Teva's new CEO Francis lays out his 'pivot to growth' strategy
Fierce Pharma
MAY 18, 2023
Teva's new CEO Francis lays out his 'pivot to growth' strategy kdunleavy Thu, 05/18/2023 - 11:24
Thu.May 18, 2023
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Building trust through transparency: Our pledge to provide more clarity around Web of Science journal coverage
Clarivate
MAY 18, 2023
As part of our on-going commitment to research integrity, we recently shared that we planned to investigate how we can provide greater transparency regarding which journals are covered in the Web of Science Core Collection. We thank our many community partners for their feedback and acknowledge the request for even more clarity around which journals are added or removed.
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AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease
Fierce Pharma
MAY 18, 2023
AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease kdunleavy Thu, 05/18/2023 - 15:54
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
MedCity News
MAY 18, 2023
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen
Fierce Pharma
MAY 18, 2023
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen fkansteiner Thu, 05/18/2023 - 15:17
Retail Clinics Are Gaining Momentum As They Vie for Their Piece of the Primary Care Pie
MedCity News
MAY 18, 2023
Retail clinic claims volumes have shot up by 200% in the past five years, according to a new report. The research argued that retailers are beginning to seriously compete with the traditional healthcare system when it comes to the primary care market — growth in retail clinic claims have greatly outpaced claims growth for urgent care centers, emergency departments and physician practices.
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Shifting to a More Holistic Approach Through 1115 Waivers
MedCity News
MAY 18, 2023
1115 waivers offer states a way to test new approaches in Medicaid that differ from what is required by federal statute. As we look at states leveraging Section 1115 Eligibility Changes, take notice of a strong emphasis on the justice-involved, housing/homelessness, and behavioral health.
After IRA, Minnesota's drug affordability proposal draws PhRMA's ire
Fierce Pharma
MAY 18, 2023
After IRA, Minnesota's drug affordability proposal draws PhRMA's ire zbecker Thu, 05/18/2023 - 11:38
EyePoint Pharma Sells U.S. Rights to Eye Med to Become Pure Play Drug Developer
MedCity News
MAY 18, 2023
By selling U.S. rights to Yutiq, EyePoint Pharmaceuticals gets $75 million cash to support its drug pipeline. The company’s lead product candidate is in mid-stage development for wet age-related macular degeneration and non-proliferative diabetic retinopathy.
After string of setbacks, FibroGen and AstraZeneca's anemia drug Evrenzo finally chalks up a win
Fierce Pharma
MAY 18, 2023
After string of setbacks, FibroGen and AstraZeneca's anemia drug Evrenzo finally chalks up a win aliu Thu, 05/18/2023 - 10:06
How Machine Learning Drives Clinical Trial Efficiency
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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.
Despite Economic Pressures, 90% of Employers Will Continue Wellbeing Programs, Survey Shows
MedCity News
MAY 18, 2023
Most employers are looking to maintain their investments in wellbeing programs, according to a survey from Fidelity Investments and the Business Group on Health. However, some areas of wellbeing will be emphasized more than others.
Bavarian Nordic's Jynneos vaccine up to 86% effective against mpox: CDC
Fierce Pharma
MAY 18, 2023
Bavarian Nordic's Jynneos vaccine up to 86% effective against mpox: CDC aliu Thu, 05/18/2023 - 12:50
Adonis Rakes In $17.3M to Optimize Providers’ Revenue Cycles
MedCity News
MAY 18, 2023
Adonis, a startup offering a revenue cycle automation platform purpose-built for healthcare, recently closed a Series A funding round led by General Catalyst. The company has raised nearly $23 million to date since launching last year.
'The Top Line': 2023's biopharma layoffs, plus this week's headlines
Fierce Pharma
MAY 18, 2023
'The Top Line': 2023's biopharma layoffs, plus this week's headlines tcarey Thu, 05/18/2023 - 16:13
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
EMA issues guidance amidst European medicine shortage
Pharmaceutical Technology
MAY 18, 2023
The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.
