Mon.Sep 26, 2022

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How to stay at the forefront of healthcare innovation [Sponsored]

MedCity News

By applying a gig economy model to healthcare innovation, flipMD from GoodRx is lowering the barrier for physicians and businesses to connect and collaborate through an easy-to-use online platform.

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Microfluidic Device Mimics Embryonic Heartbeat to Stimulate Stem Cell Development

Medgadget

Scientists at the University of New South Wales in Australia have developed a method to produce human blood stem cell precursors from human pluripotent stem cells. The method may have use in treating cancer patients who require high doses of such blood stem cells to help replenish endogenous populations that have been destroyed by chemotherapy. The researchers exploited the tendency of cells to respond to mechanical stimuli and cultured the pluripotent stem cells in a microfluidic device that mi

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Influencer Marketing and Social Health: Optimizing Pharma’s Impact

pharmaphorum

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

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3 keys to value for unlocking the promise of cell therapies

PharmaVoice

There is no question about the incredible clinical impact cell therapies can have on the lives of patients. However, this impact is the result of innovation that does not equate to a simple, straightforward commercialization process.

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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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Pfizer, Sangamo resume haemophilia gene therapy trial

pharmaphorum

Pfizer and Sangamo have restarted recruitment of patients into their registration trial for haemophilia A gene therapy giroctocogene fitelparvovec, after the FDA lifted a clinical hold on the study. The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the clotting factor that giroctocogene fitelparvovec is designed to produce

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GM herpes virus fights advanced cancers

European Pharmaceutical Review

At the 2022 European Society for Medical Oncology Congress (ESMO) conference, promising results from a Phase I trial, suggesting that a novel genetically modified (GM) herpes virus eradicated or reduced advanced cancers, were presented. The GM herpes simplex virus (RP2) successfully treated twenty five percent of patients with different advanced cancers, including skin, oesophageal and head and neck cancers.

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AbbVie Cork facility €60 million expansion

European Pharmaceutical Review

AbbVie , an international R&D biopharmaceutical enterprise has celebrated its 20th anniversary by investing in extensive renovations at its manufacturing site in Cork, Ireland. The €60 million expansion will open 70 new jobs in sterile manufacturing, quality control and engineering in 2025. Construction at the Carrigtwohill facility built in 2013 is set to begin in 2023. “This latest investment is a fantastic opportunity for the Cork site and a recognition of the expertise and commitme

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Career Fair Tips for Medical Sales Rep Candidates

MedReps

Career fairs are great ways to apply for many jobs at once, or at least, speak with people from various medical companies who are looking for sales reps. In order to successfully navigate these career fairs, you need to be prepared for them. After all, you aren’t the only person in attendance who is looking for a job! You’ll run across some of your competition, making it crucial that you follow these career fair tips if you want to be part of the elite group that gets hired.

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Tilt collaborates with MSD on immunotherapy clinical trial

PharmaTimes

The study will focus on checkpoint inhibitor refractory non-small cell lung cancer

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Pfizer 20vPnC vaccine as safe as Prevenar 13®

European Pharmaceutical Review

Positive top-line Phase III study results from Pfizer’s major 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) indicate that it could help prevent invasive pneumococcal disease (IPD) and pneumonia. The trial, conducted with 4,700 infants and 800 toddlers and children of all ages ( NCT04546425 ), measured the vaccine’s immunogenicity and safety parameters against Prevenar 13 ® , a common paediatric vaccine.

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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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Peli BioThermal Introduces Tokyo Service Center

Pharmaceutical Commerce

New facility will focus on company’s temperature-controlled pallet shipper rental program.

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Ultomiris for generalised myasthenia gravis

European Pharmaceutical Review

The European Commission (EC) has granted adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG), a treatment-first with the drug Ultomiris (ravulizumab). With Ultomiris patients only require a treatment dose every eight weeks. gMG is a rare autoimmune disorder which causes reduced muscle function and atrophy.

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Navigo and Mannin agree to develop a novel drug for treating COVID-19

PharmaTimes

Precision X affinity ligand will enable the efficient purification of the non-Fc fusion protein

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EC approves Alexion’s Ultomiris for generalised myasthenia gravis

Pharmaceutical Technology

The European Commission (EC) has granted approval for AstraZeneca division Alexion’s Ultomiris (ravulizumab) as an add-on to standard therapy to treat generalised myasthenia gravis (gMG) in adults. The treatment is indicated for gMG patients who are anti-acetylcholine receptor (AChR) antibody-positive. In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion recommending a grant of marketing authorisation for Ultomiris.

