Mon.May 29, 2023

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In Therapeutic Innovation, Digital Must Be Held to the Same Rigor as Biotech

MedCity News

While these are key benefits of digital therapeutics and this optimism may have been laudable, this approach to market relies on promise without proof of efficacy and ignores the fact that not all digital therapeutics are created equal.

Marketing 132
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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.

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A Father’s Vision for New Kind of Gene Therapy Leads to a $100M Financing

MedCity News

Ray Therapeutics’ gene therapy is independent of the causative genes driving inherited vision disorders, which CEO Paul Bresge says is important for reaching a broad patient population. Rare disease retinitis pigmentosa is the first disease target, but the startup also plans to test its approach in more prevalent eye disorders.

Leads 107
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Commercial Payers’ Rising Claims Denials Rates Are Exacerbating Hospitals’ Financial Woes

MedCity News

Compared to government payers, commercial payers take significantly longer to pay hospitals and deny claims at a higher frequency — often without a justifiable reason to do so — according to a new report. Commerical payers have better reimbursement rates than government payers, but providers often have to wait 90 days or more get claims paid by commercial plans.

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A REVIEW OF MAGNETIC NANOPARTICLES IN TARGETED DRUG DELIVERY

Pharmatutor

A REVIEW OF MAGNETIC NANOPARTICLES IN TARGETED DRUG DELIVERY admin Mon, 05/29/2023 - 15:04 About Authors CHETNA MODI 1 *, VINIT MODI 2 , SHWETA RAY 2 , PIYUSH NARIYA 2 , VARSHA GADHVI 2 1 Professor, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. 2 Research Scholar, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. * chetnamodi306@gmail.

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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. One of these key technologies is automation, a recent paper explained. The authors offered clarification on the regulation and technologies to enable the cultural shift in the pharmaceutical environment, particularly within aseptic manufacturing and the use of robotics to fulfil good manufacturing practice (GMP).

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Retailers Are Making a Big Push Into Healthcare. Is Our Sector Ready?

MedCity News

While retailers already have a customer service focus, there is a steep learning curve to healthcare and the nuances of how things operate. It will be critical that these brands do their due diligence and invest in innovations that work to improve the fundamentals of healthcare such as efficient provider credentialing and flexible and sustainable working practices for providers.

Retail 89
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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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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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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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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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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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FivepHusion collaborates with Treehill, Syneos for Deflexifol

Pharmaceutical Technology

FivepHusion has collaborated with Treehill Partners and Syneos Health to strategically progress development and commercialisation of its chemotherapeutic formulation Deflexifol in markets across the globe. Under the partnership, Treehill will support FivepHusion with operational, strategic and transactional expertise along with integrated business development.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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.

Safety 52
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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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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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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Stability of Dry Powder Inhaler Protein Formulations

PharmaTech

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

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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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Interactive Case Studies: May 2023

Pharmacy Times

Cases address gastrointestinal issues and alcohol abuse.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Who’s saying what? Orphan Designated Drugs mentions in company filings of pharmaceutical industry decreased by 18% in Q1 2023

Pharmaceutical Technology

The global pharmaceutical industry experienced an 18% drop in company filings mentions of orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for by Horizon Therapeutics with 50% year-on-year increase, according to GlobalData’s analysis of over 182 pharmaceutical company filings. GlobalData’s New Drug Approvals and Their Contract Manufacture report provides critical insight into the contract manufacturing organization (CMO) industry by an

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Lowering Cholesterol Case Studies

Pharmacy Times

Cases discuss triglyceride levels, supplement use, and more.

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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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Decoding Price Transparency Data at HIMSS23

Clarify Health

When it comes to healthcare price transparency data, stepping into the world of healthcare cost and pricing often feels like navigating a labyrinth. So, the audience at the recent HIMSS 2023 in Chicago was grateful when Clarify Health’s Chief Analytics and Privacy Officer Niall Brennan, who is also head of the Clarify Health Institute (CHI), the research arm of Clarify Health , unpacked the complexities of this crucial topic during his presentation, “ The Price is Right (or is it?

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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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