Fierce Pharma

JUNE 12, 2023

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

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Healthcare Healthcare 345

MedCity News

JUNE 12, 2023

he FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.

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Fierce Pharma

JUNE 12, 2023

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

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Sales goal Sales 327

Healthcare Success

JUNE 12, 2023

Consumers across the globe have come to rely on search engines for reliable, trustworthy, accurate, and timely healthcare information. This has significantly increased competition among providers, making SEO—particularly local SEO—a crucial part of any digital marketing strategy. Local SEO is beneficial for any size business but critical for multilocation companies.

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Fierce Pharma

JUNE 12, 2023

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement. | Following a deal with Amgen, J&J has granted Alvotech and Teva a license to launch their Stelara biosimilar no later than Feb. 21, 2025.

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Marketing 260

Pharmaceutical Technology

JUNE 12, 2023

Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceutical products, orphan drugs and other life-saving medicines.

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MedCity News

JUNE 12, 2023

Penn Medicine recently published a study on the economics of providing telemedicine — it showed that when the health system began offering virtual urgent care services to its employees, the visits ended up being 23% less expensive to conduct than in-person appointments.

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European Pharmaceutical Review

JUNE 12, 2023

Novo Nordisk intends to invest 15.9 billion Danish kroner (€2.1 billion) to expand an existing active pharmaceutical ingredient (API) production facility in Hillerød, Denmark. The investment, which begins in 2023, will create additional production capacity and increase Novo Nordisk’s ability to meet future market demands. “This important investment will ensure the continuous development of our late-phase pipeline into deliveries of important medicines for treatments to patients worldwide,” state

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MedCity News

JUNE 12, 2023

In an interview, Nathan Ray, a partner with the healthcare and life practice who oversees M&A/PE related work in that industry for West Monroe, highlighted how his firm works with companies to drive due diligence for clients, and help acquired companies address issues and differentiate during holds,

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Healthcare Healthcare Biopharma 91

PharmaVoice

JUNE 12, 2023

Tris Pharma’s CEO is “betting the company” on a pain reliever with the power of an opioid and a lower chance of addiction.

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Pharma 98

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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 12, 2023

Medical schools and residency training programs push trainees away from primary care and make primary care seem less prestigious. Medicare is the largest payer of graduate medical education, so Medicare could require additional outpatient primary care training in residency to encourage Family and Internal Medicine trainees to enter outpatient primary care, where the need is critical.

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Training Education Medicine Medical 91

MedReps

JUNE 12, 2023

Communication is the key to having good employee morale, a solid company culture and plenty of respect for those in charge. However, these things can only be achieved when the medical sales representatives hear particular information from the company’s leaders, rather than their sales managers. Some things need to be conveyed by those in charge so important questions can be answered.

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Sales Management Sales Management Medical sales 85

MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx. Fortunately, this propelled innovation, and transitioned DTx from up-and-coming to a high-demand field.

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Food and Drug Administration Prescription Government FDA 90

Medgadget

JUNE 12, 2023

The human body has a deep connection with electricity. The transmission of electrical impulses is responsible for the movement of our limbs, the functioning of our organs, and the formation and recall of memories. The signatures of the various electrical signals emanating from our body can be telltale signs of our health, and a jolt of electricity can literally bring us back from the brink of death.

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Electronics Education Engineering Medicine 79

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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

MedCity News

JUNE 12, 2023

Accolade added Equip to its Trusted Partner Ecosystem, a collection of health vendors vetted by Accolade that its customers can decide to contract with. Equip virtually connects patients struggling with an eating disorder with a five person care team, which includes a medical physician, dietician, therapist, peer mentor and family mentor.

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Physicians Medical Patients 83

PharmaTimes

JUNE 12, 2023

The treatment candidate, known as MDI-26478, is a positive allosteric modulator of the AMPA receptor - News - PharmaTimes

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MedCity News

JUNE 12, 2023

Patients yearn for care experiences that are more convenient, personal and accessible. However, clinicians aren’t doing a great job of delivering this kind of care, according to a new report. The staffing crisis has put clinicians under a lot of pressure — they feel they often don’t have time to deliver adequate care of get effectively trained on how to use new technology.

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Patients Training Healthcare Healthcare 82

Medgadget

JUNE 12, 2023

Engineers at the University of California San Diego have developed a low-cost cuffless blood pressure monitor. The device is a clip that attaches over a smartphone camera and flash. The user presses their finger against the clip, and the system can infer the amount of blood passing through the finger, and the amount of pressure being exerted on the clip by the finger.

