Sat.Aug 17, 2024 - Fri.Aug 23, 2024

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An Extra Layer of Transparency and Accountability

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

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Bayer layoffs hit Switzerland with 150 cuts at Basel consumer health hub: reports

Fierce Pharma

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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‘Great on Paper’: Why Primary Care Physicians Are Reluctant To Join Value-Based Care

MedCity News

Many primary care physicians are not participating in value-based payment models. A new study details why and potential solutions. The post ‘Great on Paper’: Why Primary Care Physicians Are Reluctant To Join Value-Based Care appeared first on MedCity News.

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US govt taps Walgreens for decentralised trials

pharmaphorum

Walgreens has signed a $100m contract with the US government's BARDA agency for access to its decentralised clinical trials network

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

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Top 20 biopharmas’ market cap up 4.3% in Q2 2024 as GLP-1 drug innovators hold top spots

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated resilience during the second quarter (Q2) of 2024 as global markets and investor optimism improved with anticipation of a potential interest rate cut from the US Federal Reserve.

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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Study reignites debate on GLP-1 drugs and suicide risk

pharmaphorum

Debate over the safety of GLP-1 drugs resurfaces after study finds 'disproportional' risk of suicidal thinking adverse event reports with Novo Nordisk's semaglutide

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From Adversity to Leadership: Harnessing Resilience and Empowerment Through Keynote to Transform Your Team

Scott Burrows

Keynote Speaking C.W. Driver Annual Meeting at the Discovery Cube in Santa Ana, CA As I’ve talked to many, many leaders through the years, I’ve noticed many similar traits in work styles, life experiences, and mindsets. There was a time when I would have never labeled myself as a leader in any capacity. It wasn’t until I was forced to lead myself to success, that I saw traits of leadership in myself.

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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

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Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

MedCity News

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. The post Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut 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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Medicare plans accuse Teva of covering copays for patients

pharmaphorum

A class action suit has been filed in the US against Teva, claiming that the company illegally subsidised the copays for patients prescribed its multiple sclerosis therapy Copaxone to boost its sales.The suit filed on behalf of Medicare Advantage coverage providers accuses the company of "funnelling hundreds of millions of dollars" to Copaxone (glatiramer acetate) patients through third-party foundations and companies.

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Leadership Behaviors that Drive High-Performance in a Hybrid Workplace

ALULA

Hybrid work continues to impact employees’ preferences, but how does it impact their leaders? In 2021, the World Trend Index reported that 73% of employees wanted flexible remote work options. The latest insights from Gallup show the number dipping only slightly to 60% today. Remote-capable employees are getting what they want , as most are working in a hybrid or exclusively remote arrangement.

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FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

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FDA Clears Gel That Can Stop Bleeding In Seconds

MedCity News

Cresilon snagged its second FDA clearance for human use. The FDA granted 510(k) clearance to Traumagel, the startup’s gel that can stop bleeding in just seconds, for temporary external use to control moderate to severe bleeding. The post FDA Clears Gel That Can Stop Bleeding In Seconds 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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Lilly says tirzepatide staves off diabetes in phase 3 trial

pharmaphorum

Eli Lilly's latest clinical readout for dual GIP/GLP-1 agonist tirzepatide is a big one, with data suggesting the drug can reduce the risk of developing type 2 diabetes in overweight and obese adults with pre-diabetes.There's plenty of evidence to show that prediabetes – a higher-than-normal blood sugar level resulting from a level of insulin resistance that isn't high enough to be considered full-blown diabetes – can be reversed if patients commit to an intensive regimen of dietary restriction

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23andMe inches closes to cancer immunotherapy, guided by its genetic database

PharmaVoice

Dr. Jennifer Low, head of 23andMe’s therapeutics division, is taking the company into new territory with a potential cancer treatment that targets a unique pathway.

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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Why Hospital EDs Are Adopting Cytovale’s Sepsis Test 

MedCity News

A third health system has started using Cytovale’s early sepsis detection test. Froedtert & the Medical College of Wisconsin Health Network announced its plans to deploy the diagnostic test this week. The post Why Hospital EDs Are Adopting Cytovale’s Sepsis Test 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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Expert says supplies of mpox vaccine unlikely to suffice

pharmaphorum

Emergent BioSolutions has agreed to donate 50,000 doses of its mpox vaccine for use in the current outbreak, but an expert has warned supplies are unlikely to meet demand

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Novartis and Versant launch Borealis Biosciences with $150m

Pharmaceutical Technology

Novartis has partnered with Versant Ventures to establish Borealis Biosciences, a Canada based independent, discovery-stage biotech company.

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FDA signs off on Modena, Pfizer/BioNTech's adapted vaccines to corral elusive COVID virus

Fierce Pharma

The FDA has authorized the use of | The FDA has authorized the use of new vaccines from Pfizer/BioNTech and Moderna which have been designed to defend against the Omicron KP.2 variant of SARS-CoV-2. The nod comes as word of a new omicron variant, KP.3.1.1, is beginning to eclipse KP.2 as the dominant strain of the virus in the United States.

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Bipartisan Effort Paves Way for Reviving Shuttered Hospitals in Georgia

MedCity News

The law amends the state’s “certificate of need” system, which allows existing hospitals and other health facilities to block would-be competitors’ plans to expand by arguing there’s insufficient need for their services. The post Bipartisan Effort Paves Way for Reviving Shuttered Hospitals in Georgia appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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J&J's Rybrevant okay challenges Tagrisso in first-line NSCLC

pharmaphorum

J&J's Rybrevant/Lazcluze combination is cleared by FDA for first-line EGFR+ NSCLC, giving AstraZeneca's top-seller Tagrisso its first direct competition

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Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

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Targeting AZ's Tagrisso, Johnson & Johnson's Rybrevant combo wins key FDA nod in first-line lung cancer

Fierce Pharma

A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. | A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. But the real battle against the EGFR king has yet to start.

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Maternal Health Crisis: Lack of Access to Care “Doesn’t Paint the Whole Picture,” Expert Says

MedCity News

The lack of access to quality healthcare is often cited as the reason for maternal health disparities. But these issues go beyond access, according to Bayo Curry-Winchell, MD, founder of Beyond Clinical Walls and urgent care medical director at St. Mary’s Health Network. The post Maternal Health Crisis: Lack of Access to Care “Doesn’t Paint the Whole Picture,” Expert Says appeared first on MedCity News.

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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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New COVID-19 jabs approved by FDA for 2024-25 season

pharmaphorum

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent months.Both new mRNA-based vaccines have been approved for use in people aged 12 and over – and been granted emergency use authorisation for younger people aged 6 months to 11 years – and will be available within the next few days, said the drugmakers.

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Eli Lilly acquires Morphic in IBD portfolio expansion

Pharmaceutical Technology

Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.

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Teva faces fresh Copaxone kickbacks case from Medicare providers as it defends against DOJ claims

Fierce Pharma

For years, Teva has been defending itself against allegations that it used illegal Medicare co-pay schemes to fuel sales of its multiple sclerosis drug Copaxone. | The new lawsuit, filed in a Kansas court, comes as Teva defends against similar allegations made by the U.S. government.

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How Health Systems Can Prepare for the Winter Surge with Virtual Care 

MedCity News

For health systems that are already struggling with capacity and access issues, now is the time to consider specific actions to prepare for this season’s coming surge. The post How Health Systems Can Prepare for the Winter Surge with Virtual Care appeared first on MedCity News.

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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.