Fierce Pharma

JUNE 28, 2023

Eco-minded AstraZeneca speaks for the trees. | AstraZeneca—often on the frontlines of environmental stewardship—is expanding its AZ Forest program to the tune of $400 million. With that new investment, the company is raising its commitment to plant and nurture 200 million trees across six continents by 2030—the same year AstraZeneca aims to halve its environmental footprint across its entire value chain.

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MedCity News

JUNE 28, 2023

Through LifeMD’s new weight management program, consumers can gain access to GLP-1 prescriptions like Ozempic and Wegovy, clinical support, lab testing, education and more.

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Fierce Pharma

JUNE 28, 2023

Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” | The dehydrated alcohol injection was turned down due to problems with its chemistry manufacturing and controls, issues which the company believes are addressable, it said in a statement.

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MedCity News

JUNE 28, 2023

Clop, a Russian ransomware gang known for going after healthcare providers, has been recently exploiting a software vulnerability called MOVEit. Johns Hopkins University and its health system were recently victims of a data breach caused by hackers targeting this vulnerability, as was Texas-based Harris Health System.

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Healthcare Provider Healthcare Healthcare 102

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Fierce Pharma

JUNE 28, 2023

With a spring approval in hand, Reata Pharmaceuticals has been waiting patiently to launch its first commercial product, Skyclarys. | After an FDA thumbs up on Reata's approval supplement for Skyclarys, analysts feel confident the newly commercial-stage company can meet—or potentially even exceed—a $45.9 million sales target for 2023.

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MedCity News

JUNE 28, 2023

LGBTQ advocacy groups and clinicians argue that healthcare providers have a responsibility to treat the recent wave of laws banning gender-affirming care for minors like the public health crisis that it is. To do this, providers must educate themselves about the laws in their state and nearby states, fight misinformation and collaborate with nonprofits to deliver care to kids in states where their access is under attack.

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MedCity News

JUNE 28, 2023

For healthcare organizations experiencing difficulty launching and sustaining data-driven performance improvement projects, one potential solution to consider is more flexible organization design and increasing self-service data access.

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Healthcare Healthcare 97

Fierce Pharma

JUNE 28, 2023

Pfizer is on an FDA heater. | Pfizer is on an FDA heater. With a blessing Wednesday for once-weekly growth hormone deficiency (GHD) drug Ngenla, the New York pharma giant has racked up four approvals from the agency over the last five weeks.

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MedCity News

JUNE 28, 2023

An Evernorth study found that in 2021, 25% of adults with ADHD did not receive any treatment, though this is a decrease from 38.5% in 2017. About 21.4% of adults with ADHD received both medication and behavioral therapy in 2021, up from 12.9% in 2017.

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Medical 95

Fierce Pharma

JUNE 28, 2023

Activist investor NexPoint Asset Management is trying to derail Paratek's $462 million sale to Novo Holdings and Gurnet Point.

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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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MedCity News

JUNE 28, 2023

Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.

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Fierce Pharma

JUNE 28, 2023

Alexis Borisy, the founder of multiple biotech companies and self-dubbed “man of many hats,” may have to reduce two of his many duties. | Alexis Borisy, the serial biotech entrepreneur and self-dubbed “man of many hats,” may have to reduce two of his many duties.

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MedCity News

JUNE 28, 2023

Gen Z healthcare workers have different expectations and values than the workforce that preceded them. It’s important for organizations to understand these nuanced differences and anticipate how they’re going to adapt to meet these new standards.

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Healthcare Healthcare Management 91

Pharmaceutical Commerce

JUNE 28, 2023

In an interview with Pharma Commerce Editor, Nicholas Saraceno, Courtney Granville, Director, Scientific Affairs, Drug Information Association, discusses issues impacting broader supply chains.

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Pharma 92

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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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MedCity News

JUNE 28, 2023

Building on the success of HLTH last year, HLTH’s Head of Content Jody Tropeano shared why the theme for the 2023 event, Elevate Humanity, will highlight the encouraging and exciting developments in the healthcare industry across the event agenda, providing reasons for optimism.

