Fri.Jul 26, 2024

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Eisai and Biogen's Alzheimer's med Leqembi turned down in Europe

Fierce Pharma

Despite winning approvals in a range of countries like the U.S., China, Japan and Israel, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European r | Despite winning approvals in a range of countries like the U.S., China and Japan, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European regulators.

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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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Trending Sources

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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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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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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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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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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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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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GSK blows Jemperli marching brass against Keytruda with expanded FDA nod in endometrial cancer

Fierce Pharma

Merely a month into an FDA approval for a broad first-line endometrial cancer population, Merck’s Keytruda has some company. | Merely a month into an FDA approval for a broad first-line endometrial cancer population, Merck’s Keytruda has some company in the form of a matching go-ahead by GSK's Jemperli.

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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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Europe's CHMP endorses clutch of new medicines including Astellas, J&J and Ipsen offerings

Fierce Pharma

While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions. | While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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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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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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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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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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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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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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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New gut microbiome atlas could offer better treatment for digestive disorders

PharmaTimes

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR

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

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Pharma Pulse 7/26/24: Talent Management Strategies for Post-Milestone Growth, Dispensing Medication for Muslims & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Pfizer's haemophilia B gene therapy gets EU green light

pharmaphorum

Pfizer's haemophilia B gene therapy is approved in EU as Durveqtix, becoming the first alternative to CSL Behring's Hemgenix

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EC conditionally approves Pfizer’s haemophilia B gene therapy

Pharmaceutical Technology

The European Commission has awarded conditional marketing authorisation for Pfizer's DURVEQTIX for haemophilia B treatment.

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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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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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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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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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Beyond Assumptions: How Leaders Shape Employee Experience

ALULA

Leaders everywhere are talking about Employee Experience, and for good reason. EX is perhaps the single most important thing an employer can do to improve engagement, productivity, and retention.

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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

Food 52
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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