Fri.Jul 26, 2024

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J&J's Texas two-step bankruptcy maneuver shut down again by appeals court

Fierce Pharma

Johnson & Johnson’s latest attempt to get a handle on its talc litigation using the controversial Texas two-step bankruptcy strategy has once again fallen flat after a federal appeals court rul | The ruling from the Third Circuit Court of Appeals came the night before claimants in the talc litigation were set to vote on a sweeping $6.48 billion settlement proposal from J&J.

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Revolutionising Drug Discovery: AI Advances with Insilico Medicine's PandaOmics.

Pharma IQ

Discover how AI is transforming drug discovery and the future of AI in pharmaceutical research.

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Bristol Myers CEO 'increasingly confident' company can handle IRA pricing on Eliquis

Fierce Pharma

Amid the sturm und drang over Inflation Reduction Act (IRA) drug price negotiations, Bristol Myers Squibb has been among the biopharma companies casting the most woe over the oncoming measures. | Bristol Myers Squibb CEO Chris Boerner said after seeing the final negotiated price for Eliquis that he is "increasingly confident" the company can navigate the impact of the IRA.

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EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks

MedCity News

The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi. Eisai said it will ask the committee to reconsider the negative opinion. The post EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks appeared first on MedCity News.

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

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Chasing Pfizer and Lilly, Sun Pharma wins FDA nod for alopecia areata med Leqselvi

Fierce Pharma

After Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green ligh | The FDA signed off on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata. The drug is now approved in 8 mg tablets under the brand name Leqselvi.

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GenAI is a Goal but Not the Destination in Healthcare

MedCity News

GenAI will help healthcare reach its destination of efficiency and superior outcomes, but we can’t lose sight of the need for human touch, quality interactions and data to navigate us forward. The post GenAI is a Goal but Not the Destination in Healthcare appeared first on MedCity News.

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Credit Monitoring Won’t Save You: The True Fallout of the Change Healthcare Hack is Just Beginning

MedCity News

The attack has given detailed dossiers on millions of lives to criminals, employers, enemies and anyone with the means and motivation to exploit them. This isn’t just another data breach, it’s a healthcare catastrophe — and it’s being inexplicably downplayed. The post Credit Monitoring Won’t Save You: The True Fallout of the Change Healthcare Hack is Just Beginning appeared first on MedCity News.

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Shingles shot could be a simple way to delay dementia

pharmaphorum

Vaccination with GSK's recombinant shingles vaccine Shingrix could delay the onset of dementia, according to researchers in the UK.A study published in Nature Medicine suggests that people administered Shingrix have a lower risk of dementia compared to those given Zostavax - an older shingles shot based on a different technology – and builds on earlier research suggesting a benefit from this type of vaccination.

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Without the Right Policies, U.S. Risks Inhibiting its Momentum in Healthcare AI  

MedCity News

As other industries confront what some see as a ‘wild west’ in terms of AI adoption, the healthcare industry is already using it, with guardrails in place to protect the patients and healthcare workers who are its customers. To maintain this momentum and not stymie it, policies must be in place that spur continued adoption of this technology. The post Without the Right Policies, U.S.

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Citius’ first FDA decision date is approaching — and its CEO has millions on the line

PharmaVoice

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

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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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Report: Higher-Rated MA Plans Are Less Available in Vulnerable Counties

MedCity News

Disadvantaged counties are less likely to have Medicare Advantage plans with 4.5 stars or higher and more likely to have plans with 3.5 stars or lower, a new study found. The post Report: Higher-Rated MA Plans Are Less Available in Vulnerable Counties appeared first on MedCity News.

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AZ joins call for new UK PM to back Oxford-Cambridge hub

pharmaphorum

Leading figures from industry and academia, including AstraZeneca, have urged UK PM Keir Starmer to turn the Oxford-Cambridge region into the "crown jewel" of his industrial growth plan

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The Power of a Homepage Refresh

Healthcare Success

The Raleigh House, a valued client and marketing partner, had a clear vision: elevate their website's user experience and project an image of luxury and exclusivity. This, they believed, would resonate with their target audience and boost engagement. While a complete website redesign was on the table, we knew we could achieve some "quick wins" first.

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In shock move, EU panel rejects Alzheimer's drug Leqembi

pharmaphorum

CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Maybank is Slowing Down Your Transfer Limit Increases

Contrarian Sales Techniques

What's Happening? Maybank is introducing a new rule that will make it harder for scammers to steal your money. Starting July 31, 2024 , there will be a 12-hour waiting period whenever you ask to increase your online transfer limits. Why is Maybank Doing This? Scammers love to quickly increase transfer limits on your account and then steal your money.