J&J beats back Viatris' generic challenge to schizophrenia med Invega Trinza
Fierce Pharma
MAY 18, 2023
J&J beats back Viatris' generic challenge to schizophrenia med Invega Trinza fkansteiner Thu, 05/18/2023 - 10:04
Advancing our commitments to global sustainability [Report]
Clarivate
MAY 18, 2023
Marko Damjanovic, Head of Corporate Sustainability at Clarivate, reviews our 2022 ESG milestones and highlights our 2023 goals for advancing our strategic commitments to the United Nations SDGs – all by accelerating our actions and by helping our customers achieve their goals. At Clarivate we put sustainability at the heart of our business goals and we want environment, social and governance issues to be the core of our global culture, serving as guiding principles for every decision we make.
Biden’s new pick to lead the NIH faces an uphill battle
PharmaVoice
MAY 18, 2023
Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
EMA guidance aims to prevent medicine shortages
European Pharmaceutical Review
MAY 18, 2023
A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA. Shortages can lead to medicine rationing, delay in critical treatments and can mean patients may need to use less-effective alternatives and face an increased risk of me
Which Health Tech Startups Are Competing at MedCity INVEST?
MedCity News
MAY 18, 2023
Healthcare startups focused on solutions for payers and hospitals as well as consumers and employers will compete in the Pitch Perfect contest at MedCity INVEST May 22-24 in Chicago. Register today!
First treatment conditionally licensed for chronic hepatitis D
European Pharmaceutical Review
MAY 18, 2023
Hepcludex ® (bulevirtide) is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain” The National Institute for Health and Care Excellence (NICE) has recommended NHS use of Hepcludex ® (bulevirtide). It is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain.
Direct-To-Consumer Startup for Functional Medicine Launches
MedCity News
MAY 18, 2023
Malla, a startup that launched Wednesday, is trying to make functional, personalized medicine more accessible. Consumers can purchase a membership, which includes one-on-one video sessions with a practitioner, messaging, personalized care plans and tracking.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
NICE recommends Rinvoq® for Crohn’s
European Pharmaceutical Review
MAY 18, 2023
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AbbVie’s upadacitinib (Rinvoq ® ) as an option for treating moderately to severely active Crohn’s disease in adults. The therapy is the first janus kinase (JAK) inhibitor that will be available for treatment of Crohn’s disease in England and Wales, AbbVie said.
5 Tips to Establish Collaborative Relationships Between Info Pros & Data Scientists
Copyright Clearance Center
MAY 18, 2023
The post 5 Tips to Establish Collaborative Relationships Between Info Pros & Data Scientists appeared first on Copyright Clearance Center.
MedCity INVEST Speaker Q&A: Thompson Coburn’s Daniel Tardiff [Sponsored]
MedCity News
MAY 18, 2023
The healthcare lawyer and former GC weighs in on pitfalls for healthcare startups and how executives can find success.
Debiopharm commences pivotal glioblastoma therapy study
PharmaTimes
MAY 18, 2023
The therapy is a brain-penetrant used in various combinations in patients with progressive glioblastoma
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
Negotiations Between UK and Switzerland are Underway
PharmaTech
MAY 18, 2023
The UK and Switzerland are negotiating a modern free trade agreement.
NICE recommendation for AbbVie’s Rinvoq
PharmaTimes
MAY 18, 2023
The approved drug has been developed to treat patients with moderate to severe Crohn’s disease
Elevar submits new drug application for uHCC combo therapy
Pharmaceutical Technology
MAY 18, 2023
HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer. The application is supported by positive results from the Phase III CARES 310 randomised, open-label, international trial.
New Partnership Launched by Connect in Pharma for Global Health Innovation
PharmaTech
MAY 18, 2023
The new partnership hopes to increase funding and awareness of global health security challenges and highlight the role of the pharmaceutical industry in increasing access to medicines and improving health worldwide.
Accelerating Clinical Supply Through Integrated Drug Development
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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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