Sat.Aug 12, 2023 - Fri.Aug 18, 2023

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Radiopharmaceuticals for cancer: Making radiation precise

Bio Pharma Dive

More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.

Drugs 246
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9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Worldwide Clinical Trials

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.

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We Just Got An Unprecedented Look At The Details of Cell Division

AuroBlog - Aurous Healthcare Clinical Trials blog

By replacing fluorescent molecules in an existing imaging process with ones that instead scatter light, researchers have revealed a whole new level of dazzling details within our living cells. The innovative tweak will allow scientists to directly observe molecular behavior over a much longer period, opening a window onto pivotal biological processes like cell division.

Scientist 217
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Researchers publish early results with new interleukin-targeting antibody

Pharmaceutical Technology

The biologic was able to halt disease progression in rheumatoid arthritis with the same effectiveness as gold-standard treatment Remicade.

Antibody 246
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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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Blue Shield of California drops CVS Caremark in pharmacy benefit overhaul

Bio Pharma Dive

BSCA has kicked CVS Caremark, the largest pharmacy benefit manager in the country, to the curb and is electing to carve out various pharmacy functions with companies like Amazon instead.

Pharmacy 246
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August 17, 2023: American Journal of Bioethics Publishes Special Issue on Pragmatic Clinical Trials

Rethinking Clinical Trials

When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. To address these questions, the American Journal of Bioethics ( AJOB ) recently published commentaries on 2 target articles in a special issue on pragmatic clinical trials.

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HebeCell and Logomix partner to develop PSC-NK cells

Pharmaceutical Technology

HebeCell has forged a strategic collaboration with Logomix for researching and developing gene-edited natural killer cells (NK cells).

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Gilead antibody drug shows signs of potential in early lung cancer

Bio Pharma Dive

A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.

Antibody 246
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August 16, 2023: In This Friday’s PCT Grand Rounds, the Draft Revision of the ICH Good Clinical Practice Guideline

Rethinking Clinical Trials

From left: Martin Landray, Khair ElZarrad, and Adrian Hernandez In this Friday’s PCT Grand Rounds, Martin Landray of the University of Oxford, Khair ElZarrad of the US Food and Drug Administration, and Adrian Hernandez of Duke University will present “Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6[R3]).” The Grand Rounds session will be held on Friday, August 18, 2023, at 1:00 pm eastern.

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‘Useless’ Organ That Doctors Often Remove May Actually Fight Cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

There’s a small fatty gland that sits behind your sternum and is often said to be ‘useless’ in adulthood.

Doctor 213
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Bruker to buy cell biology company PhenomeX for $108m

Pharmaceutical Technology

Bruker has entered into a definitive agreement to acquire functional cell biology company PhenomeX for a total equity value of $108m.

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FDA approves bispecific drug from Pfizer for multiple myeloma

Bio Pharma Dive

Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

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Biogen kicks off 1,000 layoffs as part of CEO Viehbacher’s ‘complete redesign’

Fierce Pharma

It was only last spring that Biogen started a | It was only last spring that Biogen started layoffs that eventually shrank the company’s headcount by nearly 900 people last year. Now, a fresh round of job cuts targeting 1,000 positions has kicked off at the struggling drugmaker. At the same time, Biogen is spending $7.3 billion to buy rare disease specialist Reata Pharmaceuticals.

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e-pharmacies informed CDSCO they are only providing online platform connecting users & pharmacies: Minister

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […]

Pharmacy 159
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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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AbbVie achieves win for migraine prevention drug Aquipta in Europe

Pharmaceutical Technology

The decision brings the first daily oral migraine prophylactic to Europe, with plans to rollout the treatment as soon as possible.

Drugs 246
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FDA won’t hold advisory meeting for Bluebird’s sickle cell gene therapy

Bio Pharma Dive

The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review.

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Elrexfio Becomes Pfizer’s First Approved Multiple Myeloma Drug

XTalks

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug. However, Elrexfio will be going up head-to-head against Johnson & Johnson’s BCMA-targeted therapy Tecvayli (teclistamab).

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A Strange World of Organisms Lives Inside You, But Not Like You Think

AuroBlog - Aurous Healthcare Clinical Trials blog

There’s a whole world inside your gut, made up of mostly harmless microbes that reside in the gastrointestinal tract.

Bacteria 175
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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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Leprosy potentially endemic in Central Florida

Pharmaceutical Technology

The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.

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Why high-tech solutions require high-touch service to create value in today’s complex drug development landscape

Bio Pharma Dive

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

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Merck's Keytruda will top pharma's sales rankings in 2028, with Roche taking the company category crown: Evaluate

Fierce Pharma

Despite all the upheaval in the pharma industry over the last few years, many familiar names will remain at the top of the industry's sales charts toward the end of the decade. | Merck cancer superstar Keytruda is projected to be the world’s top selling drug by a huge margin in 2028, according to a report by Evaluate. On its list of top 10 drugs by sales in 2028, Keytruda is expected to top the $30 billion mark, with no other therapy predicted to reach $20 billion in sales.

Sales 98
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New Culture is Scaling up to Produce Record Amount of Animal-Free Mozzarella

XTalks

New Culture, one of several emerging startups using precision fermentation to produce casein proteins, has scaled up its fermentation process to now make manufacturing volumes, specifically for its animal-free mozzarella. The company is confident that it can scale up while maintaining price parity with traditional mozzarella within the next three years.

Protein 98
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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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FDA will not meet ahead of bluebird bio’s sickle cell disease gene therapy PDUFA date

Pharmaceutical Technology

Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.

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Precision sells lymphoma drug to Imugene in retreat from cell therapy research

Bio Pharma Dive

The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.

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MSF, trying to secure supplies of ViiV's Apretude, calls out new clauses in purchasing contract

Fierce Pharma

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company's long-acting HIV prevention drug, Apretude, | The advocacy organization has been trying to lock down supplies of ViiV's long-acting Apretude for more than a year. Now, it's asking the HIV-focused company to remove recently added clauses in the contract that it says derail transparency.

Drugs 98
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What is primary sclerosing cholangitis (PSC)?

Antidote

Primary sclerosing cholangitis (PSC) is a condition that impacts the bile ducts of the liver, causing them to become inflamed and ultimately scar. It primarily affects young and middle-aged men, and 80% of patients with PBC also have inflammatory bowel disease (IBD).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EMA accepts for review Iveric Bio’s MAA for geographic atrophy therapy

Pharmaceutical Technology

Astellas Pharma has announced that EMA has accepted the MAA from its subsidiary Iveric Bio for the review of ACP to treat GA.

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Gilead allies with targeted drug startup Tentarix in latest research bet

Bio Pharma Dive

San Diego-based Tentarix will receive $66 million in cash and equity from Gilead, which holds an option to acquire up to three of the company’s subsidiaries.

Research 242
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Lilly's $13.5M insulin pricing settlement gets pushback from 9 states

Fierce Pharma

Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. | In a Tuesday filing in New Jersey Federal Court, lawyers for several states urged U.S. District Judge Brian Martinotti to delay the approval of Lilly's proposed $13.5 million settlement unless it’s altered to make sure states can still file their own insulin pricing lawsuits.

Insulin 98
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Vaxxinity Alzheimer’s treatment shows promising results in early trial

BioPharma Reporter

Vaxxinity has announced the publication of its phase 2 clinical trial data for UB-311, stating that the treatment was safe, well-tolerated and demonstrated a trend for slowing cognitive decline in mild Alzheimer's disease (AD).

Trials 98
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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.