Thu.Apr 27, 2023

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Quitting Lilly's obesity drug tirzepatide may be difficult for many patients, exec says

Fierce Pharma

Quitting Lilly's obesity drug tirzepatide may be difficult for many patients, exec says kdunleavy Thu, 04/27/2023 - 15:08

Patients 260
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In Which Areas of Healthcare Do Investors Want More Startup Activity?

MedCity News

While the digital health sector might feel a little cramped in some areas, there are wide open spaces in others — and investors are ready to funnel money into companies looking to innovate these lesser-discussed aspects of care delivery and healthcare technology. Some of these areas include Medicaid, generative AI and patient-to-patient support.

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Trending Sources

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Pascal Soriot deflects shareholder discord over AstraZeneca's legal battles amid 'very encouraging' start to the year

Fierce Pharma

Pascal Soriot deflects shareholder discord over AstraZeneca's legal battles amid 'very encouraging' start to the year fkansteiner Thu, 04/27/2023 - 09:39

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Changing the Course of Women’s Health Takes Persistence – Here’s What We’ve Learned

MedCity News

Taking inspiration from one of the most influential women in modern medicine, Elizabeth Blackwell, who was the first American woman to earn a medical degree, we must persist – with optimism, courage and a fearless commitment to create a more equitable future for all women.

Medicine 114
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol's multiple new launches won't stop it from scouting for M&A deals, CEO says

Fierce Pharma

Bristol's multiple new launches won't stop it from scouting for M&A deals, CEO says aliu Thu, 04/27/2023 - 10:16

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Report: 21% of Adults Without a Vehicle or Public Transportation Skip Care

MedCity News

About 8% of Black adults and 7% of Hispanic adults skipped care because of transportation challenges in the last year, compared to 4% of White adults and 2% of Asian adults, according to the Robert Wood Johnson Foundation. In addition, 14% of adults with low family incomes passed on care.

More Trending

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Exploring the impact of globalization on research in the United States

Clarivate

Our latest Global Research Report from the Institute for Scientific Information (ISI) , “U.S. research trends: The impact of globalization and collaboration,” raises important questions about how well past investment has prepared the U.S. scientific enterprise to achieve its goals. Our findings suggest that while the U.S. remains a leading science and technology power, it must acknowledge its shrinking domestic research capacity and work collaboratively with resourceful competitors to maintain i

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After recent M&A moves, Merck CEO says he's thinking beyond Keytruda's eventual downfall

Fierce Pharma

After recent M&A moves, Merck CEO says he's thinking beyond Keytruda's eventual downfall kdunleavy Thu, 04/27/2023 - 12:50

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EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

Pharma 105
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As Humira biosims take hold, longtime AbbVie CEO Richard Gonzalez talks succession plans

Fierce Pharma

As Humira biosims take hold, longtime AbbVie CEO Richard Gonzalez talks succession plans zbecker Thu, 04/27/2023 - 12:30

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How Machine Learning Drives Clinical Trial Efficiency

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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Quest Expands in Cancer Testing With $300M Haystack Oncology Acquisition

MedCity News

Quest Diagnostics is acquiring liquid biopsy company Haystack Oncology. The startup’s technology is used for identifying cancer patients who need adjuvant therapy.

Patients 109
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Fierce Pharma Asia—Daiichi's leukemia delay, Enhertu gains; Glenmark's settlement

Fierce Pharma

Fierce Pharma Asia—Daiichi's leukemia delay, Enhertu gains; Glenmark's settlement aliu Thu, 04/27/2023 - 22:47

Pharma 130
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Startup Aims To Bring Culturally Competent Care to Neurodivergent Adults Through Partnership

MedCity News

Through a new partnership, Hopper Health’s providers and peer navigators will receive a personalized training plan from Violet that will help the clinicians and navigators understand how to provide inclusive care for patients of color and LGBTQ+ communities. It will teach topics including anti-racism, allyship, social determinants of health, trauma-informed care and other areas.

