Sat.Jun 01, 2024 - Fri.Jun 07, 2024

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Abbott’s OTC glucose monitor ‘will grow the market’

pharmaphorum

Just a few weeks after Dexcom’s Stelo became the first over-the-counter continuous glucose monitor (CGM) to be approved by the FDA, Abbott has got the green light for its Lingo device - and analysts think uptake by patients is now poised to take off.

Marketing 101
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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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SCOTUS Deals a Blow to Medical Debt Collectors

MedCity News

The Consumer Financial Protection Bureau, which has been targeting debt collection practices, survives a Supreme Court challenge. The post SCOTUS Deals a Blow to Medical Debt Collectors appeared first on MedCity News.

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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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

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Regenerative cell therapy biotech uses IPO to blast into human trials

PharmaVoice

Bucking conventional fundraising, FibroBiologics’ CEO Pete O’Heeron explains why the biotech company bet on themselves in the public market.

Marketing 119
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Bristol Myers puts more than 860 jobs on chopping block in NJ as $1.5B savings campaign rolls ahead

Fierce Pharma

The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.

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INVEST Pitch Perfect Spotlight: How One Company Aims To Change Neonatal Feeding

MedCity News

Mother’s Milk Is Best has a medical device that increases the ability to use a mother’s milk or a donor’s milk versus other fortification processes. Last month, judges selected the company as the winner of the consumer/employer track of MedCity News’ INVEST Pitch Perfect contest. The post INVEST Pitch Perfect Spotlight: How One Company Aims To Change Neonatal Feeding appeared first on MedCity News.

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First rare disease therapies chosen for FDA START programme

pharmaphorum

An initiative set up by the FDA to accelerate the development of therapies for rare disease in the same way that Operation Warp Speed delivered COVID-19 vaccine has chosen its first pilot programme candidates.

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Lilly wins NICE endorsement for tirzepatide in obesity—with a catch

Fierce Pharma

A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has retu | A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has returned with an endorsement in obesity.

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Scott Burrows: Inspiring Franchise Business Speaker

Scott Burrows

In my journey as a keynote speaker within the franchise industry, I’ve had the honor of addressing numerous esteemed franchises, including Two Men and a Truck, Dunn Brothers Coffee, Expedia Cruise Ship Franchise Industry, Snap Fitness, the Conklin Companies, Screen Mobile, and many others. Through these engagements, I’ve shared my life-changing story and principles of success centered around Vision, Mindset, and Grit.

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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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Collaboration is Vital to Creating Inclusive Healthcare Technologies

MedCity News

The large-scale, multidisciplinary effort to improve the performance of pulse oximeters provides an example of the value of collaboration to solve problems and shows how industry partners can contribute in a significant way when they have a seat at the table. The post Collaboration is Vital to Creating Inclusive Healthcare Technologies appeared first on MedCity News.

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ASCO: KRAS upstarts set their sights on NSCLC market

pharmaphorum

KRAS inhibitors from Eli Lilly, Genfleet, and InxMed make their case for use in NSCLC at ASCO, as they case down Amgen and Bristol-Myers Squibb's market drugs

Marketing 107
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ASCO: AstraZeneca, Daiichi's Enhertu looks to make history again in HER2-ultralow breast cancer

Fierce Pharma

After Enhertu pioneered the HER2-low category in breast cancer treatment, AstraZeneca and Daiichi Sankyo are now hopeful that the antibody-drug conjugate can reach tumors with an even lower express | After Enhertu pioneered the HER2-low category in breast cancer treatment, AstraZeneca and Daiichi Sankyo are now hopeful that the antibody-drug conjugate can reach tumors with an even lower expression of the protein biomarker.

