discovery-stage biotech company.

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ICMR invites researchers to develop evidence-based guidelines for empirical use of antibiotics

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.

Research 187
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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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BridgeBio sends rare disease drugs to new company

Bio Pharma Dive

Backed by $300 million from investors that include Viking Global Investors and Sequoia Capital, GondolaBio will inherit several BridgeBio drug programs.

Drugs 265
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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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Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

Packaging 246
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Study Finds Humans Age Faster at 2 Sharp Peaks – Here’s When to Expect Them

AuroBlog - Aurous Healthcare Clinical Trials blog

The progress of a human being through life might be thought of as a mostly gradual succession of changes from the ovum to the grave. But if you wake up one morning, look in the mirror, and wonder when you suddenly grew so much older, you may not be imagining things.

Research 196
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Bayer layoffs hit Switzerland with 150 cuts at Basel consumer health hub: reports

Fierce Pharma

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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Lilly’s tirzepatide cuts diabetes risk, study data show

Bio Pharma Dive

Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.

Drugs 271
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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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Eli Lilly acquires Morphic in IBD portfolio expansion

Pharmaceutical Technology

Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.

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Mpox: Disease Expert Explains Why It’s Now a Global Health Emergency

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization (WHO) has declared mpox a public health emergency of international concern, after rising cases in the Democratic Republic of the Congo and the potential for further spread.

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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

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Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Bio Pharma Dive

Company executives had previously warned investors that a delay was likely due to issues at a facility run by third-party manufacturer.

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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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NMPA approves AstraZeneca’s Fasenra for severe asthma

Pharmaceutical Technology

The China NMPA approved AstraZeneca's Fasenra for individuals aged 12 years and older with severe eosinophilic asthma (SEA).

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Surprise Alzheimer’s Finding: Brain’s Support Cells May Be Fueling Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Neurons aren’t the only brain cells producing the proteins associated with Alzheimer’s disease, a new study of mouse models reveals. It turns out that cells supporting neurons contribute to this process too. Amyloid beta proteins occur naturally in our brains, but have long, and now controversially, been associated with Alzheimer’s disease.

Protein 169
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FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

Drugs 123
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Employers foresee higher health costs next year due to rising pharmacy spend

Bio Pharma Dive

Pharmaceuticals like the in-demand GLP-1 drugs for obesity are expected to drive increases in healthcare spending in 2025, per a new employer survey.

Pharmacy 242
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals

Pharmaceutical Technology

The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.

Sales 245
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ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Breaking barriers in science: Thermo Fisher's Melanie Adams-Cioaba on innovation and inclusion

BioPharma Reporter

In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.

Drugs 118
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J&J drug combo for lung cancer approved by FDA

Bio Pharma Dive

Approval of Rybrevant and Lazcluze was supported by results from a study that compared the regimen to AstraZeneca’s widely used drug Tagrisso.

Drugs 197
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The New Age of Decentralized Clinical Trials

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.