Sat.Aug 20, 2022 - Fri.Aug 26, 2022

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What should DTC do?

World of DTC Marketing

Consumers would ask their doctor about an advertised prescription drug in a perfect world. In our REAL world, that isn’t the way it happens. Is there a disconnect between what DTC marketers think will happen and what happens with DTC? The research was straightforward. Ask current patients what drove them to get an Rx for a branded product (MS drug).

Doctors 243
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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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Magnetic Microrobots Assist with Root Canal Treatment

Medgadget

Researchers at the University of Pennsylvania have developed a microrobot system that can help with biofilm disruption, drug delivery, and sample retrieval, all within the restrictive space of the root canal. It can be difficult for dentists to know if they have removed all the infectious material when performing a root canal, and failure to do so will typically result in an infection reoccurring.

Medical 133
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Amazon Care and Care Medical are shutting down. Is it really that big a deal?

MedCity News

This is the second time Amazon has failed to crack the employer market said an industry observer, after the company loudly touted the novelty of its approach. The first was the high-profile dissolution of Haven created as a joint venture between Amazon, JPMorgan Chase and Berkshire Hathaway. But does this latest failure even matter?

Medical 119
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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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Half of cancer deaths are preventable

World of DTC Marketing

Globally, nearly half of deaths due to cancer can be attributable to preventable risk factors, including three leading risks of smoking, drinking too much alcohol, or having a high body mass index, a new paper suggests. According to the Lancet “, although some cancer cases are not preventable, governments can work on a population level to support an environment that minimises exposure to known cancer risk factors.

Food 229
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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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In the current venture climate, tech for pharma is recession-proof

MedCity News

Specialty drugs reportedly reached 50 percent of all drug spending in 2020, a figure that has increased significantly over the last decade.

Pharma 132
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What is pharma’s responsibility for online health information?

World of DTC Marketing

Research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information on the Internet. Additionally, 49% have accessed a website that provides information about a specific medical condition or problem. Many people get health information from the Internet but are left on their own to determine if it’s credible.

Doctors 227
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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

Medicine 105
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EEG Caps for Brain Organoids

Medgadget

Researchers at Johns Hopkins University have created tiny EEG caps for brain organoids. The team was inspired by full size EEG caps that are used to measure brain activity in human patients. Previously, the Hopkins researchers were forced to use flat electrode arrays that were originally designed to take recordings from cell monolayers, but applying a flat surface to a round organoid only results in measurements from a handful of cells that make full contact.

Leads 109
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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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The business of empathy: How pharmacists can improve performance by improving the human connection

MedCity News

When pharmacies engage on a human level with patient support programs, patients become more fully engaged in their treatment, leading to potentially significant health benefits and good business for pharmacies.

Leads 114
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Bayer unit BrainVectis cleared to start Huntington gene therapy trial

pharmaphorum

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of

Safety 104
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How Non-Profits Can Affordably Create Impactful Video

Storyvine

It's a new day for non-profits and advocacy organizations. More than ever, your message needs to be heard. But with time and resources limited, what's the best way to do that? Video is the most popular form of content—78% of people watch online videos once a week—and it's especially effective for non-profits. With a real person telling a real story, combined with music and good editing, you can take your audience on an emotional journey that is very powerful.

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Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Protecting patient data as risk of cyberattacks grows

MedCity News

The healthcare industry is under constant threat from cyberattacks. By adopting the measures identified in this article, healthcare organizations can help to improve their cybersecurity and mitigate risk.

Patients 115
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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

Patients 113
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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is banking on a collaborative approach to scientific innovation to address the growing problem of drug resistance in tuberculosis (TB). Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023.

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CCC and Chinese Medical Association Publishing House Partner to Provide Global Licensing Solution for CMA Articles

Copyright Clearance Center

CCC has contracted with the Chinese Medical Association Publishing House (CMAPH) to offer document delivery and licensing solutions for all CMAPH journals. CMA titles are now included in the Republication License Service on CCC Marketplace and Document Delivery with RightFind. CMAPH is the leading publisher of medical journals in China, including the prestigious Chinese Medical Journal and National Medical Journal of China.

Medical 98
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Moderna’s Covid-19 vaccine patent suit points to different virus to make infringement case against Pfizer

MedCity News

Moderna is suing Pfizer and BioNTech, claiming they copied its messenger RNA work in developing their Covid-19 vaccine. The company notes that its patented work in respiratory infectious disease began years before the start of the Covid-19 pandemic, when the biotech was pursuing an mRNA vaccine for a different coronavirus.

Biopharma 111
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Fatty liver disease: With little early detection, more challenging drug development

pharmaphorum

For most of my adult life, I had been the typical American fat guy, gaining a pound or two a year and thinking little of it. That was until my doctors stunned me with the news that I had cirrhosis caused by non-alcoholic steatohepatitis, or NASH, a severe form of fatty liver disease that often has few or no symptoms until very late stages. I had never heard of NASH, and I was even more shocked when I started searching online and discovered the prevalence of the disease and the tragic reality tha

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First 90 Days: Agios Pharmaceuticals’ Brian Goff

PharmaVoice

The rare disease veteran and first-time CEO is bringing his expertise to the company as it launches the first FDA-approved treatment for pyruvate kinase (PK) deficiency.

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Oncolytic viruses: past and present

European Pharmaceutical Review

IN 2022, treating glioblastoma (GBM) remains an uphill battle. Current therapeutic options show limited success and neuro-oncology teams often struggle to balance their benefits with a patient’s quality of life. Cutting-edge strategies, however, are now revisiting the use of oncolytic viruses – viruses that selectively infect and kill cancer cells – which may broaden and advance the therapeutic landscape.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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CMS calls on states to tie Medicaid payments to quality measures for nursing homes

MedCity News

States that do this can improve staffing and outcomes for patients in nursing facilities. Some states, like California and Illinois, have already implemented initiatives that incentivize nursing homes through Medicaid payments.

Patients 108
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Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft

Marketing 109
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With market success at stake, can tech help solve the diversity problem in clinical trials?

PharmaVoice

Diversity in clinical trials isn’t only important for the health of the overall patient population — it can save millions in lost profits.

Marketing 105
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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018. 2.

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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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DotCom Therapy expands pediatric healthcare access by accepting Medicaid

MedCity News

Pediatric teletherapy provider DotCom Therapy has been approved to accept Medicaid through Wisconsin’s BadgerCare Plus program. It’s the first Medicaid contract for the company, which has primarily worked with schools and commercial insurers in the past.

Insurance 107
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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

FDA 98
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The story behind the PharmaVoice 100

PharmaVoice

Taren Grom, our editor-in-chief emeritus, explains how the coveted PharmaVoice 100 awards got its start and what makes it stand out in the industry.

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New study use musical tests for early detection of cognitive decline

PharmaTimes

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.