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Engineering Medical Patients Medicine 68

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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

PharmaTimes

JUNE 12, 2023

Objective response rate and complete response rates were encouraging for both treatments - News - PharmaTimes

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Pharmaceutical Technology

JUNE 12, 2023

Clinical-stage biotechnology firm Eccogene has raised $25.23m (CNY180m) in a Series B financing round to support the development of its clinical-stage metabolic pipeline. Co-led by Zhangjiang Healthcare Venture Capital and New Alliance Capital, the financing round has seen participation from existing investors Qingsong Capital, Delos Capital and Oriza Seed Capital.

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Distribution Patients Healthcare Healthcare 59

PharmaTech

JUNE 12, 2023

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

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Pharmaceutical Technology

JUNE 12, 2023

Novartis will buy US-based clinical-stage biopharmaceutical company Chinook Therapeutics in a $3.5bn deal. Chinook common stockholders will receive $3.2bn and $0.3bn in cash through contingent value rights upon achieving certain regulatory milestones. The deal is a merger of a newly formed subsidiary of the company with Chinook, which has two late-stage medicines currently under development to treat IgA nephropathy (IgAN), a rare, progressive chronic kidney disease.

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Medicine Healthcare Healthcare Leads 59

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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

InCrowd

JUNE 12, 2023

This is the first Pride Month that I am ringing in as a registered nurse, and while I have been out and proud for 13 years or so, I’m experiencing a renewed connection to the importance of celebrating my community. As the corporate rainbows unfurled, we heard the familiar chorus of complaints and boycotts. From Bud Light to Target, an echo chamber of dissent emerged from those who oppose one of the core reasons why Pride is essential: Visibility.

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Healthcare Healthcare Safety Patients 52

Pharmaceutical Technology

JUNE 12, 2023

The global pharmaceutical industry experienced a 120% rise in company filings mentions of internet of things in Q1 2023 compared with the previous quarter, with the highest share accounted for by Moderna, according to GlobalData’s analysis of over 61 pharmaceutical company filings. The growing application of Internet of Things will prove to have a transformative impact across the Healthcare sector.

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Pharmaceutical Government Competition Marketing 52

Pharma Leaders

JUNE 12, 2023

Private equity and growth capital firm EdgeCap Partners has acquired a majority stake in Bulgarian clinical research solutions organisation (CRO) Comac Medical. Comac founder and CEO Dr Milen Vrabevski and its other shareholders will retain a significant minority stake. The companies have not disclosed the financial terms of the deal. Established in 1997, Comac Medical offers a complete range of early to late-phase drug development services across different therapeutic areas to pharmaceutical an

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Medical Pharmaceutical 52

Pharmaceutical Technology

JUNE 12, 2023

The global pharmaceutical industry experienced a 149% rise in company filings mentions of cloud in Q1 2023 compared with the previous quarter, with the highest share accounted for by Pfizer with 14% year-on-year decrease, according to GlobalData’s analysis of over 140 pharmaceutical company filings. GlobalData’s Cloud Computing in Healthcare – Thematic Intelligence report offers a detailed understanding of how Cloud impacts the value chain in the Pharmaceutical sector.

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Pharmaceutical Healthcare Healthcare Leads 52

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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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Legacy MEDSearch

JUNE 12, 2023

Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANT TM system for FDA 510(k) clearance. The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive blood culture, which is designed to be used with traditional automated AST systems and Disk Diffusion, accelerating routine AST turnaround times by up to one day. “The global emergence of supe

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. All six members of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted in support of the Phase III Clarity AD (NCT03887455) data being adequate to verify the clinical benefit of Leqembi as an Alzheimer’s disease treatment, based

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Food and Drug Administration Side effects Prospecting FDA 52

PharmaVoice

JUNE 12, 2023

While online cookies revolutionized online advertising and are a big part of a $600 billion dollar industry, targeting consumer/patient behavior is about to get much more difficult

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Patients 52

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. The over-the-counter (OTC) marketing authorisation for the gel as a de novo medical device means the FDA has followed suit after the treatment received CE marking in Europe and UKCA marking in the UK in 2021 and 2022, respectively.

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Food and Drug Administration FDA Prescription Food 52

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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