Mon.May 29, 2023

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Opinion: More young people should be getting their cholesterol tested and taking statins

STAT

For busy primary care physicians like me, an annual physical with a 27-year-old male is a blessing. Since we’re always running late, a quick visit with a young healthy adult offers the rare chance to get back on schedule. But I didn’t give my own doctor that chance to get back on schedule when I went to see him for my physical a few months ago.

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CHMP meeting highlights – May 2023

European Pharmaceutical Review

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.

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EU approval for Novartis’ sickle cell drug set to be pulled

pharmaphorum

EU approval for Novartis’ sickle cell drug set to be pulled Phil.

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China poised to lead the way with world’s first oral insulin for type 2 diabetes: GlobalData

Express Pharma

Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorisation application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). If approved, China will become the world’s first country with oral insulin availability, says GlobalData. According to GlobalData’s Pharma Intelligence Center, there are only two oral insulins in Phase III globally.

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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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New blood biomarker can predict if cognitively healthy elderly will develop Alzheimer's disease

World Pharma News

Why do some people develop Alzheimer's disease while others don't? And, even more puzzlingly, why do many individuals whose brains are chock-full of toxic amyloid aggregates - a telltale sign of Alzheimer's brain pathology - never go on to develop Alzheimer's-associated dementias? University of Pittsburgh School of Medicine researchers appear to have found the answer.

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Enzene Biosciences launches Cetuximab, biosimilar of cancer drug Erbitux

Express Pharma

Enzene Biosciences has launched Cetuximab as the first biosimilar to cancer. Sold under the brand name Erbitux, Cetuximab is a therapeutic chimeric monoclonal antibody that is used as a targeted therapy for metastatic colorectal cancer (mCRC) and cancer of the head and neck, with eight weeks of treatment costing about $30,000 for a single patient. Enzene’s Cetuximab is produced in Chinese Hamster Ovary (CHO) cell line; resulting in glycosylation profiles that are more human-like.

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Health Canada releases updated Certificate of Supplementary Protection guidance

Pharma in Brief

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices.

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Who’s saying what? Big Data mentions in company filings of pharmaceutical industry decreased by 13% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 13% drop in company filings mentions of big data in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novartis with 185% year-on-year increase, according to GlobalData’s analysis of over 603 pharmaceutical company filings. The big data landscape is rapidly evolving and pharma companies are increasingly integrating big data analytics into their value chains.

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Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

Pharmaceutical Business Review

This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in those patients who are aged 18 years and more. A serious and rare genetic disorder, CDKL5 deficiency disorder (CDD) is characterised by early‑onset, difficult‑to‑control seizures besides severe neuro‑developmental impairment.

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Interactive Case Studies: May 2023

Pharmacy Times

Cases address gastrointestinal issues and alcohol abuse.

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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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Gout!Discover the Symptoms, how to manage naturally, supplements that help, and lifestyle changes.

Welltopia Pharmacy

Do you suffer from Gout symptoms?Is gout negatively affect your daily life?

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Stability of Dry Powder Inhaler Protein Formulations

PharmaTech

Webinar Date/Time: Thu, Jun 15, 2023 11:00 AM EDT

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Which pharmaceutical companies have the most SPCs in Spain?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Spain. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Spain? appeared first on DrugPatentWatch - Make Better Decisions.

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Revolutionizing Solid Production: Unleashing Agility in Granulation Systems

PharmaTech

Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids.

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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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Drug Patent Expirations for the Week of May 28, 2023

Drug Patent Watch

NUZYRA (omadacycline tosylate) Paratek pharms inc Patent: 7,553,828 Expiration: Jun 2, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of May 28, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Who’s saying what? Blockchain mentions in company filings of pharmaceutical industry increased by 17% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 17% rise in company filings mentions of blockchain in Q1 2023 compared with the previous quarter, with the highest share accounted for by Bayer, according to GlobalData’s analysis of over 60 pharmaceutical company filings. GlobalData’s Blockchain Market Size, Share, Trends, and Segment Forecast to 2030 report offers insights on application of blockchain in healthcare and other key sectors.

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System Restore in Windows

RX Note

Introduction System Restore is a powerful Windows feature that allows you to restore your computer to a previous point in time. This can be useful if you have installed a new program or driver that has caused problems with your computer, or if you have accidentally deleted or corrupted files. How System Restore Works System Restore works by creating restore points at regular intervals.

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Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

Pharma Leaders

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.

