Fri.Nov 11, 2022

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Viatris executive charged in insider trading scheme that allegedly netted $7.2 million

Fierce Pharma

Viatris executive charged in insider trading scheme that allegedly netted $7.2 million. kdunleavy. Fri, 11/11/2022 - 11:30.

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Device Measures Hemoglobin More Accurately in Dark Skin

Medgadget

Researchers at the University of Texas at Arlington, in collaboration with Shani Biotechnologies, a local firm, have created a point-of-care device that can accurately measure hemoglobin levels and perform pulse oximetry in individuals with dark skin. At present, methods to determine hemoglobin levels at the point of care, such as pulse oximetry, are inaccurate in individuals with higher levels of melanin in their skin, and there is a clear need to develop alternatives that work for everyone.

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AstraZeneca poised to lock horns with Merck, BMS and more as Imjudo-Imfinzi combo snags lung cancer approval

Fierce Pharma

AstraZeneca poised to lock horns with Merck, BMS and more as Imjudo-Imfinzi combo snags lung cancer approval. fkansteiner. Fri, 11/11/2022 - 09:02.

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The legacy of Glen de Vries: Our last interview with the pioneering entrepreneur

PharmaVoice

Recorded just weeks before his passing, our sit-down interview with the legendary medical sciences entrepreneur showcased his passion for pushing the industry toward its next frontier.

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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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Biogen's incoming CEO Viehbacher gets mixed reviews—and lots of advice—in investor survey

Fierce Pharma

Biogen's incoming CEO Viehbacher gets mixed reviews—and lots of advice—in investor survey. kdunleavy. Fri, 11/11/2022 - 09:37.

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EC grants approval for Sanofi-GSK’s Covid-19 booster

Pharmaceutical Technology

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.

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How AI-enabled Remote Patient Monitoring Reduces Staff Burden, Enables Care at Home

MedCity News

Via AI-enabled RPM, healthcare organizations can reduce stress and burnout for nurses and clinical staff, an especially important consideration in a time of widespread healthcare staff shortages that are expected to continue.

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Leveraging technology to meet HCPs and patients on their own terms

Fierce Pharma

Leveraging technology to meet HCPs and patients on their own terms. mteefey. Fri, 11/11/2022 - 14:45.

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AstraZeneca reports 9% rise in Q3 2022 total revenue

Pharmaceutical Technology

AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.

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How PulsePoint is helping pharma marketers reach patients

Fierce Pharma

How PulsePoint is helping pharma marketers reach patients. mteefey. Fri, 11/11/2022 - 15:25.

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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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A Changing Economy: Why Managed Services Can Help You Do More, Faster

MedCity News

Whether it’s application services for your EMR, service desk support, staffing, or any other host of needs, a managed services partner can take your organization to the next level while providing one thing money can’t buy—peace of mind.

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Twitter trolls, Musk’s changes tank stocks for Lilly, other insulin makers

pharmaphorum

Elon Musk’s Twitter takeover has been nothing of tumultuous, and that tumult hit home for pharma Thursday when an account impersonating Eli Lilly and Company, taking advantage of lax oversight in the new Twitter Blue program, tweeted “We are excited to announce insulin is free now” Insulin is, of course, not free, especially in the United States where a vial of Humalog, Lilly’s insulin product, can cost upwards of $300 and competing products from Sanofi and Novo Nordisk a

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Greater Good Health Launches Leadership Program to Shine Spotlight on NPs’ Role in Primary Care

MedCity News

When we talk about how building the primary care workforce, we usually focus on physicians. But Greater Good Health is taking a different approach by leveraging nurse practitioners. The company recently launched a leadership program for nurse practitioners to learn clinical and communication skills from one another.

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First oral treatment approved for post-transplant refractory cytomegalovirus

European Pharmaceutical Review

Takeda has announced the European Commission’s (EC) authorisation for livtencity TM (maribavir), the first oral UL97 protein kinase inhibitor in adults with post-transplant refractory cytomegalovirus (CMV), who are also resistant to one or more therapies. The drug has been approved for adults who have had haematopoietic stem cell transplants (HSCTs) or solid organ transplants (SOTs) and are resistant to standard antivirals including ganciclovir, valganciclovir, cidofovir and foscarnet.

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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.

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Spotlight on women in pharma: ?eyda Atadan Memi?, Takeda

pharmaphorum

As part of our Women in Pharma series, where we talk to leading figures in the life sciences, we hear from ?eyda Atadan Memi?, recently appointed general manager for Takeda UK and Ireland. Here, she discusses her new role, key steps to a successful career in life sciences, and her plans for the future. What inspired you to pursue a career in the life sciences?

