Fierce Pharma

JULY 12, 2023

As another SGLT2 diabetes drug hits the market, the obvious question is: How will it find a way to compete against formidable blockbusters Farxiga and Jardiance? | TheracosBio and Mark Cuban's online distributor Cost Plus Drug Company have partnered to provide newly approved SGLT2 inhibitor Brenzavvy at a major discount to competitors in the class, including AstraZeneca's Farxiga and Eli Lilly and Boehringer Ingelheim's Jardiance.

Marketing 231

Marketing 231

Clarivate

JULY 12, 2023

Clarivate provides researchers with a more holistic and comprehensive view of the scholarly landscape within a single platform with the integration of discovery of dissertation and thesis metadata records sourced from ProQuest Dissertations & Theses Global In an era where access to reliable and comprehensive research materials is crucial, Clarivate has taken a significant step towards enhancing the research experience.

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Networking Medicine Government 98

Fierce Pharma

JULY 12, 2023

Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday in federal court in Washington, D.C. | Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday for a decision without a trial. In its request for a summary judgment, Merck reiterated its claim that the drug price negotiation program violates the First and Fifth Amendments of the Co

Government 217

Government 217

Pharma Marketing Network

JULY 12, 2023

The internet is a vast resource of information on health and wellness. However, not all of this information is created equal. Some of it is accurate and reliable, while other information may be misleading or even harmful. This is especially true when it comes to pharmaceutical-sponsored health information. Pharmaceutical companies have a vested interest in promoting their products, so it’s important to be critical of any information they put out.

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Pharmaceutical Doctors Government Consulting 98

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Distribution

Fierce Pharma

JULY 12, 2023

Five weeks after getting no response from the U.S. | Five weeks after getting no response from the U.S. Department of Health and Human Services on his request for more information on the potential financial impact of Eisai and Biogen’s newly approved Alzheimer’s treatment Leqembi, Sen. Bernie Sanders (I-Vt.) has sent a follow-up letter to the HHS. The drug has been priced at $26,500 per patient per year.

Patients 205

Patients 205

PharmExec

JULY 12, 2023

Recent data and commentary offer insights into how biologics vs. small molecule patent protections under the Inflation Reduction Act pricing scenarios is impacting investing in the biotech sector.

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Pharma Marketing Network

JULY 12, 2023

The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. Patient-centric pharmaceutical marketing is based on the understanding that patients are more than just consumers of drugs.

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Pharmaceutical Marketing Patients Healthcare Provider 98

Fierce Pharma

JULY 12, 2023

A new triumvirate of biopharma bigwigs is in line to reign over one of the industry’s top trade groups. | The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has unveiled the upcoming lineup for its CEO leadership team over the next two years. Captaining the group as IFPMA’s new president and chair of the organization’s CEO steering committee will be Pfizer chief Albert Bourla.

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Pharmaceutical manufacturing Biopharma Manufacturing Pharmaceutical 192

MedCity News

JULY 12, 2023

Sonio recently gained $14 million in Series A funding. The Paris-based startup’s AI platform automates ultrasound reporting so that healthcare providers can conduct ultrasound exams with greater accuracy, speed and efficiency.

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Healthcare Provider Healthcare Healthcare 93

Fierce Pharma

JULY 12, 2023

Two years after it enriched itself with 16 Sanofi drugs, Germany’s Stada Arzneimittel is purchasing another clutch of consumer health brands across multiple European countries. | Stada is dropping an undisclosed sum on a range of Sanofi consumer health products with “well-established” footholds in places such as Belgium, Germany, Hungary, Spain and the United Kingdom, plus Nordic countries.

Medicine 189

Medicine 189

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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

JULY 12, 2023

Reducing errors and improving patient safety have been considered a top priority since the 1999 IOM report “To Err is Human: Building a Safer Health System” was released. While some great strides have been made, it’s been almost 25 years and we are still seeing year-over-year increases in reported errors.

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Safety Patients 93

Fierce Pharma

JULY 12, 2023

Lupin is no stranger to FDA rebukes, though its latest write-up from the U.S. drug regulator certainly could have been worse for the company. | Following an inspection of Lupin’s Pithampur Unit-2 manufacturing facility in Madhya Pradesh, India, from March 21 to March 29, the FDA handed the company an inspection with a classification of Voluntary Action Indicated.

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Manufacturing FDA 188

European Pharmaceutical Review

JULY 12, 2023

The first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa, has been prequalified by the World Health Organization (WHO). MenFive ® has been developed through a 13-year collaboration between the world’s largest vaccine manufacturer Serum Institute of India Pvt. Ltd. (SIIPL) and PATH, with funding from the UK government.