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Meet the 15 Innovative Startups in the HealthTech|X Accelerator, Sponsored by Levo Health

LEVO Health

Levo Health is proud to sponsor Tampa Bay Wave’s 2024 HealthTech|X Accelerator , a rigorous 90-day program that equips high-potential startups with crucial tools for success. David Williams , Levo Health’s Chief Operating Officer & Managing Partner, is serving the Healthtech Advisory Council and will work with and mentor each of the cohort companies during the Accelerator program, contributing his expertise in strategic healthcare marketing.

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Considerations for Planning Effective and Appealing Advisory Boards: Importance of Participant Preferences

Impetus Digital

Pharmaceutical advisory boards and other small-group meetings with health care providers (HCPs) are important for getting feedback on new clinical trial results, competitors’ products, or educational campaigns. However, they are typically expensive and require participants to travel long distances and take time away from their work and families. For in-person meetings, there are also issues with not everyone being able to contribute as much as they want, and the exclusion of people living in rem

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Post-Layoff Success: Employee Experience for the Long Haul

ALULA

It was a perfect storm that threatened a large company’s entire Employee Experience (EX). A major player in the technology sector, this company was facing a restructuring triggered by an acquisition. From the moment the deal was announced, employees knew layoffs were likely.

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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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Navigating Reimbursement Strategies in the Food as Medicine Space

Nixon Gwilt Law

Food as Medicine (FaM), also referred to as ‘Food Is Medicine’ or ‘Food Is Health,’ is playing a significant role in the ever-evolving healthcare landscape. Innovative business models in the FaM space include telehealth-enabled dietitian networks, mobile-ordered meal kits, AI-powered meal plan creators, and integrated nutrition pilot programs. The FaM ecosystem includes stakeholders ranging from dietitians and behavioral support providers focused on chronic conditions, to retail grocery stores a

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FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole with Sertraline for Adults with Post-Traumatic Stress Disorder

PharmExec

The supplemental New Drug Application for brexpiprazole in combination with sertraline is supported by data from three randomized clinical trials that evaluated its safety and efficacy in adult patients with post-traumatic stress disorder.

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Pfizer receives EU haemophilia B gene therapy approval

European Pharmaceutical Review

A conditional marketing authorisation in Europe has been grated for the gene therapy DURVEQTIX ® (fidanacogene elaparvovec), to treat severe and moderately severe haemophilia B (congenital factor IX deficiency) in adults. This new regulatory approval by the European Commission is indicated for patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74.

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What Does it Take to Brew Success?

Scott Burrows

Have you ever had a happenstance that changed your outlook on success and life? This is what happened to me… The Opportunity That Started With a Text Back in 2015, I had a speaking engagement in Barcelona, Spain. As we were leaving the house, my wife and I posted on social media; wishing Miami a goodbye and Barcelona a hello. With the hustle and bustle of the Miami airport, we barely made it to the gate in time.

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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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Fighting the Drop in Vaccination Rates: Q&A with Gregg Sylvester

PharmExec

An unexpected consequence of the COVID 19 pandemic has been a loss in trust of vaccines. Over the past three flu seasons, there has been a drop in vaccination rates that is alarming experts. Dr. Gregg Sylvester, chief health officer at CSL Seqirus, spoke with Pharmaceutical Executive about the causes of the decline and how important it is to get the rates back to normal.

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The Mystery of the Missing Med Info

Contrarian Sales Techniques

I'm a medical sales rep and you guys know it. But today I want to talk about something that hit me outside of work. My buddy John (obviously not his real name) was complaining about these awful knee pains he's been having. He mentioned needing a new pain reliever, but with all the options out there, he was overwhelmed. Have you ever been in that situation?

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Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer

PharmExec

FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.

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Two SpotSee Products Receive AABB Standards Accreditation

PharmaTech

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

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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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Mankind Pharma acquires Bharat Serums and Vaccines for $1.6bn

Pharmaceutical Technology

Mankind Pharma has announced a definitive agreement for the acquisition of Bharat Serums and Vaccines (BSV) for Rs136.3bn ($1.6bn).

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BeiGene Opens New Jersey-Based Biologics Manufacturing and Clinical R&D Site

PharmaTech

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

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Study reveals blood proteins predict risk of developing many diverse diseases

PharmaTimes

Researchers predicted the onset of 67 diseases, out-performing current standard models

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FDA Clears Investigational New Drug Application for Actinium Pharmaceuticals’ Iomab-ACT in Patients with Sickle Cell Disease

PharmExec

The study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.

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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.