Tue.Jul 04, 2023

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.

Leads 130
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Women’s Health Startups Graduate from PharmStars Digital Health Accelerator

MedCity News

A new cohort of startups has graduated from PharmStars, a digital health accelerator. This latest group focused on women’s health and health equity.

Biopharma 116
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Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

Medical 111
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Reality Test of Medicine Shop without Registered Pharmacist

Pharmatutor

Reality Test of Medicine Shop without Registered Pharmacist admin Tue, 07/04/2023 - 15:39 ABOUT AUTHOR Dr. R. S. Thakur Renowned Professor of Pharmaceutical Fraternity & Former Member of Pharmacy Council of India. Email : drramsthakur@gmail.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ISO publishes standard on bacterial endotoxin testing

European Pharmaceutical Review

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). The document contains requirements and guidance for testing for bacterial endotoxins. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.

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Abeona Therapeutics raises funds to launch cell therapy

Pharmaceutical Technology

Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.

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Teva reveals critical Ajovy data

PharmaTimes

Therapy has been developed to reduce the frequency, duration and severity of migraine attacks - News - PharmaTimes

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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many.

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King’s College London and Pioneer Group in incubator link-up

PharmaTimes

Collaboration aims to revitalise two empty sites on the South Bank of London by providing several laboratories - News - PharmaTimes

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Formulation In-Depth Focus 2023

European Pharmaceutical Review

Trends in capsule formulation In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market. Titanium dioxide: are there alternatives? Mike Tobyn from Bristol Myers Squibb, Jonathan Kaye from GSK, David Harris from MSD and Eli Lilly’s Jason Melnick discuss the role of E171 (titanium dioxide) in the identification of solid oral dosage forms.

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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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5 Critical Keys to Avoid Derailment of Drug Development: Delaying the Application of a First-Rate Quality System is Risky Business

PharmaTech

Any responsible business or industry takes quality seriously. It’s crucial to customer safety and satisfaction, and its prioritization in the development of healthcare products and services – especially pharmaceuticals – is obviously even more so. Nonetheless, it can be easy in development for smaller teams and companies to overlook some components of Quality, despite governmental requirements around complex quality initiatives.

Safety 52
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Recommendations and considerations for bacteriophage therapy usage in clinical settings

European Pharmaceutical Review

The rise in antimicrobial resistance , 1 lack of significant antimicrobial discovery in recent years, and increasing instances of multidrug-resistant (MDR) microorganisms 2 have propelled the interest in bacteriophage (Phage) therapy as a potential new course of treatment. Patients with implantable devices are more prone to biofilm-mediated infections, 3 while other infections such as skin structure infections, chronic lung diseases resulting from respiratory infections, and urinary tract infect

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Nursing Today And The Best Medical Sales Rep’s Approach with Daniel Wright

Evolve Your Success

What is the best way for a medical sales rep to approach a medical professional in a hospital setting? What is the state of nursing today, and what challenges is the profession taking? What do nurses need to know if they want to consider medical sales as an alternative career? These are three very interesting questions that our guest for this episode tackles.

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Novel oral therapy shows potential in plaque psoriasis

European Pharmaceutical Review

JNJ-2113, the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide in development for moderate-to-severe plaque psoriasis (PsO) has demonstrated positive results in a Phase II trial. Janssen’s Phase IIb FRONTIER 1 clinical trial for adult participants achieved all primary and secondary efficacy endpoints, according to topline results showcased by Bissonnette R, Pinter A, Ferris L, et al. at the World Congress of Dermatology 2023.

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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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Amneal receives Xyrem generic approval after patent disputes

Pharmaceutical Technology

Amneal follows a successful year of approvals with six more approvals for generics across multiple indications.

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Using Analytical Advancements to Assess Biosimilarity

PharmaTech

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

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US FDA declines to approve Amneal’s Parkinson’s treatment

Pharmaceutical Technology

The US FDA has issued a complete response letter to Amneal Pharmaceuticals, declining to approve its IPX203 to treat Parkinson’s disease.

FDA 52
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Drug Product Impurities Testing

PharmaTech

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

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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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Moderna seeks EMA approval for modified Covid-19 vaccine

Pharmaceutical Technology

Moderna has filed a regulatory application seeking EMA approval for its modified Covid-19 vaccine targeting the XBB.1.5 sub-variant.

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Three ways to improve participant engagement in your digital clinical trials

Pharmaceutical Technology

How can you reduce drop-out, save time and resources, and maintain participant engagement throughout the entirety of your trial?

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NorthX acquires Valneva’s biologics production unit

Pharmaceutical Technology

NorthX Biologics has acquired Valneva’s clinical trial manufacturing unit in Stockholm, Sweden to bolster its expertise.

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Cancer Immunotherapy Month – 2022 saw a record number of approvals

Pharmaceutical Technology

Over the last ten years, the number of approved innovator immuno-oncology therapies (immunotherapies) has increased.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Venous thromboembolism market projected to grow at 2.6% CAGR between 2022 and 2032

Pharmaceutical Technology

The venous thromboembolism (VTE) market is expected to grow from $3.6bn to $4.6bn globally, according to GlobalData.

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Tonix acquires Upsher-Smith’s migraine products

Pharmaceutical Technology

Tonix Pharmaceuticals and Tonix Medicines have acquired two migraine products from Upsher-Smith Laboratories.

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Labcorp forms spin-off of Fortrea

Pharmaceutical Technology

The spin-off will create a new global Phase I-IV CRO, patient access and technology solutions.

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FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Pharmaceutical Technology

The gene therapy prevents neovascularisation from a single, intravitreally delivered injection.

FDA 97
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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