Mon.Jul 29, 2024

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Alpha Cognition's delayed-release Alzheimer's drug Zunveyl passes muster with FDA

Fierce Pharma

Amid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition. | Amid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition.

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Enabling Clinical Trial Innovation Through AI Regulation at FDA

MedCity News

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

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With multi-state agreement worth $86M, Indivior moves to resolve more opioid litigation

Fierce Pharma

Suboxone maker Indivior has spent years dealing with allegations related to its role in the United States opioid epidemic, inking several settlements over that span and even witnessing its former C | More than a dozen states linked up on the agreement after accusing Indivior of fueling the opioid epidemic with its opioid addiction treatment Suboxone.

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MedCity FemFwd: The Lack of Research on Chronic Conditions Affecting Women

MedCity News

In this episode, we’re joined by Stacey Missmer, professor and associate chair for epidemiology and translational research at the University of Michigan. She discusses a report she recently co-authored that calls on the NIH to improve research on chronic conditions affecting women. The post MedCity FemFwd: The Lack of Research on Chronic Conditions Affecting Women appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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AstraZeneca trumpets new Calquence combos in CLL. Can they change clinical practice?

Fierce Pharma

With a phase 3 trial win claimed by AstraZeneca, the heated BTK inhibitor race might see its first triplet regimen in chronic lymphocytic leukemia (CLL). | With a phase 3 win claimed by AstraZeneca, the heated BTK inhibitor race might see its first triplet regimen in chronic lymphocytic leukemia.

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UK partnership aims to support NHS use of depression app

pharmaphorum

Otsuka has teamed up with one of the innovation arms of the NHS to explore how a digital therapeutic (DTx) for major depressive disorder (MDD) could be deployed within the health service.The alliance with Health Innovation Oxford & Thames Valley (Oxford HIN) is focusing on Care for MDD, an app-based DTx that has been co-developed by Otsuka and digital health specialist Click Therapeutics.

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GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

MedCity News

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. The post GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines appeared first on MedCity News.

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With new CDC recommendations, RSV market's long-term value falls sharply in US: Airfinity

Fierce Pharma

A month after a CDC panel narrowed its recommendations for RSV vaccines, Airfinity has reduced the projected market size in the US by 64%.

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Does Frequency of a Myalgic Encephalomyelitis/Chronic Fatigue Syndrome-Like Illness Vary Between Those with Differing COVID Test Results?

Pharmaceutical Commerce

A cohort study investigates whether or not the prevalence of these types of illnesses can vary among individuals who are COVID-positive versus negative.

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4 Things to Know About the CrowdStrike IT Outage’s Effect on Healthcare

MedCity News

Hospitals all over the country were affected by the recent IT outage caused by CrowdStrike’s software update. The incident is estimated to have costed Fortune 500 companies in the healthcare sector about $2 billion. The post 4 Things to Know About the CrowdStrike IT Outage’s Effect on Healthcare appeared first on MedCity News.

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

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Bristol Myers Squibb reports dip in net income for Q2 2024

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has posted net income attributable to the company of $1.7bn during Q2 2024, a 19% drop versus $2.1bn in Q2 2023.

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America’s Loneliness Epidemic is Fueling a Mental Health Crisis

MedCity News

America is in the midst of a loneliness epidemic and it’s taking a devastating toll on our mental and physical well-being. Here are 3 things that could help reverse the crisis. The post America’s Loneliness Epidemic is Fueling a Mental Health Crisis appeared first on MedCity News.

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AAIC 2024: the evolution of Alzheimer’s clinical trials

Pharmaceutical Technology

Clinical trial trends point to studying combination therapies and lifestyle changes using alternate designs in Alzheimer’s research.

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Ipsen's Alagille drug backed by CHMP again, with new name

pharmaphorum

Ipsen gets CHMP backing for Alagille syndrome therapy odevixibat, with a new brand name that it hopes will unlock orphan status in the EU

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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What the Ebola Outbreak Reveals about Pandemic Preparedness 

MedCity News

The enduring legacy of the Ebola crisis serves as a poignant reminder of our shared responsibility in safeguarding public health and preventing future pandemics. The post What the Ebola Outbreak Reveals about Pandemic Preparedness appeared first on MedCity News.