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Healthcare Healthcare 87

Medgadget

JUNE 28, 2023

Researchers at the University of Connecticut have developed an ultrasound implant that can assist in opening the blood brain barrier to allow chemotherapy to enter and treat brain cancer. However, unlike cumbersome ultrasound systems, this technology can be implanted directly into the brain, and does not require a follow-up surgery to remove the device later as it degrades away to nothing in the brain over time.

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Specialization Medical Patients Medicine 86

MedCity News

JUNE 28, 2023

TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development purposes.

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Patients 90

Pharmaceutical Technology

JUNE 28, 2023

Research has shown that GLP-1RAs may have the potential to treat chronic metabolic diseases such as non-alcoholic steatohepatitis (NASH).

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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.

Safety

European Pharmaceutical Review

JUNE 28, 2023

According to a report by Verified Market Research, the global high-performance liquid chromatography (HPLC) market is projected to reach a value of $8,084.56 million by 2030, growing at a compound annual growth rate (CAGR) of 5.57 percent from 2023 to 2030. What is driving the HPLC market? Growth of the pharmaceutical and biotechnology industries, plus the need for accurate and precise analytical tools in drug development and quality control are influencing factors.

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Pharmaceutical Technology

JUNE 28, 2023

GSK has received a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine from the US Food and Drug Administration.

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European Pharmaceutical Review

JUNE 28, 2023

Obicetrapib as a treatment for reducing cholesterol levels has potential to be the first cholesteryl ester transfer protein (CETP) inhibitor to advance to clinical practice, data and analytics company GlobalData has reported. This forecast is based on positive data from NewAmsterdam Pharma’s Phase II ROSE2 trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy.

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PharmaTimes

JUNE 28, 2023

Trial involved over 450 women across Europe, Turkey and Canada who were unsuitable for hormone therapy - News - PharmaTimes

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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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European Pharmaceutical Review

JUNE 28, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy. The novel psilocin prodrug MSP-1014, the drug being used in the clinical trial is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression. “This is an exciting milestone a

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Ethics Medicine Pharma FDA 77

Pharmaceutical Technology

JUNE 28, 2023

Cellusion shares Phase I/II clinical development plans for its bullous keratopathy stem cell therapy CSL-001.

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Medgadget

JUNE 28, 2023

Researchers at MIT have developed a metal-free electrode using conductive polymers. The electrode is flexible and strong enough for long-term implantation in the body. The device is intended as an advanced replacement for rigid metal electrodes that can cause tissue damage and scarring over the long term, leading to device failure. The new technology required quite a bit of refinement to achieve the correct properties of flexibility, strength, and electrical conductivity.

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PharmaTimes

JUNE 28, 2023

GLORIA trial shows increased survival levels among newly diagnosed brain cancer patients - News - PharmaTimes

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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

Leads

Scott’s Directories

JUNE 28, 2023

The healthcare industry is a dynamic and ever-evolving field that demands effective marketing strategies to stay ahead of the competition. In today’s fast-paced world, reaching the right audience at the right time is crucial for B2B healthcare marketing success. While traditional marketing methods still hold value, leveraging targeted approaches like healthcare mailing lists can significantly enhance your ROI.

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Healthcare Healthcare Marketing Competition 52

Rep-Lite

JUNE 28, 2023

Picture this: you’re standing at the intersection of innovation and impact, with a career path that combines the art of persuasion with the power to transform lives. Welcome to the world of medical sales, where opportunities abound for those driven to make a difference. In today’s ever-evolving healthcare landscape, the demand for skilled medical sales professionals is skyrocketing.

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Medical sales Medical Sales Medical sales reps 52

Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR). The letter is based on a continuing assessment of inspection data at a third-party filler.

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Food and Drug Administration FDA Safety Food 52

PM360

JUNE 28, 2023

The Creative Floor Healthcare Awards has announced this year’s finalists. Entries have come from the USA, Canada, South America, UK, EU, Australia, Japan, New Zealand, Philippines, Singapore, China, and the Middle East. The Creative Floor Healthcare Awards was founded in 2014 by Shaheed Peera. The aim was to help change the way award shows are run. Not only do the awards celebrate world-class creative but also agency people (various roles), clients, and healthcare companies.

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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.

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