Sat.Aug 10, 2024 - Fri.Aug 16, 2024

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Africa on high alert as mpox cases rise quickly

pharmaphorum

The rapid spread of a new variant of mpox – previously known as monkeypox – has prompted the Africa Centers for Disease Control and Prevention (Africa CDC) to declare a public health emergency.

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J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Fierce Pharma

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

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Medicare reveals results of drug price negotiations

Bio Pharma Dive

The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.

Drugs 304
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Bridging Innovation & Patient Care: The Growing Role of AI

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!

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August 14, 2024: In This Week’s PCT Grand Rounds, Insights From a Pragmatic Trial of Surgical Face Masks

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Runar Solberg of the Norwegian Institute of Public Health will present “Methodological Insights and Lessons Learned From Conducting a Pragmatic Randomized Trial on Surgical Face Masks.” The Grand Rounds session will be held on Friday, August 16, 2024, at 1:00 pm eastern. Solberg is a research scientist in the Centre for Epidemic Interventions Research at the Norwegian Institute of Public Health.

Trials 130
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Incyte builds GvHD presence with Niktimvo approval

pharmaphorum

FDA clears Incyte's potential blockbuster Niktimvo as a treatment for chronic GvHD, making it a companion to the company's Jakafi for the disorder.

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More Trending

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Certa’s CEO Jag Lamba on enhancing pharma supply chain traceability and compliance

Outsourcing Pharma

In an increasingly complex regulatory landscape, pharmaceutical companies face significant challenges in maintaining transparency and accountability across their global supply chains.

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Complying with the DSCSA

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.

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Hypercube — Tackling AI Hallucinations in Medical Summaries

XTalks

Mendel AI and the University of Massachusetts Amherst (UMass Amherst) have published key data on addressing the critical issue of hallucinations in AI-generated medical summaries using a pioneering artificial intelligence (AI) framework called “Hypercube”. This collaboration is a step forward in ensuring the reliability and safety of AI applications in healthcare.

Doctor 98
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Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot

Bio Pharma Dive

The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.

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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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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans

Worldwide Clinical Trials

By: Simran Padam, Medical Director, Medical Affairs Personalized treatment approaches have emerged as pivotal in improving outcomes for hematological cancers. Central to this advancement are biomarkers, which are measurable indicators that signal biological processes or pathological changes within the body. They play a crucial role in tailoring hematology oncology therapeutic strategies to individual patients and have transformed personalized medicine in oncology.

Genetics 195
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Researchers map interactions of 144 active substances to identify drug benefits

Pharma Times

The study yielded over one million dose-responsive curves for existing cancer drugs

Drugs 153
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Lykos to cut 75% of staff after FDA rejection of MDMA-based therapy

Bio Pharma Dive

The layoffs are part of a larger reorganization that will also see the departure of Lykos’ founder, the psychedelics advocate Rick Doblin.

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

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GLP-1 receptor agonists cut risk of death in inflammatory disease patients, says study

Pharmaceutical Technology

GLP-1RAs may be more effective for patients with immune diseases and type 2 diabetes than DPP-4 inhibitors, as per analysed health records.

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Not if, but when: Pandemic preparedness is crucial

pharmaphorum

On Wednesday, 14th August, the World Health Organization (WHO) announced the mpox outbreak in Africa as a public health emergency of international concern (PHEIC). By Thursday, 15th August, the first case of the severe variant was reported in Sweden, marking its emergence outside of Africa.

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Study finds AI reduces underdiagnosis of Black patients with common heart failure

Pharma Times

Heart failure with preserved ejection fraction makes up 50% of all UK heart failure cases

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Galderma wins FDA approval for skin condition treatment

Bio Pharma Dive

Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.

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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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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

Pharmaceutical Technology

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

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People need to know how to use AI now

pharmaphorum

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

Pharma Times

A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke

Vaccine 151
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FDA approves Ascendis drug for rare endocrine condition

Bio Pharma Dive

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

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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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The Genomic Medicine Revolution: Multi-Modality Approaches in Advanced Therapies 

Pharmaceutical Technology

Genomic medicines offer new techniques for treating conditions once thought to be intractable - a world of opportunity awaits.

Genome 246
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With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

Fierce Pharma

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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New research reveals AI bowel cancer test can help patients avoid chemotherapy

Pharma Times

This form of cancer was responsible for 1.

Research 146
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Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

Bio Pharma Dive

Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.

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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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Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pharmaceutical Technology

While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.

Vaccine 246
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AI as an inventor: Defining ownership in the pharma sector

pharmaphorum

AI's role in inventing new drugs raises questions about ownership rights in the pharmaceutical sector. Explore the complexities of defining ownership in drug discovery with AI technology.

Drugs 117
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McMaster drug trial receives more than $6m to test smallpox vaccine against mpox

Pharma Times

Children accounted for the majority of mpox cases and deaths in the DRC since June 2023

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Pfizer builds case for RSV shot with data from immunocompromised adults

Bio Pharma Dive

Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time