Fierce Pharma

JUNE 26, 2023

The FDA's review teams were moving against an approval of Sarepta's Duchenne muscular dystrophy gene therapy. | The FDA's review teams were moving against an approval of Sarepta's Duchenne muscular dystrophy gene therapy. But Peter Marks, director of the agency's Center for Biologics Evaluation and Research, disagreed with the staffers' interpretations, coming to a "different conclusion" that led to an eventual approval, a memo shows.

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MedCity News

JUNE 26, 2023

Public health is heavily dependent on collecting and sharing accurate patient data. Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organizations to take ownership of their data quality by following best practices and adopting technologies that can detect and eliminate bad patient data before it is disseminated.

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Fierce Pharma

JUNE 26, 2023

Lundbeck CEO Deborah Dunsire is stepping down on a high note in the neuroscience company’s history. | Lundbeck CEO Deborah Dunsire is retiring on a high note in the neuroscience company’s history. After hitting the company's highest quarterly revenue in the first quarter, the five-year Lundbeck chief executive will pass the baton to UCB's neurology head.

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Sales 214

MedCity News

JUNE 26, 2023

New York Governor Kathy Hochul signed new legislation that will protect the state’s doctors, medical providers and facilitators who prescribe abortion care telehealth services to patients outside of New York from litigation in states where abortion services are banned or restricted.

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Fierce Pharma

JUNE 26, 2023

The potential advantages of a daily-pill version of popular GLP-1 drugs for Type 2 diabetes and obesity are obvious compared to the weekly-injection routine most patients taking these drugs undergo | The potential advantages of a daily-pill version of popular GLP-1 drugs for Type 2 diabetes and obesity are obvious compared to the weekly-injection routine most patients taking these drugs undergo.

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MedCity News

JUNE 26, 2023

Lawsuits filed in opposition to the White House’s drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government’s ability to negotiate price goes into effect.

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MedCity News

JUNE 26, 2023

Eyenuk recently received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system, which automatically detects diabetic retinopathy. The company said this FDA clearance makes its system the only AI system that is FDA-cleared for use with multiple retinal cameras produced by different manufacturers.

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Fierce Pharma

JUNE 26, 2023

On the heels of Eli Lilly’s landmark approval last summer, Pfizer is stepping up to the plate in alopecia areata—and it’s coming equipped with an adolescent nod to put the pressure on Olumiant. | Late last week, the FDA gave a green light to Pfizer’s once daily oral JAK inhibitor ritlecitinib—now christened Litfulo—in adults and children ages 12 and over with severe alopecia areata.

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Pharmaceutical Technology

JUNE 26, 2023

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

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Fierce Pharma

JUNE 26, 2023

Despite the controversy surrounding a relationship with departing director Alex Denner, Susan Langer has secured enough investor support to join Biogen’s board. | Despite the controversy surrounding a relationship with departing director Alex Denner, Susan Langer has secured enough investor support to join Biogen’s board.

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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.

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MedCity News

JUNE 26, 2023

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

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Competition FDA Biopharma Pharma 102

Fierce Pharma

JUNE 26, 2023

There was a decline in CEO compensation overall in 2022. But there was no evidence of the slide in biopharma where pay increases were plentiful.

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Biopharma 169

MedCity News

JUNE 26, 2023

A Northeast Business Group on Health survey, published Monday, found that 26% of employers never identify the needs of employees, nor the “awareness and effectiveness” of their mental health programs. About three in ten respondents don’t have messaging campaigns through social media and internal platforms on mental health.

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Media 101

PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. 1 The issue of access to medicines is addressed as part of the United Nations Sustainable Development Goals, with the objective to “provide access to medicines for all.

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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

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MedCity News

JUNE 26, 2023

FibroGen drug pamrevlumab has failed a Phase 3 study testing it in the chronic lung disorder idiopathic pulmonary fibrosis. It’s the second trial failure for the drug in the past month and the company’s third Phase 3 failure in the past two months.

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Biopharma Pharma 94

PM360

JUNE 26, 2023

The healthcare industry is coming to terms with the longstanding practice of clinical trials that underrepresented clinically relevant communities—a practice with potentially serious implications. In explaining the issue, the National Institutes of Health (NIH) notes that for years most trials were based on white male participants. Meanwhile the life sciences market research trade association, Intellus, noted that market insights participants are often white, female, and upper middle income, eve

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European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics. Dr Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research stated the regulatory body “hopes to outline the c

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Food and Drug Administration FDA Safety Food 85

PM360

JUNE 26, 2023

The world is abuzz about how generative artificial intelligence (AI), such as OpenAI’s ChatGPT, might revolutionize how we work. In one year, over 140 generative-AI startups launched, securing massive amounts of funding. Microsoft made a reported $10 billion investment in OpenAI, and other big tech firms, including Google and Meta, have launched their own generative AI tools.

