Medical Device Success

SEPTEMBER 27, 2022

Reading time: 2 – 4 minutes. Fact is, women have more challenges in pursuing their careers than men. In the show notes you will find a link to the McKinsey 2021 report on Women in the Workplace that clearly spells this out. To address these challenges, Shelly O’Donovan, CEO, Authentic Influence Group is creating a Life Science Women’s Mastermind group in the MedTech Leaders community.

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MedCity News

SEPTEMBER 27, 2022

Prime Medicine likens its gene-editing technology to a word processor that searches for the correct place in the genome to make an edit, replacing or repairing a wide variety of target DNA. The preclinical biotech is now spelling out its future plans with the letters I-P-O.

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Clarivate

SEPTEMBER 27, 2022

Water is essential to survival and yet extreme, less predictable weather conditions are affecting its availability in many regions. In our blog series about Highly Cited Researchers and the UN Sustainable Development Goals (SDGs), we turn our attention to SDG 6: Clean Water and Sanitation. We analyze the emerging trends for this SDG and discuss how some of the top researchers are tackling the water crisis and its challenges related to climate change and wastewater treatment.

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MedCity News

SEPTEMBER 27, 2022

Chronic conditions cause medical debt in U.S. households across all income levels, according to a new report. Medical debt has frequently been associated with cancer and, more recently, diabetes treatment, but there are other chronic conditions that contribute significantly to medical bills — such as heart disease, asthma, anxiety and lung disease.

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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

Distribution

Legacy MEDSearch

SEPTEMBER 27, 2022

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation (NPS ) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

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MedCity News

SEPTEMBER 27, 2022

If single use devices are inevitable, the next step after “why” needs to be an understanding of “how” medtech companies and device makers can get on the right side of the movement.

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Medical 119

MedCity News

SEPTEMBER 27, 2022

Among CVS Health’s adult members, there was a 34.1% decrease in suicide attempts in 2022, compared to 2019. However, there was a 32% increase among adolescents, largely due to challenges from Covid-19. In response, CVS Health is expanding its resources with new initiatives that focus on adolescents.

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European Pharmaceutical Review

SEPTEMBER 27, 2022

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. The guidance , called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices.

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MedCity News

SEPTEMBER 27, 2022

Kaiser Family Foundation discovered Medicare Advantage plans and traditional Medicare had similar rates of satisfaction among enrollees. However, there were a select few differences between the plans, with MA enrollees more likely to get preventive care and traditional Medicare enrollees more likely to receive care from the highest-rated facilities.

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European Pharmaceutical Review

SEPTEMBER 27, 2022

Researchers have developed and optimised a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous detection of chlorpheniramine maleate (CPM) and ibuprofen (IBF) in a pharmaceutical formulation. CPM and IBF are one of the most prevalent over-the-counter cold and cough medications, available in various multi-component formulations.

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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.

Safety

MedCity News

SEPTEMBER 27, 2022

Seagen’s cancer drug research and collaborations have focused on the development of antibody drug conjugates. By licensing rights to a preclinical Lava Therapeutics asset, Seagen gets a shot to develop a different kind of antibody therapy that could compete against approved products from Johnson & Johnson and Takeda Pharmaceutical.

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pharmaphorum

SEPTEMBER 27, 2022

The emergence of PD-(L1) treatments has provided patients options where previously none existed, and the leading forms of these therapies have gone on to blockbuster sales. Ben Hargreaves finds that the next step to enhance these treatments further could be to find synergies with emerging therapies employing similar modes of action, such as therapeutic cancer vaccines.

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MedCity News

SEPTEMBER 27, 2022

Fewer people are dying from cancer due to advances in research, screening and treatment, according to a new report. In order for the death rate to fall further, U.S. oncologists must prioritize personalized treatment and addressing social determinants of health, an expert argued.

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Pharmaceutical Technology

SEPTEMBER 27, 2022

Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children. The companies sought authorisation for booster vaccine usage in children aged five to 11 years. Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/

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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.

Specialization

MedCity News

SEPTEMBER 27, 2022

Digital health technologies have received plenty of attention, cash and sky-high valuations but do they deserve it? In the latest episode of MedCity’s Pivot podcast, CEO of Hinge Health says companies need to validate their results in order to move the industry forward.

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Healthcare Success

SEPTEMBER 27, 2022

Philadelphia retailer John Wanamaker once said, “Half the money I spend on advertising is wasted; the trouble is I don't know which half.”. And truthfully, it’s probably more for many businesses. Years ago, it was common for healthcare providers to ask, “How did you hear about us?” when you called to schedule an appointment or ask a question. Though well-intentioned, this first step toward identifying the best marketing channel for your business relied solely—and heavily—on front office personne

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MedCity News

SEPTEMBER 27, 2022

Cultural, racial and socioeconomic barriers play a role in barriers to access, from cultural hesitancy around seeking care to distrust of healthcare institutions to the stigmatizing of Medicaid beneficiaries. As a result, engaging these populations is highly complex, highly nuanced work.

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Healthcare Healthcare 108

Scott’s Directories

SEPTEMBER 27, 2022

The impact of the COVID-19 pandemic in 2020 has completely changed healthcare marketing. This has led to the evolution of how healthcare businesses interact with patients and perform their operations. Some healthcare businesses have devised ways to adapt to these changes. They implement advanced strategies such as optimizing the Ontario physician directory for their marketing strategies.

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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.

Safety

PharmaTech

SEPTEMBER 27, 2022

Tue, Sep 27, 2022 11:00 AM EDT In this webinar, failure modes that can occur on a perfectly sealed container will be discussed along with how to determine if a CCIT failure is a true container leak or something else.

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Penrod

SEPTEMBER 27, 2022

What could possibly happen at work that we’d end up with a video like this? Penrodpalooza, that’s what. One (very magical) time per year, Penrod holds a Penrodpalooza; this is a time when all employees are brought together from all over the States (we’re currently dispersed across 24 states!) to our headquarters in Milwaukee, Wisconsin for a few days.

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Pharmacy Times

SEPTEMBER 27, 2022

Patients could have a better immune response against the omicron variant of COVID-19 with a second booster of the bivalent mRNA-1273.214 vaccine at a 50 ?g dose.

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pharmaphorum

SEPTEMBER 27, 2022

Biogen has finalised a $900 million payment to settle a whistleblower lawsuit claiming that it paid kickbacks to US doctors to prescribe its multiple sclerosis drugs. According to a Department of Justice statement , the payment resolves the suit filed on behalf of the federal government by former Biogen employee Michael Bawduniak, under the whistleblower (qui tam) provisions of the False Claims Act.

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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.

Management

Pharmacy Times

SEPTEMBER 27, 2022

Omidenepag isopropyl ophthalmic solution (Omlonti) eye drops are indicated to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.

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Safety FDA Sales Leads 101

Pharmacy Times

SEPTEMBER 27, 2022

The value of a patient-first approach and telehealth for addressing the complex health coordination needs of those with these pulmonary conditions has never been more critical.

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Patients 32

pharmaphorum

SEPTEMBER 27, 2022

A submission to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) of a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 through 11 years old has been made by BioNTech and Pfizer, it emerged yesterday. With a corresponding application for extension of marketing authorisation at the European Medicines Agency (EMA) to be made in days, the EUA request is supported by safety, immunogenicity, and preclinical data from

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Food and Drug Administration FDA Safety Food 59

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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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