Mon.Nov 07, 2022

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GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval

Fierce Pharma

GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval. aliu. Mon, 11/07/2022 - 09:45.

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What Healthcare Insights Can We Gain from Space Exploration? [Sponsored]

MedCity News

In an interview, the deputy director and chief innovation officer of Translational Research Institute for Space Health, headquartered at Baylor College of Medicine, described some of the group’s work, adapting known tech for space applications and using space-based insights to improve healthcare at home.

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After beating third-quarter expectations, BioNTech strengthens sales outlook for the year

Fierce Pharma

After beating third-quarter expectations, BioNTech strengthens sales outlook for the year. kdunleavy. Mon, 11/07/2022 - 10:31.

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SirsiDynix CloudSource+ Now Offering Get It Now From CCC

Copyright Clearance Center

November 7, 2022, LEHI, Utah — CloudSource+ , the newest content solution for open access materials from SirsiDynix , has integrated with Get It Now from CCC (Copyright Clearance Center) to provide immediate purchase and delivery of full-text articles to unsubscribed journals. Get It Now is used by hundreds of academic libraries around the world to help expand their virtual collections.

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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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Viatris jumps into ophthalmology arena with pair of buyouts worth up to $750M

Fierce Pharma

Viatris jumps into ophthalmology arena with pair of buyouts worth up to $750M. zbecker. Mon, 11/07/2022 - 11:35.

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Consumers Need Better Communication From Their Health Plans, Survey Shows

MedCity News

More than half, or 58%, of health plan members are “overwhelmed” when it comes to managing their health plans. Insurers need to provide information in a way that’s accessible and easy to understand, the report stated.

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More Trending

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Debunking Cloud Cost and ROI Hogwash for Healthcare

MedCity News

The hogwash started in The Wall Street Journal with a contrarian take on a recent KPMG technology report. But cloud operates in a fundamentally different paradigm from the IT infrastructure of the past, and embracing big change is rarely free or easy. But the rewards of evolving are obvious and far too great to ignore.

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Amgen's Supreme Court bid answered in long-running Repatha patent feud against Sanofi, Regeneron

Fierce Pharma

Amgen's Supreme Court bid answered in long-running Repatha patent feud against Sanofi, Regeneron. fkansteiner. Mon, 11/07/2022 - 08:20.

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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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Viatris Sees Vision Drugs as Key to Growth and Commits $750M to Two M&A Deals

MedCity News

Two years after the close of the merger that formed Viatris, the company is acquiring Oyster Point Pharma and Famy Life Sciences to expand its scope in ophthalmology, one of three therapeutic areas it is now focusing on for revenue growth.

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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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First patients given lab-grown blood cell transfusion

European Pharmaceutical Review

Lab-grown blood cells have been transfused into a second patient in the world’s first-of-a-kind clinical trial , opening up future treatments for blood disorders such as sickle cell if found safe and effective. Stem cells from blood donors were separated and grown to produce modified red blood cells at NHS Blood and Transplant ( NHSBT ) Advanced Therapies Unit in Bristol.

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FDA Pauses Verve’s Trial Plan for Gene-Editing Therapy for High Cholesterol

MedCity News

The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol. No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K. and New Zealand where the clinical trial is already underway.

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The ins and outs of the life sciences: top hires for October 2022 

pharmaphorum

In this new segment from pharmaphorum, we collect the most significant hirings, firings, and recruitment stories from across the industry. This month, we highlight new appointments from Lumeris, Lineage Cell Therapeutics, 1910 Genetics, and ADC Therapeutics. . Ben Grabski, Lumeris. Lumeris, a value-based care managed services operator for health systems, has appointed Ben Grabski as chief financial officer.

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Why Payers and Employers Are Still Doubtful That Virtual Care Will Have a Revolutionary Impact

MedCity News

Insurers and employers are optimistic about the possibilities of virtual care, but they’re not very enthusiastic about the care modality’s larger influence on the healthcare industry, according to a recent report. Just 29% of employers and 34% of payers and benefits consultants said that virtual care will drastically change the way healthcare is provided and outcomes are achieved.

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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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Battery-Free Light-Powered Pacemaker Now a Reality

Medgadget

Researchers at the University of Arizona have developed a battery-free light-powered pacemaker that uses optogenetic stimulation of cardiomyocytes to achieve heart pacing. With conventional pacemakers, the leads of the device are anchored into the wall of the heart, using invasive hooks or screws. Small electrical shocks are then sent through the entire heart, potentially causing discomfort and pain.

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Supreme Court will decide if it was legal for a family to sue a nursing home for alleged improper care

MedCity News

Though the case started small, it has gained national attention and more than a dozen states have submitted an amicus brief in support of the Health and Hospital Corporation that operates 78 nursing facilities across Indiana.