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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

Medgadget

JUNE 26, 2023

BBy , a medtech company based in New York, has developed a spray drying method that hospitals can use to process human breast milk into a shelf-stable powder. Human breast milk is an incredibly important source of nutrition for neonates in intensive care units (NICUs). At present, human donor milk is frozen and must be defrosted prior to use in such facilities.

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Safety Healthcare Healthcare Medical 84

PM360

JUNE 26, 2023

Nothing is more humbling for a marketer than walking through the convention floor of ASCO 2023. You are surrounded by some of the world’s most brilliant minds fighting cancer, one of humanity’s greatest scourges. It is incredibly inspiring to see so many advances being made on so many fronts in this war. You see treatments and diagnostics evolving from one size fits all to being ever more personalized and precise.

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Marketing Patients Medical Medicine 97

MedReps

JUNE 26, 2023

There are plenty of new, innovative marketing methods out there. From social media to blogging and email newsletter lists, you have numerous options. However, sometimes the older, tried-and-true methods work best. If you’re looking to capture new customers in a more personalized manner, nothing works quite as well as these old-school marketing strategies.

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Medical sales Sales Sales pitches Marketing 80

PM360

JUNE 26, 2023

Over 300 drugs in the U.S. are in limited supply or unavailable, marking the worst national drug shortage in years. Patients struggle to get the necessary treatments, in some cases resulting in increased hospitalization and death. Although the driving factors of the shortage are complex, the bottom line is that drug manufacturers, particularly those that produce generic drugs, can’t afford to stockpile raw materials and products to prepare for shortages due to financial, storage capability, and

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Manufacturing Pharmaceutical manufacturing Pharma Management 97

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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

JUNE 26, 2023

Tuned’s new teen-focused solution, which launches Tuesday, caters to those aged 13 to 17 and will be offered as an employer-sponsored benefit. The program sends parents headphones and an iPad, which comes with two different hearing assessments.

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PM360

JUNE 26, 2023

Ensuring your company or product is presented first from a relevant search means that you are visible where competitors are hidden. It’s imperative that pharma businesses understand what their potential customers are searching for when they are typing into search fields. But pharma has had a tendency to shy away from search engine optimization (SEO) strategy; however, for those who do engage with SEO marketing, the rewards can be high.

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European Pharmaceutical Review

JUNE 26, 2023

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. The review summarised what the organisation has learned from conducting real-world data (RWD) regulator-led studies from September 2021 to February 2023. There were 61 RWD research opportunities identified, 30 studies initiated and 27 completed in this period.

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PM360

JUNE 26, 2023

Omnichannel marketing is a huge buzzword in pharma these days. As a late adopter channel, this uptick in interest is approximately a decade behind early adopter industries such as travel, CPG, and fashion. But how does the life sciences industry take this from a goal to a reality? First, let’s talk about omnichannel versus multichannel marketing. Multichannel marketing is running media in multiple channels, e.g., TV, connected TV (CTV), audio (terrestrial and streaming), paid search, paid social

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Media Marketing Pharma Sales 95

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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

Leads

Medgadget

JUNE 26, 2023

Scientists at Rice University have developed a highly flexible nanoelectrode that is designed for long-term implantation in the brain. The brain stimulation provided by the technology is incredibly fine-grained, thanks to the very low current it can deliver. This results in a very discrete area of neurostimulation, potentially allowing for much finer control of small groups of neurons.

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PharmaTimes

JUNE 26, 2023

The authorisation would include certain patients with refractory generalised myasthenia gravis - News - PharmaTimes

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Marketing Patients 83

Medgadget

JUNE 26, 2023

Researchers at the Singapore University of Technology and Design have created a flexible knee wearable that contains integrated circuitry within its knitted structure. The wearable can track joint movement in real time, assisting clinicians in spotting the early signs of movement disorders or allowing them to track the progress of patients undergoing physical therapy to improve their movement.

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PharmExec

JUNE 26, 2023

Drug expected to support children aged 4 and 5 with Duchenne muscular dystrophy.

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FDA 98

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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.

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