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CCC Helps Establish Leiden Institute for FAIR and Equitable Science (LIFES) as a Founding Member

Copyright Clearance Center

June 5, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announced its collaboration with key industry stakeholders to launch the Leiden Institute for FAIR and Equitable Science (LIFES). In recognition of the challenges that exist with data reuse within the global research community, LIFES is a joint effort by an international public-private partnership of eleven academic and private organizations to build a wide and diverse network

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Zeto Receives FDA Clearance for Its User-Friendly EEG Brain Monitoring System

MedCity News

Medical device company Zeto received clearance for its EEG brain monitoring system. The system includes a user-friendly, comfortable EEG headset designed to be easily operated by any medical professional with minimal training. The post Zeto Receives FDA Clearance for Its User-Friendly EEG Brain Monitoring System appeared first on MedCity News.

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ASCO: Conversational AI tackles missed colonoscopies

pharmaphorum

An AI tool has shown impressive results in raising colorectal cancer screening rates in underserved populations, according to data presented at ASCO

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ASCO: AstraZeneca's Tagrisso, Imfinzi break new ground in lung cancer—with one standing ovation

Fierce Pharma

A 50% improvement on the time patients could live without disease progression would typically be considered remarkable for a new drug. AstraZeneca’s Tagrisso just delivered an 84% improvement. | A 50% improvement on the time patients could live without disease progression would typically be considered remarkable for a new drug. AstraZeneca’s Tagrisso just delivered an 84% and earned a standing ovation at ASCO 2024.

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Exploring the Potential of mRNA (BIO 2024)

PharmaTech

Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.

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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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How Testosterone is Revolutionizing Menopause Care

MedCity News

Shedding light on misconceptions about testosterone and women’s health The post How Testosterone is Revolutionizing Menopause Care appeared first on MedCity News.

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Climate change may aggravate multiple sclerosis

Pharmaceutical Technology

A June 2024 literature review has revealed that climate change has the potential to intensify MS symptoms, as well as the incidence, prevalence, and severity of other major neurological disorders.

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Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China

Fierce Pharma

For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party (CCP) has continued to gain steam. | For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party has continued to gain steam. Now, several new names could be feeling the heat.

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Buoyed by new obesity data, Structure files $476m offering

pharmaphorum

Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Preventative Care: The Right Approach to Improving Endpoint Security

MedCity News

While firewalls, network monitoring and other security practices are imperative, it pays to give more thought to how to better secure endpoint computing. The post Preventative Care: The Right Approach to Improving Endpoint Security appeared first on MedCity News.

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Data needed to forge the link between AI and mRNA

Pharmaceutical Technology

While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.

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Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?

Fierce Pharma

On the eve of the American Society of Clinical Oncology’s annual meeting last week, a piece of news set off vigorous discussions. | After Akeso and Summit's ivonescimab beat Keytruda in a head-to-head trial in non-small cell lung cancer, analysts are trying to sort out the financial ramifications while biopharma insiders are eager to see the exact data.

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Mexican man dies in first human case of H5N2 bird flu

pharmaphorum

A man in Mexico has died in what the WHO has said is the first lab-confirmed human infection with the H5N2 strain of bird flu

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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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Why the Cyberattack on Ascension Scared 5 Hospital Execs & How They’re Responding

MedCity News

As majorly disruptive cyberattacks continue to make headlines in the healthcare world, hospitals are prioritizing cybersecurity more than ever before. This piece explores reactions from five different health system executives about the recent attack on Ascension — as well as what they’re doing to prevent a similar fate at their own organization and how they want things to change going forward.

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GSK shares fall 9% in wake of Zantac court ruling

Pharmaceutical Technology

Monday saw a 9% drop in GlaxoSmithKline’s (GSK) share price on the London Stock Exchange (LSE) following a Delaware judge’s ruling on 31 May that over 72,000 lawsuits over discontinued heartburn drug Zantac, known generically as ranitidine, could go ahead.

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FDA cracks down on China's Hengrui in scathing manufacturing write-up

Fierce Pharma

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.

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The Intersection of Chemistry, Robotics, and AI in Drug Discovery (BIO 2024)

PharmaTech

Lee Cronin, founder and CEO of Chemify, discusses the combination of digital chemistry, robotics, and AI in the drug discovery space.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.