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QA of prostaglandin analogues for glaucoma treatment

European Pharmaceutical Review

A paper, published in the European Journal of Pharmaceutical Sciences identified the quality assurance (QA) challenges and trends of analytical techniques in ocular drug delivery and formulation, focusing on treatments for glaucoma. The paper suggested low bioavailability after topical ophthalmic administration is evidence of the need for more effective molecules, as well as formulations that target sites more precisely.

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Stanford prof pays investors in defunct biotech Nuredis $29m

pharmaphorum

A prominent genetics professor at Stanford University in the US has paid $29 million to investors in Nuredis – a biotech that has now been wound up – after a California court found he misrepresented the company to investors. Dr Stanley Cohen was sued by Alafi Capital and the Christopher Alafi Family Trust – the only investors in Nuredis – in 2018. The lawsuit claimed he misled them whist persuading them to invest $20 million in the biotech, set up to develop a candidate therapy for neurodegenera

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Autoimmune Biotech Zenas Gets $118M to Take Antibody Drug Into Phase 3

MedCity News

Zenas BioPharma’s Series B financing was the biggest one of the week. Other startups that emerged with new cash include Juvena Therapeutics, Sensorium Therapeutics, and NRG Therapeutics.

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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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Implanted Magnets for Prosthetic Control

Medgadget

Engineers at MIT have developed a system that could let users of robotic prostheses to more sensitively control their bionic limbs. The technology involves implanting pairs of small magnetic beads into muscles. When the muscles contract, the beads move closer together, allowing prosthetic devices to more precisely calculate a user’s intentions and mirror these.

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IQVIA’s report card for clinical trial diversity: must do better

pharmaphorum

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. So has the situation started to improve? Sadly not, says a new report from IQVIA, which looked specifically at the inclusion of Black/African Americans and Hispanics in clinical trials in recent years.

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Judge Pan Releases Antitrust Publishing Case Opinion

Copyright Clearance Center

The post Judge Pan Releases Antitrust Publishing Case Opinion appeared first on Copyright Clearance Center.

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Stada and Xbrane gain EU approval for biosimilar Ximluci

PharmaTimes

Partnership combines Xbrane’s protein-expression system with Stada’s management teams

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out new developments from Opala, Wheel, GoodRx, Fathom, Tivic Health, and more.

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Bristol Myers Squibb opens 125-acre biologics campus in Dublin

PharmaTimes

Facility also includes a cell culture suite, quality control laboratories and technology labs

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Measuring the intangible – what is the true value of a “patient centric” initiative

pharmaphorum

Panel. Mark Doyle, Founder of the Method and A Life in a Day. Susan Hendrich, Learning Director, Respiratory, Immunology & Infectious Disease, AstraZeneca. Emma Sutcliffe, Global Patient Officer, Ipsen. Jonah Comstock, Editor-in-Chief, pharmaphorum. The post Measuring the intangible – what is the true value of a “patient centric” initiative appeared first on.

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Patrick Ellis Who Dares Sells Book Review

Contrarian Sales Techniques

In Who Dares Sells, Patrick Ellis shares the most effective strategies and techniques that can help you achieve success in sales. He also reveals the secrets of his success. The goal of this book is to provide a comprehensive analysis of the psychology of sales success, including the various techniques and principles that are used to achieve this. It shows the reader how these are used to achieve success.

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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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Pharma’s growth in Africa needs domestic focus and investment

Pharmaceutical Technology

Investment in AI-based research and development, and a focus on the major diseases that affect people in Africa could facilitate the domestic pharmaceutical industry’s growth and reduce the dependence on imports, experts said at a recent event. Earlier this week, in a panel on “Pharma in Africa” at the Financial Times Global Pharma and Biotech Summit, various stakeholders delved into ways to advance the pharmaceutical industry on the continent.

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6 Ways to Prioritize the Patient Voice in Patient Journey Research

pharmaphorum

Within the pharma industry, patient journey mapping tends to begin with a focus on an identified commercial opportunity. Multiple data sources are then integrated to map the patient journey and pinpoint needs that align with the identified opportunity. However, when patient journeys rely heavily on HCP feedback or big data sources as the backbone, patient-reported experience gets undervalued—and potential opportunities are missed.

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The Evolution of the Cold Chain Logistics Industry

Pharmaceutical Commerce

Ways the sector has grown over the years, and how it will continue to adapt in the future.

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AHIMA22 Global Conference – Keynote from Roberto Ascione

pharmaphorum

Our CEO & Founder, Roberto Ascione , has been invited to close Day 2 of the virtual AHIMA22 Global Conference as a keynote speaker, November 11, 2022. Aligning with AHIMA22’s theme of “ The Future of Health Data “, Roberto’s keynote at the end of Day 2 of the conference will focus on themes from his book “ The Future of Health “, providing an insightful and inspirational overview of global digital health trends and the future of health care.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.