June, 2024

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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What Hospitals Need to Know about Patient Trust in GenAI

MedCity News

Hospitals need to start thinking about ways to build patients’ trust in generative AI in order for the healthcare industry to fully harness the technology’s potential. They can do this through methods like having transparent conversations, asking for patients’ consent to use the tools and training models on internal data, experts said. The post What Hospitals Need to Know about Patient Trust in GenAI 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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How to Increase Sales in a Medical Field

David Bagga

Medical Device Sales Academy How to Increase Sales in a Medical Field Here are some of the ways that contribute towards increasing medical sales: 1. Get in-depth Product Knowledge A thorough understanding of your products is crucial in medical deals. This includes the technical specifications, clinical applications, and benefits. Attend training sessions, read product manuals, […] The post How to Increase Sales in a Medical Field appeared first on.

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The tactical trap in pharma CX – and how to avoid it

Dominic Tyer

Customer experience (CX) is not a new discipline for pharma, but it does continue to provide the industry with growing pains

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More Trending

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement

MedCity News

Two senators recently introduced a bill that seeks to regulate private equity firms’ involvement in the healthcare industry. If passed, the act would establish a criminal penalty of up to six years in prison for private equity executives whose business decisions result in a patient’s death. The post If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement appeared first on MedCity News.

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6 Steps for Success in the Medical Sales Field

David Bagga

Medical Device Sales Academy 6 Steps for Success in the Medical Sales Field The medical representative works to deliver the company’s ideas and messages to the healthcare reps in the most efficient, understandable, and intelligible way. The best way to help improve their service is to provide all necessary information, equipment, and opportunities to enhance […] The post 6 Steps for Success in the Medical Sales Field appeared first on.

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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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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’

PharmaVoice

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

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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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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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

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Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In

MedCity News

Multiple stakeholders are to blame for prescription drug costs, including pharmaceutical companies and PBMs, according to Merith Basey, executive director of Patients for Affordable Drugs. The post Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In appeared first on MedCity News.

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Top 10 Medical Sales Training Programs To Grow Your Career

David Bagga

Medical Device Sales Academy Top 10 Medical Sales Training Programs To Grow Your Career Following a career in medical sales can be both challenging and rewarding. Investing in a sales course is vital to gaining insight into the field. These programs are essential for building and maximizing your success and growth potential. This article will […] The post Top 10 Medical Sales Training Programs To Grow Your Career appeared first on.

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New polymer-based drug delivery system developed for tuberculosis

European Pharmaceutical Review

Researchers have reported the successful formulation of clofazimine spray-dried poly (lactic acid-co-glycolic acid) (PLGA) microparticles as an “efficient” treatment for tuberculosis (TB). In treating this bacterial infection, the paper highlighted that oral therapy often fails to achieve therapeutic concentrations at the primary infection site, the lungs.

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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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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Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults

Fierce Pharma

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

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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.

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Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment

MedCity News

Physical and mental health are inextricably intertwined — senior-focused primary care can help bridge the treatment gap The post Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment appeared first on MedCity News.

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7 Reasons To Choose The Medical Sales Field

David Bagga

Medical Device Sales Academy 7 Reasons To Choose The Medical Sales Field If you are considering a new career path or career change in the medical field, this post is for you. The blog could be what you’ve been looking for in Medical software sales. This exciting and profitable field pays well, is secure, and […] The post 7 Reasons To Choose The Medical Sales Field appeared first on.

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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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New study reveals how brain cell communication is linked to Alzheimer’s disease

PharmaTimes

Two support cells, microglia and astrocytes, were found to communicate with each other

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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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BMS chief Boerner says company is still hungry for deals after spending more than $20B on M&A last year

Fierce Pharma

As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.

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Ahead of its upcoming decision date, a competitor takes aim at KarXT

PharmaVoice

The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.

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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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Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians

MedCity News

What if working with independent contractor physicians is the key to unlocking a more stable sustainable healthcare workforce? The post Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians 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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New paediatric blood test to prevent sudden death from hereditary heart condition

PharmaTimes

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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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