Sat.Jul 30, 2022 - Fri.Aug 05, 2022

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Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work?

PharmaVoice

Companies like Cost Plus Drugs and DiRx can bring generics directly to consumers at a fraction of the price, but whether it’s enough to fix the inflated U.S. healthcare system is yet to be seen.

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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.

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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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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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A glimpse inside Bristol Myers Squibb’s integration with Celgene

PharmaVoice

Catherine Owen, senior vice president of major markets, discusses the hurdles — and successes — of bringing the two ‘powerhouses’ together.

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Pharmacopoeias to further support vaccine development and supply

European Pharmaceutical Review

Ph. Eur. The European Pharmacopoeia (Ph. Eur.) Commission has established the mRNAVAC Working Party to begin working on quality standards to support the emerging field of messenger RNA (mRNA) vaccines. The newly created Working Party’s first task will be to develop a consolidated strategy for future standards addressing these vaccines and their components.

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More Trending

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Sarepta says early filing for DMD gene therapy is back on

pharmaphorum

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023. The US biotech – which already has three antisense drugs for DMD on the market – had said earlier it was planning to delay the application into 2023, so the new announcement marks an acceleration of its plans.

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Taking probiotics where they’ve never gone before

PharmaVoice

How Seed Health is transforming the microbiome therapeutic market with its pharma-focused drug development approach.

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Microparticles could form self-boosting vaccines

European Pharmaceutical Review

Researchers have developed microparticles that can be tuned to deliver their payload at different time points. According to the authors, the technology could enable the creation of “self-boosting” vaccines that only need to be administered once, which could be particularly beneficial for childhood vaccinations in regions with limited access to medical care.

Vaccines 105
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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

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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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Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

pharmaphorum

Roche’s Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial. The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

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How a speech analysis tool could transform diagnosis and research for Alzheimer’s and beyond

PharmaVoice

WinterLight’s machine learning platform assesses speech to more accurately identify neurodegenerative diseases.

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Big Data Steering Group to enhance data quality and discoverability under new workplan

European Pharmaceutical Review

The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025. According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. “Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes an

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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

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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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How the WHO hepatitis strategy measures up in the field

pharmaphorum

According to the World Health Organization (WHO), approximately 296 million people globally live with hepatitis B, with most unaware of their infection. Africa is the worst impacted region for hepatitis B with a prevalence of 7.5 percent compared to 0.5 percent in the Americas. Hepatitis C impacts an estimated 58 million people across the globe. Again, Africa is the worst-impacted region with a prevalence of 0.8 percent while the Americas see a prevalence of 0.5 percent.

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‘Death by 1,000 cuts:’ How emerging tech could change the journey for ALS patients

PharmaVoice

EverythingALS aims to speed drug development through improved diagnostics.

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L9LS antibody safe and highly protective against malaria, finds study

European Pharmaceutical Review

A single injection of the investigational L9LS monoclonal antibody (mAb) has been found to be safe and highly protective in US adults exposed to the malaria parasite. The results of the Phase I US National Institutes of Health (NIH) study were published in The New England Journal of Medicine. In 2020, the World Health Organization (WHO) estimated that 240 million people had malaria, the mosquito-borne disease spread by Plasmodium parasites, and that it caused about 627,000 deaths.

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Vaccine Administration: The Growing Role of Prefilled Syringes

PharmaTech

The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.

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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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Bayer tops pharma rankings for diversity, inclusivity

pharmaphorum

The largest pharma companies have all set themselves ambitious targets in recent years to improve representation for women and minority communities in their businesses, but are they meeting those diversity objectives? On the whole, yes, says a new study by reputation intelligence and media monitoring specialist alva , which delves through millions of content items across online and traditional media and other source materials to give a score on their diversity, equity and inclusion (DE&I) ef

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Editas, Real Chemistry and Compass blaze new trails with pivotal C-suite hires

PharmaVoice

How these latest executive personnel changes are impacting the industry.

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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

European Pharmaceutical Review

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. The Class 1 Medicines Recall Notification was published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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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.

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Gilead Sciences’ push into oncology is paying off, as Veklury falters

pharmaphorum

Gilead Sciences’ investment in oncology has started to provide a solid return, with sales of cancer therapies breaching the $500 million threshold for the first time in the second quarter. Cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) for lymphoma and leukaemia together brought in $368 million, up 68%, while antibody drug conjugate Trodelvy (sacituzumab govitecan) rose 79% to $159 million thanks to increased uptake in triple-negative breast canc

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Woman of the Week: Alloy Therapeutics’ Heather Schwoebel

PharmaVoice

The CBO and COO is leaning on her experience navigating the unknown to turn Alloy into an innovation multiplier.

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ViiV agrees to expand access to long-acting HIV PrEP

European Pharmaceutical Review

ViiV Healthcare and the Medicines Patent Pool (MPP) have signed a new voluntary licensing agreement to increase access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) in least developed, low-income, lower middle-income and Sub-Saharan African countries. Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries, subject to required regulatory approvals be

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-h

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Blending human knowhow, artificial intelligence aids drug discovery

Outsourcing Pharma

A leader from pharmaceutical firm Astellas discusses how the company has put to use a discovery platform that combines human expertise, AI, and robotics.

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Litifilimab reduces skin disease activity in CLE trial

European Pharmaceutical Review

New Phase II data demonstrates that treatment with Biogen’s litifilimab (BIIB059) was superior in reducing skin disease activity of cutaneous lupus erythematosus (CLE) to placebo over a period of 16 weeks. The results of the Phase II LILAC study Part B were published in The New England Journal of Medicine ( NEJM ). CLE, a type of lupus, is a chronic autoimmune skin disease.

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Governments and pharma relationships and implications for antimicrobial resistance

Pharmaceutical Technology

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

Across the economy, several industries have seen a significant increase in staff turnover due to several factors including the COVID-19 pandemic, burnout, and increasing demand for workplace flexibility. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. In particular, for the pharmaceutical industry, these talent shortages bring about a host of difficult challenges.