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 113
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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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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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Regulation and legislation in the era of automation and digitalisation

European Pharmaceutical Review

Friend or foe? Pharmaceutical companies ask themselves this question before embracing the latest technologies because every innovation comes with both opportunities and risks. Today, technological advancements in artificial intelligence (AI), machine learning (ML), digitalisation, and robotic manufacturing automation solutions stand to revolutionise R&D, clinical trials, and manufacturing in the pharmaceutical industry.

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

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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.

FDA 115
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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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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

Medicine 111
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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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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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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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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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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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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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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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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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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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Scott Burrows: Empowering Financial Advisors with Vision and Resilience

Scott Burrows

In my journey as a keynote motivational speaker within the financial services industry, I’ve had the privilege of addressing esteemed organizations such as Merrill Lynch, Janney Montgomery, Morgan Stanley, Met Life, Farmers and Edward Jones, among others. Through these engagements, I’ve shared my life-transforming story and principles of success anchored in Vision, Mindset, and Grit.

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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 115
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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.

Patients 307
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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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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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First-in-class telomerase inhibitor approved for blood cancer

European Pharmaceutical Review

The first telomerase inhibitor has been approved by the US Food and Drug Administration (FDA). RYTELO ( imetelstat ) is authorised for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia. The first-in-class oligonucleotide telomerase inhibitor is indicated for these patients who need four or more red blood cell units over eight weeks, who are unresponsive to or ineligible for erythropoiesis-stimulating agents (ESA).

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Bayer taps Samsung wearables for menopause sleep study

pharmaphorum

Sleep disturbances are one of the most common and disruptive symptoms in menopausal women, but not enough is known about the causes, and current sleep aids are often ineffective. To plug that gap, Germany’s Bayer has joined forces with electronics group Samsung to carry out an observational study on sleep disturbances during menopause (SDM), tapping into the South Korean company’s position as one of the world's largest producers of consumer electronics.

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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.

Biopharma 307
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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

Ethics 98
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ASCO: Moderna may file melanoma vaccine on phase 2b data

pharmaphorum

New data from a phase 2b trial of Moderna and MSD’s neoantigen melanoma vaccine may be strong enough to consider filing for accelerated approval before a phase 3 programme.

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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.

Biopharma 301
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Another Retailer Bites the Dust. Is There Still Hope for Retailers After Dollar General/DocGo End Pilot?

MedCity News

Dollar General and DocGo have mutually decided to end their mobile clinic pilot. The decision comes as numerous retailers have struggled in the healthcare sector. The post Another Retailer Bites the Dust. Is There Still Hope for Retailers After Dollar General/DocGo End Pilot? appeared first on MedCity News.

Retail 110
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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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Combination therapy may hold potential for severe viral hepatitis

European Pharmaceutical Review

Final Phase IIb data has confirmed the potential of bulevirtide 10mg in combination with pegylated interferon alfa-2a (PegIFN) as a finite therapy for adults with chronic hepatitis delta virus (HDV), according to Gilead Sciences. The new data is from the MYR204 study which investigated the efficacy and safety of the first-in-class entry inhibitor bulevirtide alone and together with PegIFN, in these patients with compensated chronic HDV infection.

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Gilead, Ipsen build the case for their PBC drugs at EASL

pharmaphorum

Gilead Sciences is just a few weeks away from an FDA decision on seladelpar for rare liver disease primary biliary cholangitis (PBC) and will be buoyed by new data pointing to its long-term efficacy and safety.

Safety 107
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ASCO: With Opdivo-Yervoy combo, Bristol Myers calls Roche and AstraZeneca's bets in first-line liver cancer

Fierce Pharma

Following fellow immunotherapy regimens by Roche and AstraZeneca, Bristol Myers Squibb’s Opdivo and Yervoy want to carve out a piece of the first-line liver cancer market, too. | Following fellow immunotherapy regimens by Roche and AstraZeneca, Bristol Myers Squibb’s Opdivo and Yervoy want to carve out a piece of the first-line liver cancer market, too.

Marketing 295
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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.

Medical 107
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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.