Thu.Mar 30, 2023

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As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal

Fierce Pharma

As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal aliu Thu, 03/30/2023 - 10:39

Marketing 280
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How Remote Patient Monitoring Can Help Advance Health Equity

MedCity News

The recent growth in RPM has demonstrated its importance and potential to reduce or eliminate barriers and improve access to care for patients. By leveraging RPM and other digital health solutions as an important part of a multi-prong approach to care delivery, a future where all patients have equal access to high-quality healthcare becomes a closer reality.

Patients 132
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Trending Sources

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Pfizer, BMS' Eliquis tops list of drugs destined for Medicare price negotiations in 2026: Moody's

Fierce Pharma

Pfizer, BMS' Eliquis tops list of drugs destined for Medicare price negotiations in 2026: Moody's kdunleavy Thu, 03/30/2023 - 07:28

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When It Comes to Radiology, What Can We Teach ChatGPT ?

MedCity News

The potential of ChatGPT is exciting. Radiologists have come a long way on the AI journey. What started as a fear from some that AI would replace us, has evolved to a more nuanced understanding that AI’s greatest contribution in medical imaging is to make us better radiologists.

Medical 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Fierce Pharma Asia—Takeda's manufacturing expansion; Leqembi's sales prospects; GSK's PrEP generics

Fierce Pharma

Fierce Pharma Asia—Takeda's manufacturing expansion; Leqembi's sales prospects; GSK's PrEP generics aliu Thu, 03/30/2023 - 16:18

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Ohio Sues Express Scripts, Cigna, Prime Therapeutics and Humana Calling PBMs “Modern Gangsters”

MedCity News

The complaint alleges multiple violations of the Valentine Act, Ohio’s antitrust law, which prohibits price fixing, controlled sales and other agreements that restrain trade and hurt competition. David Yost, the attorney general decried the practices of PBMs saying that they hurt everyday Ohioans dependent on life-saving drugs like insulin.

More Trending

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MedCity Pivot: Blue Shield of California CEO Says Value of HealthTech Has Been Mixed So Far

MedCity News

Paul Markovich believes in the value of health tech in managing both chronic diseases and in general health and wellness. In this episode, he talks about the company’s Wellvolution platform and the digital tools that are offered there to members, now even to those on Medicaid.

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CGT: Collaborate to Scale

PharmExec

At Pharma USA 2023, Peter Marks, MD, PhD and director of CBER described FDA and public/private partnerships working toward scalable manufacturing approaches to address commercial viability and global access for cell and gene therapies

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Get To Know the 23 Startups AWS Chose for Its Workforce Development Accelerator

MedCity News

Last fall, AWS announced that it was launching a new accelerator to support startups that develop technology to help the healthcare sector address its challenges with workforce deployment, retention and training. At ViVE, the company unveiled which 23 startups have been selected to take part in the accelerator.

Training 101
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Smart Bandage Monitors and Treats Chronic Wounds

Medgadget

Researchers at the California Institute of Technology have developed a smart bandage for chronic wounds, such as those sometimes experienced by patients with diabetes. The bandage is flexible and stretchy, but contains electronic components that can monitor the wound for signs of infection, including abnormal temperature, increased uric acid levels, and changes in pH.

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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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Why Amwell’s CEO Isn’t Completely Discouraged By Its Stock Price

MedCity News

Amwell CEO Roy Schoenberg thinks the stock market has adopted a rather simplistic view of telehealth over the past year, reducing the care modality to a pandemic-era trend in which patients are no longer interested. But Schoenberg pointed out that providers are still committed to virtual care. Because of this, he thinks his company is in a better position to raise its stock price than others because it is partnering directly with providers to evolve telehealth delivery models.

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GSK to exclusively license novel oral antifungal

European Pharmaceutical Review

GSK is set to gain exclusive rights to first-in-class oral antifungal Brexafemme (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) from SCYNEXIS. The exclusive licence agreement will enable GSK to commercialise Brexafemme for VVC and recurrent VVC (RVVC). Currently, the treatment is in Phase III clinical trials for invasive candidiasis (IC).

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GSK Strikes Another Antimicrobial Deal, Paying $90M for Scynexis’s Brexafemme

MedCity News

GSK acquired global rights to Brexafemme, a novel antifungal from Scynexis that is approved for treating vaginal yeast infections. The deal also gives GSK the chance to commercialize the drug in other indications.

