Tue.May 09, 2023

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Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

Fierce Pharma

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion zbecker Tue, 05/09/2023 - 10:51

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Let's make a deal: Conditions are right for biopharma M&A to break out, analysts say

Fierce Pharma

Let's make a deal: Conditions are right for biopharma M&A to break out, analysts say kdunleavy Tue, 05/09/2023 - 10:18

Biopharma 213
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The Future Is Stormy for Us Healthcare: Here Are 3 Strategies to Weather It

MedCity News

US healthcare faces a gathering storm of difficulties, including inflation, labor shortages (particularly of nurses and physicians), and endemic Covid-19. Taking action in three areas could help the entire industry rise above the turbulence.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gilead notches trial win in high-stakes HIV patent case against US government

Fierce Pharma

Gilead notches trial win in high-stakes HIV patent case against US government zbecker Tue, 05/09/2023 - 16:24

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Ginkgo and Boehringer partner to develop hard-to-treat disease therapies

Pharmaceutical Technology

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

Biopharma 104

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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We want your stories: Biopharma's collective memory of COVID—in photographs

Fierce Pharma

We want your stories: Biopharma's collective memory of COVID—in photographs aliu Tue, 05/09/2023 - 14:56

Biopharma 154
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How Baxter’s $4B Sale of Biopharma Biz Fits With Broader Life Sciences Trends

MedCity News

Baxter International is selling its biopharma solutions business to private equity firms. The transaction is part of a broader trend in which life science firms are spinning out or selling operations in order to hone the focus of the remaining business on certain areas.

Biopharma 104
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Lilly exec blasts IRA's 'nonsensical' distinctions as pharma readies legal attacks elsewhere

Fierce Pharma

Lilly exec blasts IRA's 'nonsensical' distinctions as pharma readies legal attacks elsewhere aliu Tue, 05/09/2023 - 10:54

Pharma 130
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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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Recognizing Mental Healthcare Efforts Benefits Both Patients and Providers

MedCity News

Recognizing exceptional mental healthcare providers can lead to improved patient outcomes. Patients tend to have a better experience when they feel appreciated and valued. Acknowledging the efforts of mental healthcare providers can enhance the quality of care provided and, in turn, lead to better patient outcomes.

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BMS, after last year's West Coast purge, lays off 48 in New Jersey

Fierce Pharma

BMS, after last year's West Coast purge, lays off 48 in New Jersey fkansteiner Tue, 05/09/2023 - 11:16

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Roche Forks Over $70M for Brain-Penetrating Cancer Drug Candidate

MedCity News

Roche is acquiring global rights to a Zion Pharma Limited drug candidate with potential applications treating breast cancer that has metastasized to the brain. The small molecule, currently in Phase 1 testing, is designed to penetrate the blood-brain barrier.

Pharma 99
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The Ultimate Guide to Healthcare SEO: 3 Techniques Your Website's Organic Marketing Needs

Healthcare Success

A successful health system, hospital, practice, or healthcare organization website facilitates patient communication and helps you win more of the patients you want. But this doesn’t mean much if patients can’t find your website. To get on page #1 for an organic search, you need a strong healthcare marketing SEO company, a solid website, an even stronger medical SEO strategy, and a tactical SEO team.

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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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CCC Wins Five Top Workplaces Cultural Excellence Awards

Copyright Clearance Center

May 9, 20 23 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has earned several 2023 Top Workplaces Culture Excellence Awards for Compensation & Benefits, Innovation, Leadership, Purpose & Values, and Work-Life Flexibility. Issued by Energage , the research company with more than 17 years of experience surveying over 27 million employees at 70,000 organizations, the Top Workplaces Culture Excellence Awards celebrate companies tha

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Baxter to sell BPS business to Advent and Warburg Pincus for $4.25bn

Pharmaceutical Technology

Baxter International has signed a definitive agreement to sell its BioPharma Solutions (BPS) business to private equity investor Advent International and growth investor Warburg Pincus, in a deal valued at $4.25bn in cash. BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries.

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3 Recent Healthcare Wins for Employers

MedCity News

Amid the difficult healthcare environment, it’s important to note that there have been some wins for employers, said Katy Spangler, senior advisor of the American Benefits Council, during the Midwest Business Group on Health conference held Tuesday. These wins include the No Surprises Act and price transparency rules.

