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

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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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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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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 245
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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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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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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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More Trending

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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 245
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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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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Scientists Discover a Genetic Variant That Seems to Limit HIV Infection

AuroBlog - Aurous Healthcare Clinical Trials blog

A tiny fraction of people are naturally resistant to HIV infections, and scientists want to understand why. Now an international team of researchers has discovered a new genetic variant in people of African ancestries that appears to restrict HIV replication after an infection sets in.

Genetics 245
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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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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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Prioritizing the Biotech Growth Journey in the CRO-Biotech Partnership

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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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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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 222
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FDA lifts hold on Arcellx’s Gilead-partnered cancer cell therapy

Bio Pharma Dive

The agency had paused testing after a patient death, but is now permitting more types of bridging treatment to help keep participants’ disease at bay.

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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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August 14, 2023: Program Leaders Reflect on Cross-Core Collaboration and Opportunities for the Future

Rethinking Clinical Trials

From left: Kevin Weinfurt and Greg Simon In an interview during the program’s Annual Steering Committee Meeting, Drs. Kevin Weinfurt and Greg Simon reflected on cross-Core collaboration within the NIH Pragmatic Trials Collaboratory and opportunities for growth in the future. More than a decade ago, when the NIH Pragmatic Trials Collaboratory got its start, the focus was on identifying and answering the big questions in terms of how to do research embedded in routine healthcare, said Weinfurt, co

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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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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 187
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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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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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Chiesi forms tech partnership with Aliada

Pharma Times

The collaboration will focus on multiple enzyme cargoes modified using Aliada's modular delivery platform - News - PharmaTimes

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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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Parliamentary Panel asks government to implement Mental Healthcare Act and monitor insurance delivery

AuroBlog - Aurous Healthcare Clinical Trials blog

A Parliamentary Panel that looked into the mental healthcare and management policies in the country has observed that even though the Mental Healthcare Act (MHCA), 2017 was implemented five years back, there is still much work to be done to implement the provisions of the Act effectively.

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The rise of the new pharma marketer in an evolving commercial model

Bio Pharma Dive

Meet the pharma marketer of the future, primed for personalization and powered by technology.

Marketing 246
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Robotics: Transforming cell and gene therapy manufacturing

Pharmaceutical Technology

Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.

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NICE gives green light for MSD's Keytruda

Pharma Times

The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study - News - PharmaTimes

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NIMHANS to focus on training human resources to boost competence in clinical psychology

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institute of Mental Health and Neurosciences (NIMHANS) is accelerating its pace of human resources training to provide the much-needed convenient care. The institute sees the need to build a pool of clinical psychologists to widen the scope of therapy access. India a few years ago accounted for 1.

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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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Botulinum battle heats up with FDA approving Daxxify for cervical dystonia

Pharmaceutical Technology

Daxxify becomes the latest botulinum toxin to make the jump from aesthetics to therapeutics.

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CymaBay begins phase 3 liver disease study

Pharma Times

IDEAL study aims to determine the impact of seladelpar on alkaline phosphatase levels - News - PharmaTimes

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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.