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Novel delivery approach demonstrates efficacy of immunotherapy

European Pharmaceutical Review

Intrathecal (IT) (directly into the spinal fluid) and intravenous (IV) nivolumab (anti-PD-1) immunotherapy was found to be safe and improved survival in a subset of melanoma patients with leptomeningeal disease (LMD). The first-in-human, Phase I/Ib study published in Nature Medicine , described the interim analyses of the novel delivery approach. Leptomeningeal disease is a cancer complication that occurs when cancer cells from primary tumours migrate into the cerebrospinal fluid (CSF) and lepto

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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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Ramping Up DSCSA Readiness Efforts

Pharmaceutical Commerce

As a November deadline looms for industry compliance with an interoperable system for product tracing, there is more urgency in the US pharma supply chain.

Pharma 78
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£277m investment to advance UK life sciences manufacturing

European Pharmaceutical Review

A £277 million joint government and industry funding will help four UK life sciences companies to advance life sciences manufacturing projects. The funding is the first tranche of winning grants from the Life Sciences Innovative Manufacturing Fund (LSIMF). £17 million in government funding is supported by additional private investment of £260 million.

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US FDA launches lupus consortium to confront drug development challenges

Pharmaceutical Technology

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Lupus is a potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of colour.

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AlzeCure reveals positive NeuroRestore ACD856 data

PharmaTimes

Therapy is a positive modulator and has demonstrated that it can improve learning and memory

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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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Alzheimer’s drug Leqembi set to generate $12.9bn in sales by 2028

Pharmaceutical Technology

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan. If approved in these regions, it would be established as the top-selling drug for Alzheimer’s disease in the coming years.

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Granular boosts mast cell disease programme

PharmaTimes

Therapy candidates chosen for lead projects targeting mast cell driven diseases

Leads 83
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FDA $7bn plans for 2024: disclose contract manufacturers, restart Cancer Moonshot

Pharmaceutical Technology

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages. The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than

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Predator and prey: Harnessing phages to fight antibiotic resistance

PharmaVoice

Phages, bacteria’s natural predator, could help combat the growing threat of superbugs. But can these therapies rise above antibiotic market woes?

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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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Recommendations for Accelerating Cell and Gene Therapies

PharmExec

While there are many successes to show for its decades of development, there remain four substantial problems that impede the velocity with which cell and gene therapies can be brought to market. Despite the intricacies of these issues, there are emerging solutions to address them. If the biopharma industry can develop these solutions on a broad scale, cell and gene technologies can accelerate and fulfill the early promise of regenerative medicine.

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Digital biomarkers lay the groundwork for precision medicine beyond the bloodwork

PharmaVoice

Biomarkers are the hidden talent behind precision medicine, and finding them doesn't have to always come from a blood test — digital pioneers are finding another way.

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Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA

Pharma Leaders

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

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Repurposing Drugs: How One Doctor Saved His Own Life and Hopes to Save Others

PharmExec

Two companies team up to combat rare diseases through drug repurposing, which was heavily informed by one doctor’s experience through unconventionally treating his Castleman disease and (ultimately) saving his own life.

Doctors 52
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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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How To Find The Best Medical Staffing Agency

Rep-Lite

Finding a medical staffing agency that meets your needs can be a daunting process. At Rep-Lite, we understand the challenges healthcare organizations face when it comes to obtaining qualified personnel and are committed to providing exceptional service to each of our clients. Our team of experienced professionals has decades of experience in recruiting, hiring, training and managing personnel for hospitals, clinics, nursing homes and other healthcare facilities.

Medical 52
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Overcoming key barriers to accelerate digital engagement for pharmaceutical organizations

Veeva

Digital solutions have become a core focus in the pharmaceuticals and life sciences industry in recent years, with pharmaceutical organizations increasingly keen on alternative ways to communicate and engage with healthcare professionals (HCPs). According to the latest Veeva Pulse Field Trends Report , digital engagement resulted in 67% more HCP meetings for sales reps in APAC.

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Ad Astra Diagnostics Files 510(k) for QScout™ Hematology Analyzer

Legacy MEDSearch

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its QScout RLD rapid-result hematology system intended to report white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six white blood cell types in fingerstick or venous blood.

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FDA tackles opioid crisis with OTC Narcan approval

Pharmaceutical Technology

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. Emergent BioSolutions’ Narcan (naloxone hydrochloride) is a medicine used to reverse opioid-related overdoses. This approval comes at a time when the US is facing a growing opioid crisis. The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms.

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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.