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flipMD by GoodRx decreases physician burnout through medical matchmaking

PharmaVoice

Using flipMD, organizations can find, vet, connect with and source practicing board-certified physicians from all specialties for contract, project-based or full-time assignments.

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‘One Front Door’: Headspace Health Launches New Platform Following Merger with Ginger

MedCity News

The product — available January 1 — combines Headspace’s meditation and mindfulness services with Ginger’s coaching, therapy and psychiatry services. It also gives employers insights on their employees’ engagement and outcomes.

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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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Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSit

Legacy MEDSearch

Allotrope Medical Inc., a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation. This designation, along with a proposed additional indication for use, reflects StimSite’s value that while performing cystoscopy during open or minimally

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Highmark, Allegheny Health Network Adopt Cedar’s New Tech to Alleviate Billing Confusion

MedCity News

Cedar recently launched a new set of features to bring the disconnected ecosystem of healthcare entities together and make billing easier to understand for patients. Pittsburgh-based payer Highmark Health and its health system, Allegheny Health Network, are the first customers to implement the product, which Cedar dubbed its “payer intelligence layer.

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Breakthrough Therapy Designation for Pfizer bispecific antibody

European Pharmaceutical Review

Pfizer Inc. has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The designation is based on six months of follow-up data from a Phase II study ( NCT04649359 ) evaluating the safety and efficacy of a 76mg weekly (QW) dose of elranatamab, which showed overall response rate (ORR) was 61 percent. .

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Electrospun Construct Mimics Elasticity of Blood Vessels

Medgadget

Researchers at the University of Sydney in Australia have developed an electrospun blood vessel replacement. The material contains tropoelastin, a natural precursor for elastin, a key component of blood vessel walls. Elastin is present in concentric circles in natural blood vessels and provides the elastic properties which allow them to distend slightly and then reform their original shape in response to changes in blood flow and blood pressure.

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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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The pharmaceutical industry found it easier to fill artificial intelligence vacancies in Q3 2022

Pharmaceutical Technology

Artificial intelligence related jobs that were closed during Q3 2022 had been online for an average of 36.5 days when they were taken offline. This was a decrease compared to the equivalent figure a year earlier, indicating that the required skillset for these roles has become easier to find in the past year. Artificial intelligence is one of the topics that GlobalData, our parent company and from whom the data for this article is taken, have identified as being a key disruptive technology force

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How to be an Effective Medical Sales Leader

MedReps

Every medical sales team needs a good leader. These leaders are not only in charge of the team, helping their employees meet their sales goals and putting together effective sales pitches, but they also work as a liaison between upper management and the sales representatives. Clearly, there are many qualities that make someone an effective medical sales leader.

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Empagliflozin reduces risk of chronic kidney disease progression

European Pharmaceutical Review

Results from the EMPA-KIDNEY Phase III clinical trial announced at the American Society of Nephrology (ASN)’s Kidney Week 2022, demonstrated Jardiance ® (empagliflozin) reduced the risk of kidney disease progression or cardiovascular death by 28 percent versus placebo in adults with chronic kidney disease (CKD). The trial is the largest sodium-glucose co-transporter-2 ( SGLT2 ) inhibitor study ever conducted for CKD.

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AstraZeneca’s Farxiga data shows widespread undiagnosed chronic kidney disease

PharmaTimes

INSIDE-CKD study involves patients from across France, Germany, Italy, the US and Japan

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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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Alternative immunotherapies improve relapsed myeloma survival

European Pharmaceutical Review

Researchers from Mount Sinai and Memorial Sloan Kettering Cancer Center (MSK) have found that bispecific antibodies (BsAbs) , stem cell transplants and other CAR-T (chimeric antigen receptor T-cell) therapies offered relapsed multiple myeloma (RRMM) patients 18 months median overall survival (OS) after failed B-cell Maturation Antigen (BCMA) CAR-T therapy.

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After numerous setbacks, here’s where the Huntington’s pipeline stands

PharmaVoice

A look at emerging treatments and where there’s hope for patients.

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NICE backs digital CBT apps for youngsters with anxiety

pharmaphorum

Draft guidance in the UK has provisionally recommended that digital cognitive behavioural therapy (CBT) apps can be used within the NHS to treat children and young people with mild to moderate anxiety. The proposal by health technology assessment (HTA) agency NICE covers five apps, which can be used – with the support of a mental health practitioner – while further evidence is generated to see if the benefits they claim are realised in practice.

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Rivus presents results from trial evaluating controlled metabolic accelerator

PharmaTimes

HU6 data demonstrates significant selective weight loss across all body compartments

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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.