Sat.Jan 14, 2023 - Fri.Jan 20, 2023

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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After ‘limping along,’ Novavax sees a path forward

PharmaVoice

With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

Vaccines 274
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Celadon receives good manufacturing practice approval

Pharma Times

MHRA approval relates to the company’s midlands-based drug development facilities

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FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults. Rykindo ® is an atypical antipsychotic developed by Luye Pharmaceutical.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

STAT

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

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More Trending

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AbbVie and Eli Lilly snub drug pricing agreement

Pharma Times

Major industry names depart leaving UK pricing deal in serious jeopardy

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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A new study links social media use to changes in teen brains. Is that a bad thing?

STAT

Today’s teens and tweens have never known a world without social media. There are still a lot of open questions about how sites like TikTok and Instagram may shape their development — and stories focusing on the potential negative impacts of social media tend to dominate the news. But a recent study published in JAMA Pediatrics is the latest in a growing body of research that suggests the relationship that young people have with social media is too complicated to be categorized as

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The M&A hunt is on — here are the prime targets

PharmaVoice

Companies with advanced molecular therapies, oncology assets and obesity treatments could be fuel for a dealmaking fire this year.

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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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Scottish Medicines Consortium recommends Merck’s Tepmetko

Pharma Times

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

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WTAS: Inflation Reduction Act already impacting R&D decisions

PhRMA

The Inflation Reduction Act’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical research & development (R&D) decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA’s price setting provisions are a loss for patients everywhere.

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The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond

STAT

Increased injection drug use has led to a spike in cases of the life-threatening heart condition endocarditis , with cases rapidly accelerating since the onset of Covid-19. The increased case count is one of the lesser-known side effects of the deadly addiction epidemic. But patients with endocarditis, an inflammation of the heart lining caused by infection, require complex, thoughtful care — care that the U.S. health system is ill-equipped to provide.

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Pro sports’ COVID protocols led to real-world data impacts for pharma

PharmaVoice

After years of pioneering new methods for using data and technology to improve patient health outcomes, IQVIA’s Christina Mack is on the cusp of a research revolution.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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NHS Confederation very concerned by latest industrial action

Pharma Times

Unrelenting pressure caused by strikes, flu and COVID-19 may be keeping NHS in vicious cycle

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CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

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STAT+: Moderna says RSV vaccine worked, setting stage for competition with GSK and Pfizer

STAT

Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.

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UBC crowns Bekki Brown as its new CEO with a clear mandate to grow

PharmaVoice

The first-time CEO is tapping into decades of operational expertise to help bring real-world data into the mainstream.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Stada and Xbrane receive approval for Ximluci

Pharma Times

Biosimilar gains MHRA marketing authorisation for use throughout Britain

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UK medical cannabis manufacturer granted GMP registration

European Pharmaceutical Review

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing.

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In the search for therapies for solid tumors, companies are turning to a novel target: claudin-6

STAT

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from the new STAT Report : Targeting cancer: the new frontier of immunotherapy and precision oncology. Targeted immunotherapies like CAR-T have been remarkably successful in combating blood cancers like chronic lymphocytic leukemia.

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Woman of the Week: Genetika+’s Talia Cohen Solal

PharmaVoice

The CEO is aiming to build a “brain-in-a-dish” to treat all patients for better mental health outcomes.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Amvuttra recommended by NICE for amyloidosis

Pharma Times

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

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UK ATMP clinical trials report 2022 published

European Pharmaceutical Review

The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’. In the data, T cells were revealed as the most commonly investigated cell type continuing to increase. The research observed this cell type took up 58 percent of UK ATMP clinical trials in 2022. . Matthew Durdy, Chief Executive of CGT Catapult commented: “It is encouraging to see continued growth of UK clinical trial activity, demonstrating the UK as a favoura

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Mental health benefits of gender-affirming hormones for teens persist for two years in new study

STAT

Trans and nonbinary teenagers who receive gender-affirming hormones experience less depression and anxiety and more satisfaction with life than before the treatment, according to a new study published Wednesday in the New England Journal of Medicine. Researchers followed over 300 adolescents across the U.S. for two years after initiating hormone treatment.

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A Moderna tie-up ushers in new era for CytomX

PharmaVoice

The antibody-focused company followed up a tough year with big partnerships to keep the ball rolling.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.