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NewAmsterdam obicetrapib data disappoints some investors

pharmaphorum

Shares in NewAmsterdam Pharma were sliding today after it reported a phase 3 trial of obicetrapib that met its primary objective but didn't meet the expectations of some analysts and investors.The BROOKLYN study compared the oral CETP inhibitor to a placebo given on top of maximum tolerated doses of other lipid-modifying therapies, like statins and ezetimibe, in patients with heterozygous familial hypercholesterolaemia (HeFH), a genetic condition that raises blood cholesterol and the risk of hea

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FDA approves Luye Pharma’s ERZOFRI for schizophrenia

Pharmaceutical Technology

The US FDA has granted approval for Luye Pharma’s ERZOFRI extended-release injectable suspension for schizophrenia in adults.

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GSK joins Flagship's flotilla of pharma partners

pharmaphorum

Flagship Pioneering signs another strategic-level deal with a big pharma group, with GSK agreeing an alliance potentially worth more than $7 billion

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Attralus set for amyloidosis asset’s European orphan designations

Pharmaceutical Technology

EMA’s COMP has adopted positive opinions for two orphan medicinal product designations for Attralus’s AT-02.

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NICE blocks Enhertu use after pricing talks break down

pharmaphorum

NICE and pharma groups AstraZeneca and Daiichi Sankyo have been unable to agree on a price for Enhertu in HER2-low breast cancer.

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Study finds 3D-printed blood vessels could improve heart bypass outcomes

PharmaTimes

Coronary heart disease is the most common form of heart and circulatory disease

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Report: MA Beneficiaries Represent Growing Share of Inpatient Hospital Days

MedCity News

A new KFF report detailed the growth in Medicare Advantage’s share of total inpatient hospital days. The post Report: MA Beneficiaries Represent Growing Share of Inpatient Hospital Days appeared first on MedCity News.

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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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FDA Approves Sun Pharma’s Leqselvi for Treating Adults with Severe Alopecia Areata

PharmExec

Leqselvi is classified as a novel oral Janus Kinase inhibitor that targets JAK1 and JAK2 pathways, thought to be involved in the autoimmune response that leads to alopecia areata.

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AMPLIFY results dial up Calquence's potential in CLL

pharmaphorum

AstraZeneca's Calquence hits the mark in the AMPLIFY combination trial in CLL, which could unlock a blockbuster opportunity for the BTK inhibitor

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USP Permits Use of Non-Animal-Derived Reagents for Endotoxin Testing

PharmaTech

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

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Gifts World Expo, at Bharat Mandapam (Pragati Maidan), New Delhi, India – 25 to 27 July 2024

eMediWrite

Gifts World Expo is the largest gifting and promotional solutions exhibition in India. It offers a profitable platform to start-ups and established players in the B2B gifting and promotion sector, as well as to those looking to expand their businesses, find sustainable solutions, generate targeted leads, and accelerate and enhance their value chain.

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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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A holistic approach to safeguard data integrity in Biopharma manufacturing

European Pharmaceutical Review

Integrating robust processes Robust processes are the backbone of any successful operation. They serve as the foundation upon which data integrity is built. In Biopharma, where precision and accuracy are important, integrating robust processes is not just a necessity but a strategic imperative. However, the path to achieve such integration is often filled with unexpected challenges and requires the discovery and understanding of counterintuitive insights.

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FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

PharmExec

Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.

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MIT study reveals how specific cells in AD become vulnerable and resilient

PharmaTimes

The neurodegenerative condition is recognised as the most common form of dementia

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GSK, Flagship Pioneering Collaborate on Novel Medicine Discovery

Pharmaceutical Commerce

The partnership—which features a $150 million investment—is also centered around vaccine development in the respiratory and immunology space.

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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.