Sat.Jun 15, 2024 - Fri.Jun 21, 2024

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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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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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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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Journal Citation Reports 2024: Simplifying journal evaluation

Clarivate

Consolidated categories and unified rankings enable you to explore and compare journals more easily. Today we announce the 2024 release of the annual Journal Citation Reports (JCR ), which marks the completion of a series of significant changes we’ve implemented in recent years. This blog will take you through what to expect in the application. Last year’s release expanded the Journal Impact Factor (JIF ) to all journals in the Web of Science Core Collection and moved to display the JIF to one d

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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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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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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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Blood test could spot Parkinson’s years earlier

pharmaphorum

An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments

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FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

MedCity News

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top biologics official, reviewed the same data and reached a different conclusion. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

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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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Top 10 Medical Education Trends of 2024

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The days of cookie-cutter medical education sessions and unengaging, didactic data presentations are–mostly–over. These days, medical education and training programs are all about customization, personalization, and innovation. In this article, we take a look at 10 of the hottest trends in medical education and learning programs. 1.

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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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Semi-automation of manual interventions in high-speed filling lines

European Pharmaceutical Review

Researchers have developed a novel, gloveless intervention method with remote robotic interventions for high-speed pharmaceutical isolator filling lines. While these high-speed lines are currently fully automated, Dekker et al. noted that operator interventions are still done manually. For example, a common intervention is the removal of erroneous plungers or stoppers.

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Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study

MedCity News

Palliative care provided by video was equivalent to in-person visits with a clinician, according to study results presented during the recent annual meeting of the American Society of Clinical Oncology. Investigators say these results indicate telehealth can make palliative care accessible to more cancer patients. The post Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study appeared first on MedCity News.

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In fight against knockoff weight loss meds, Eli Lilly accuses sellers of 'deceptive' advertising

Fierce Pharma

Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.

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FDA says yes to MSD’s 21-valent adult pneumococcal jab

pharmaphorum

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

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

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Gilead small molecule demonstrates strong capability for HIV prevention

European Pharmaceutical Review

Gilead Sciences ’ twice-yearly injectable HIV-1 capsid inhibitor enabled 100 percent efficacy for investigational use of HIV prevention in cisgender women. This is according to interim analysis topline results of the Phase III PURPOSE 1 trial. Lenacapavir showed superiority to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

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Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage

MedCity News

Under the Affordable Care Act, most private health insurance plans are required to cover birth control methods approved by the FDA without out-of-pocket costs. But not all plans are doing this, Bernie Sanders declared in a letter. The post Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage appeared first on MedCity News.

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Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Fierce Pharma

There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

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Embracing Challenges: The Power of “What” Questions

Scott Burrows

In the dynamic world of business, how we approach challenges can define our path to success. Instead of being bogged down by adversity, we have the power to transform it into opportunity simply by changing the way we ask questions. From “Why” to “What” During tough times, it’s natural to ask ourselves, “Why is this happening to us?

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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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Big potential for small molecule drugs in cancer treatment

European Pharmaceutical Review

Small molecule drugs have been a critical part of the pharmaceutical toolbox for over a century. Most can be taken orally and pass through cell membranes to reach intercellular targets, however, recent advancements in areas such as AI and machine learning have seen the potential for new small molecule-based therapeutics grow exponentially. One example of this is Takeda’s small molecule drug, fruquintinib, which has been shown to be an effective treatment for heavily pretreated metastatic colorec

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Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare

MedCity News

During a fireside chat at AHIP 2024, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, said she sees a bright future for retail in healthcare. The post Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare appeared first on MedCity News.

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AstraZeneca's Truqap misses the mark in late-stage triple-negative breast cancer trial

Fierce Pharma

While AstraZeneca’s Truqap bears the distinction of being the first AKT inhibitor to pass muster with the U.S. | In the late-stage CAPItello-290 study, Truqap plus the chemotherapy paclitaxel failed to help extend the lives of patients with locally advanced or metastatic triple-negative breast cancer (TNBC) over paclitaxel and placebo alone, AstraZeneca said Tuesday.

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Johnson & Johnson submits BLA to FDA for lung cancer drug

Pharmaceutical Technology

Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.

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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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Non-chemotherapy lymphoma treatment may provide durable remission

European Pharmaceutical Review

A non-chemotherapy multi-drug therapy enabled complete remission in 38 percent of evaluable patients with aggressive B-cell lymphoma, a Phase Ib/II clinical trial shows. This was observed in individuals who had experienced a return of their cancer or who were unresponsive to standard treatments. Venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR) were used together in a treatment regimen in 50 patients with diffuse large B-cell lymphoma (DLBCL).

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Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks

MedCity News

A proactive cybersecurity stance can maintain the integrity of healthcare, ensuring that care remains both continuous and secure. The post Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks appeared first on MedCity News.

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J&J's subcutaneous version of Tremfya excels in Crohn's disease study

Fierce Pharma

In May, Johnson & Johnson touted the success of its intraven | After touting the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease, Johnson & Johnson has shown the success of a subcutaneous (SC) version of Tremfya in another Crohn's disease study.

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AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

pharmaphorum

AbbVie’s Skyrizi is approved by the FDA for ulcerative colitis, making it the first IL-23 inhibitor indicated for both major types of inflammatory bowel disease.

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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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J&J commits five-year investment in Italian medicine manufacturing

European Pharmaceutical Review

Johnson & Johnson Innovative Medicine is planning to invest a total of €580 million in Italy over the next five years. A portion of the investment, €125 million, is intended to support greater production capacity at its Latina site, which is a key part of the firm’s worldwide supply chain network, the company stated. For example, the plant produces over four billion tablets every year, spanning approximately 30 different products, J&J confirmed.

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Talkiatry Raises $130M To Expand Behavioral Health Access

MedCity News

Talkiatry’s funding round was led by Andreessen Horowitz. With the financing, the company will bring on more providers and advance value-based care. The post Talkiatry Raises $130M To Expand Behavioral Health Access appeared first on MedCity News.

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From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

Fierce Pharma

Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all. | Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

PharmaVoice

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time