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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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FDA accepts Iovance’s BLA for melanoma therapy lifileucel

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Iovance Biotherapeutics’ biologics license application (BLA) for lifileucel to treat advanced melanoma. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy developed to treat advanced melanoma patients who advanced on or after prior anti-PD-1/L1 therapy and targeted therapy. It has been granted priority review by the FDA, with a target action date of 25 November this year, under the Prescription Drug User Fee Act (PDUFA).

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Unlocking Optimal Solid Pharmaceuticals: Integrating Fluidized Bed Drying into Wet Granulation

PharmaTech

In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids.

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Novavax receives positive opinion from CHMP for full MA of Covid vaccine

Pharmaceutical Technology

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). A protein-based vaccine, Nuvaxovid has been recommended for MA for use as a primary series in individuals of the age 12 years and above and as a booster in those aged 18 years and older to prevent Covid-19.

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More Flexibility for Production of Solids - Agile Systems for the Granulation Process

PharmaTech

Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids.

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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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Who’s saying what? Virtual Care mentions in company filings of pharmaceutical industry decreased by 38% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 38% drop in company filings mentions of virtual care in Q1 2023 compared with the previous quarter, with the highest share accounted for by ICON with 25% year-on-year decrease, according to GlobalData’s analysis of over 88 pharmaceutical company filings. GlobalData’s Telehealth Market Size by Segments, Share, Trends, and Forecast, 2022-2030 report provides key insights into business strategies, trends driving the telehealth market and granul

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Wet Granulation With Integrated Fluidized Bed Drying Solid Pharmaceuticals With Optimal Properties - How Can This Be Achieved?

PharmaTech

In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids.

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AstraZeneca’s Ultomiris (ravulizumab) Receives the MHLW’s Approval for the Prevention of Relapses in Patients with NMOSD

PharmaShots

Shots: The MHLW has approved Ultomiris (C5 complement inhibitor) for the prevention of relapses in patients with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD) incl. neuromyelitis optica The approval was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan. The trial met its 1EPs of time to first on-trial relapse as confirmed by an independent adjudication committee, zero relapses were seen with a median tre

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Who’s saying what? Regenerative Medicine mentions in company filings of pharmaceutical industry decreased by 24% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 24% drop in company filings mentions of regenerative medicine in Q1 2023 compared with the previous quarter, with the highest share accounted for by Sarepta Therapeutics with 20% year-on-year decrease, according to GlobalData’s analysis of over 578 pharmaceutical company filings. GlobalData’s Regenerative Medicine in Medical thematic intelligence report provides an overview of the current landscape, including healthcare, technology, regulato

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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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BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

PharmaShots

Shots: The EMA’s CHMP adopted the positive opinion recommending the approval of Opdivo + Pt-based CT for resectable NSCLC who are at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1% The opinion was based on the P-III trial (CheckMate -816) evaluating Opdivo (360mg, q3w) + CT vs CT alone which showed an improvement in EFS & pCR with 3 cycles of Opdivo + CT vs CT alone The safety profile was consistent with prior reported studies while the 3yr. data sho

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Who’s saying what? Microbiome mentions in company filings of pharmaceutical industry decreased by 30% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 30% drop in company filings mentions of microbiome in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novozymes with 9% year-on-year decrease, according to GlobalData’s analysis of over 50 pharmaceutical company filings. GlobalData’s Microbiome-Targeting Therapeutics in Infectious Diseases – Thematic Research report provides information on market classification by therapy and technologies, regulatory and m

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HanAll Biopharma and Daewoong Entered into Co-Development Agreement with NurrOn to Develop Novel Therapies for Parkinson's Disease

PharmaShots

Shots: The companies collaborated to discover & develop novel therapies for patients with neurodegenerative diseases incl. Parkinson's disease The collaboration will combine companies’ expertise and resources in developing NurrOn's ATH-399A & other compounds targeting Nurr1 for neurodegenerative disorders. The P-I trial of ATH-399A is expected to be initiated in 2023 The companies also continue to advance the therapy in other neurodegenerative diseases.

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Who’s saying what? Future of Work mentions in company filings of pharmaceutical industry decreased by 27% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced a 27% drop in company filings mentions of future of work in Q1 2023 compared with the previous quarter, with the highest share accounted for by Moderna with 13% year-on-year decrease, according to GlobalData’s analysis of over 419 pharmaceutical company filings. GlobalData’s Future of Work – Thematic Research report explains how the theme future of work is impacting the workforce across different sectors, it presents key technology, macroecono

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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.