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5 Sales Training Courses That Will Make You Outshine Competitors

MedReps

While you don’t necessarily need a specialized medical sales training course in order to qualify for a job in the field, it never hurts to have this type of training. After all, the field is fairly competitive and employers want to hire workers who they know will be able to get the job done. By attending and completing a medical sales training course, your resume may put you at the top of the candidate list, pushing you past your competitors.

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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.

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Here’s a Preview of the Startups Pitching in the Medical Device Track at MedCity INVEST

MedCity News

Finalists for the medical device track include an innovative, waterproof alterative to casts, a device geared to trauma care, an approach to improve early detection of lung cancer, cardiac monitoring medtech, and more. Register for the conference today!

Medical 94
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This ‘hot-blooded’ CEO is aiming to transform the way burn victims heal

PharmaVoice

Cutiss CEO Daniela Marino is funneling her bold personality and expertise in regenerative medicine into a startup developing bioengineered skin grafts.

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State, Federal Policy Should Exempt Medical Devices from ‘Right-to-Repair’ Movement

MedCity News

While there are many consumer technology and electronic products for which the right to repair ideology may not have much of a safety risk, or perhaps even be beneficial, life-saving medical devices should not be among them.

Medical 90
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CCC to Host Virtual Town Hall ‘Making Research Data FAIR’ on 10 May

Copyright Clearance Center

The post CCC to Host Virtual Town Hall ‘Making Research Data FAIR’ on 10 May appeared first on Copyright Clearance Center.

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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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‘Abortion Trafficking’: Taking a Minor Out of State for an Abortion Is Now a Crime in Idaho:

MedCity News

Mackenzie Davidson grew up in a Mormon household and sheepishly admits she knew little about […]

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RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

Medgadget

RF (radio frequency) technology uses radio waves to transmit and receive information wirelessly. RF is often seen in health monitoring devices such as wearables, implants, remote monitoring systems, and telemedicine. Mostly, though, it is used for communications, but the folks at Movano Health believe that they can use RF to monitor things like blood pressure and blood glucose.

FDA 77
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Who’s saying what? Cybersecurity mentions in company filings of pharmaceutical industry increased by 113% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 113% rise in company filings mentions of cybersecurity in Q1 2023 compared with the previous quarter, with the highest share accounted for by Alnylam Pharmaceuticals with 114% year-on-year increase, according to GlobalData’s analysis of over 667 pharmaceutical company filings. GlobalData’s Cybersecurity in Healthcare – Thematic Research market report helps get a detailed understanding on how Cybersecurity impacts the value chain in the

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Urine Test Could Reveal Cancer and Metastases

Medgadget

Researchers at MIT have developed a urine test that can distinguish between different types of cancer, and could even highlight if metastases are present. The test involves first administering nanoparticles to patients that can circulate around their blood before encountering a tumor. Enzymes that are overexpressed by the tumor can then cleave a linker on the particle surface, releasing a DNA barcode into the blood.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Who’s saying what? Cybersecurity mentions in company filings of pharmaceutical industry increased by 113% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 113% rise in company filings mentions of cybersecurity in Q1 2023 compared with the previous quarter, with the highest share accounted for by Alnylam Pharmaceuticals with 114% year-on-year increase, according to GlobalData’s analysis of over 667 pharmaceutical company filings. GlobalData’s Cybersecurity in Healthcare – Thematic Research market report helps get a detailed understanding on how Cybersecurity impacts the value chain in the

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Vein on a Chip Includes Flexible Valves

Medgadget

Researchers at the University of Birmingham in the United Kingdom have developed a microfluidic device that mimics a human vein, including anatomical features such as valves, and physiological features such as pulsatile flow. The device is intended to make it easier to study processes such as blood clotting, which could help scientists to develop new treatments for conditions such as deep vein thrombosis.

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The State of Scholarly Metadata: 2023

Copyright Clearance Center

The post The State of Scholarly Metadata: 2023 appeared first on Copyright Clearance Center.

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Led by the Pfizer-Seagen deal, ADCs are starting to ‘take center stage’

PharmaVoice

Antibody-drug conjugates got a major boost with the megamerger of Pfizer and Seagen, and experts believe they will continue to be an important catalyst in biopharma.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.