Training 102
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'The Top Line': A special series on Narcan, the life-saving nasal spray

Fierce Pharma

'The Top Line': A special series on Narcan, the life-saving nasal spray tcarey Thu, 04/27/2023 - 15:30

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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In Rare Move, CMS Fines 2 Hospitals for Price Transparency Violations

MedCity News

CMS recently fined two hospitals for alleged violations of its price transparency rule. These fines are only the third and fourth penalties issued by the agency since the rule took effect on January 1, 2021. These fines may become more common — CMS also announced that it is updating its enforcement process for the rule.

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Immunotherapy to become standard treatment for infants with ALL

European Pharmaceutical Review

Immunotherapy treatment blinatumomab will now become standard treatment worldwide for babies with acute lymphoblastic leukaemia (ALL). This decision is based on new results from an international trial published in the New England Journal of Medicine. Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy.

Safety 98
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Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

MedCity News

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy.

FDA 100
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Seres and Nestlé Health receive FDA approval for Vowst microbiome therapy

Pharmaceutical Technology

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Realising the potential of AAV gene therapies

European Pharmaceutical Review

Through pre-clinical and clinical trial success, adeno-associated viral vectors (AAVs) have consistently demonstrated their effectiveness as a tool for gene delivery to treat a variety of human diseases. As we stand at the precipice of an era that truly embraces gene therapies, there are clearly still a number of challenges to overcome to fully realise the potential of innovative AAVs.

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Organ on a Chip Technology: Discussion with Yaakov Nahmias (INTERPHEX 2023)

PharmaTech

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.

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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up. Solving this issue will improve industry best practice, increase public confidence and create a more efficient pathway to patients; but it necessitates enhanced collaboration between companies.

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PCC 2023: ESG, New Turf for Compliance

PharmExec

While ESG is still in the early stages for pharma, many companies are moving forward with a need for compliance.

Pharma 98
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Biologic could be first new hidradenitis suppurativa treatment in a decade

European Pharmaceutical Review

[the CHMP’s recommendation of Cosentyx] brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade” The Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for biologic Cosentyx ® (secukinumab). The recommendation for a marketing authorisation “brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade,” commented Marie-France Tschudin, President of Novartis I

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Workflow of the Future: Sustainable Business Models Webcast

Copyright Clearance Center

The post Workflow of the Future: Sustainable Business Models Webcast appeared first on Copyright Clearance Center.

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Bristol Myers Squibb appoints new CEO

European Pharmaceutical Review

Christopher Boerner, PhD, Executive Vice President (EVP), Chief Commercialization Officer of Bristol Myers Squibb will become the company’s new CEO on November 1 2023. Effective immediately, Boerner has been named its EVP, Chief Operating Officer. The pharma company’s current CEO and Chairman of the Board Dr Giovanni Caforio will retire on November 1 2023.

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LogiPharma Europe 2023: The Advantages of Sea Freight

Pharmaceutical Commerce

From logistics lessons learned, how pharma can navigate new opportunities surfacing in ocean shipping.

Pharma 95
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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King's College London and Grünenthal join forces to ease pain

PharmaTimes

Duo will collaborate to develop pluripotent stem cell-based microfluidic cultures for pain research

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NICE recommends Kite’s CAR-T therapies to treat blood cancer

Pharmaceutical Technology

The UK’s National Institute for Health and Care Excellence (NICE) has recommended two new personalised immunotherapy therapies from Kite Pharma to treat aggressive forms of blood cancer for the Cancer Drugs Fund (CDF). Established in 2011, the CDF is a source of funding to increase patient access to cancer drugs in the UK. The recommended chimeric antigen receptor (CAR) T-cell therapies include Yescarta (Axicabtagene ciloleucel) and Tecartus (Brexucabtagene autoleucel).

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Amphera and Alligator Bioscience reveal mitazalimab-MesoPher update

PharmaTimes

Therapy is being used during pivotal phase 1 study into patients with pancreatic cancer

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Designing a provider incentive program that influences practice patterns

Clarify Health

In this 4-minute video, Jayson Harpster , Product Director for Clarify’s provider incentive software and program, discusses how payers can influence practice patterns and drive provider behavior change inside busy medical practices. Watch to learn three critical components of designing an effective provider incentive program. Transcript: In health care, we often have tons of data with no clear way to use it to drive real change.

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Accelerating Clinical Supply Through Integrated Drug Development

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.