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Government Safety Manufacturing Pharmaceutical 95

Fierce Pharma

JULY 12, 2023

By Fernanda Teles, Head of Global Clinical Operations, DHL Supply Chain | How decentralized clinical trials can be delivered with ease, driving patient engagement and improved outcomes

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Patients 130

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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

JULY 12, 2023

CVS Caremark and GoodRx created a new program called Caremark Cost Saver, which will become available starting January 1, 2024. Through the program, eligible CVS Caremark commercially insured members will have access to GoodRx’s prescription pricing on generic medications.

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Prescription Insurance Medical 90

Fierce Pharma

JULY 12, 2023

Author: Mike Cioffi, Senior Vice President, Clinical Solutions and Strategic Development, WCG | Patients need to be involved in developing ePRO assessments from the outset, especially for endpoints without existing standards or scales. Ideally, sponsors and CROs would solicit patient insight early in endpoint development. Too often, however, study startup timelines take precedence over patient input.

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Patients 130

MedCity News

JULY 12, 2023

The OIG recently added some teeth to the anti-information blocking regulations laid out in the 21st Century Cures Act. The office finalized penalties, including fines of up to $1 million for health IT companies found blocking the electronic flow of health data. Interoperability expert Troy Bannister said that these fines are a good starting point for ensuring greater interoperability, but he isn’t too sure the OIG will be able to effectively enforce them.

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Electronics Healthcare Healthcare 90

Pharmaceutical Commerce

JULY 12, 2023

Medicare-eligible patients need to be enrolled in registry to get Medicare coverage for the anti-beta amyloid drug that is priced to cost $26,500 a year.

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FDA Patients 98

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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

MedCity News

JULY 12, 2023

Hospitals and health systems, overburdened by pandemic-induced staff shortages, are in need of tech to improve workflows, reduce stress and save money. The claims denial process, which is a significant time suck and prone to errors, is ripe for innovation.

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Pharmaceutical Commerce

JULY 12, 2023

AmerisourceBergen’s new 34,000 square-foot plant in Chicago area will support shipments that require temperature storage/delivery as cold as cryogenic.

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Pharma 98

MedCity News

JULY 12, 2023

Illumina must pay a €432 million fine for closing its Grail acquisition before the European Commission finished its inquiry into the tie-up. The penalty is the maximum amount the regulator can impose on a company for breaching European merger rules.

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Biopharma 88

PharmaVoice

JULY 12, 2023

A new psychedelic guidance from the agency gives a clue into how it could analyze drugs in the space, but industry leaders are eager for more.

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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

JULY 12, 2023

Nvidia’s investment isn’t just working capital for Recursion Pharmaceuticals’ technology-driven drug discovery research. Recursion says it will get more computing power as well as the possibility of joining forces with Nvidia in research.

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Pharmaceutical Biopharma 85

Pharmaceutical Technology

JULY 12, 2023

Innovate UK’s New Cancer Therapeutics programme awarded the grant to the Imperial College spinout to support pre-clinical development.

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MedCity News

JULY 12, 2023

Providers just aren’t given the time it takes to build rapport and ask the right questions within the fee-for-service model. That’s why I left traditional medicine. Providers like me who now work in an employer healthcare model can truly help people versus treating them reactively.

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Healthcare Healthcare Leads Patients 82

Pharmaceutical Technology

JULY 12, 2023

The EMA is reviewing data on the potential effects of high-profile GLP-1RAs in causing suicidal thoughts and thoughts of self-harm.

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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

MedCity News

JULY 12, 2023

The invention of 3D visualization software and virtual dissection tables have revolutionized how we teach and explore human anatomy.

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Education Medical 95

Pharmaceutical Technology

JULY 12, 2023

To that end, the company presented positive top-line Phase III results for its once-daily stimulant for ADHD.

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FDA 98

Medgadget

JULY 12, 2023

Moximed , a medtech company based in California, has developed the MISHA knee system, an implantable shock absorber for use in patients with knee osteoarthritis. The system is designed as an alternative to total knee replacement, and can help to reduce pain and discomfort for patients when performing daily activities, such as walking. The system is implanted on the outside of the knee, beneath the skin, and there is no need to remove bone, muscle, or ligament, resulting in a much faster patient

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Patients FDA 73

PharmaTimes

JULY 12, 2023

Company adds a number of additional brands from Sanofi following initial take overs in 2021 - News - PharmaTimes

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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