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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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 213
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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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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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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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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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Powerful New Drug Prevents STIs, But May Come With a Hidden Catch

AuroBlog - Aurous Healthcare Clinical Trials blog

The United States is set to roll out a powerful new weapon in the long fight against sexually transmitted infections: a decades-old antibiotic repurposed as a preventative pill. DoxyPEP, or doxycycline used as a post-exposure prophylaxis, has been found to significantly cut the risk of chlamydia, gonorrhea and syphilis when used after condomless sex.

Drugs 176
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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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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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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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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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‘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.

Doctors 210
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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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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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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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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 156
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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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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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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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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 172
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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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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Moderna's updated COVID shot stands strong against new variants in first look at trial data, company says

Fierce Pharma

Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape, which includes a sh | Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape.

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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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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.

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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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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.

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New patent for Bracco drug LUMASON

Drug Patent Watch

Annual Drug Patent Expirations for LUMASON Lumason is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Bracco drug LUMASON appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.