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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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After a Decade of Regulatory Transformation, What’s Next?

Pharmaceutical Commerce

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape.

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Nordic Launches Ultra-Low Power Dual-Band Wi-Fi 6 Companion Chip

Pharmaceutical Technology

Concept: Norway’s semiconductor company Nordic Semiconductor (Nordic) has launched an ultra-low power dual-band Wi-Fi 6 companion chip called nRF7002. The company intends to compete in the competitive Wi-Fi IoT market for sensors and other low-power devices with its Wi-Fi-capable chip. Nature of Disruption: When used in conjunction with Nordic's current products, the nRF7002 offers Wi-Fi 6 connectivity and Wi-Fi-based location using service set identifier (SSID) detection of local hubs.

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The Use Of Qr Codes For Patient & Physician Support

Celeritas

QR codes emerged in the 90s with a few basic use cases and very few users. Over time they have come to represent a significant number of transactions, however. The QR code payment market is projected to rise to $35 billion by 2030. The market was already growing before covid, but the outbreak provided a significant boost to the technology. QR codes were initially reserved for marketing and sales-related functions, but recently they have made quite some headway in the medical field.

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UK NICE grants approval for breast cancer drug combination

Pharmaceutical Technology

The UK National Institute for Health and Care Excellence (NICE) has granted approval for Pfizer ’s palbociclib (Ibrance) in combination with anti-cancer therapy, fulvestrant, to treat advanced breast cancer patients. With the publication of the final draft guidance by the institute, the combination therapy will be offered for routine use in the National Health Service (NHS).

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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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Astellas facing generics to big-selling Lexiscan product in US

pharmaphorum

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. A US district court in Delaware has granted an interim injunction that will prevent Hospira from launching its generic version of Lexiscan (regadenoson injection) until 5 October, but said no to the Japanese drugmaker’s request for a preliminary injunction, which would prevent a la

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Monkeypox in Populations Presenting with Neurologic Syndromes Require Diagnosis

Pharmacy Times

Included in the literature review were the known neurologic complications of smallpox, including encephalitis, transverse myelitis, and acute disseminated encephalomyelitis.

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Better Therapeutics files for FDA approval of diabetes DTx

pharmaphorum

Digital health company Better Therapeutics has submitted its lead prescription digital therapeutic (DTx) BT-001 to the FDA, seeking approval for use by adults with type 2 diabetes (T2D). The filing has been made via the de novo clearance pathway – used for products which have no similar DTx devices on the market with which the company can claim substantial equivalence – giving BT-001 a shot at being first to market.

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That’s not Angry Birds — that’s your doctor learning about novel drugs through gaming

PharmaVoice

How pharma companies can teach physicians about mechanism of action and other medication lessons with interactive mobile games.

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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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4th Gene Therapy Analytical Development Summit 2022

pharmaphorum

The past twelve months have culminated in an unprecedented level of excitement, investment, and clinical progress within the gene therapy field. As the field strives to strike a delicate balance between safety and efficacy, in the context of increased regulatory scrutiny and safety challenges, attending the 4 th Annual Gene Therapy Analytical Development as an analytical scientist has never been so important.

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Beware the “New Google” (And Much More)

Copyright Clearance Center

The post Beware the “New Google” (And Much More) appeared first on Copyright Clearance Center.

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8th annual World Cancer Series Europe

pharmaphorum

The Economist ’s 8th Annual World Cancer Series: Europe convenes a wide range of stakeholders critical to effective cancer care, to drive innovation, equity and excellence in cancer control across Europe. The focus of this year’s conference is ”innovation, equity and excellence.” Our aim is to identify strategies to accelerate innovation, reduce inequities across cancer control in Europe, and to build towards universally excellent cancer control and cancer outcomes across the continent.

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Culturally Competent Care is a Large Part of Pharmacy Care, Deepening Community Connections

Pharmacy Times

Students from the Daniel K. Inouye College of Pharmacy at the University of Hawaii discuss the importance of culturally competent care in Hawaii.

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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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GSK names Burberry’s Julie Brown as its new CFO

pharmaphorum

GSK has said that its chief financial officer Iain Mackay will stand down from the role in May next year, to be replaced by Julie Brown, currently chief operating and financial officer at luxury fashion group Burberry. Julie Brown. Brown isn’t a newbie to the pharma sector, however, having previously held roles at UK drugmaker AstraZeneca and medical device player Smith & Nephew, as well as serving as a non-executive director and audit chair at Roche, before stepping down from that rol

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Study Suggests Moral Values Predict Regional Differences in COVID-19 Vaccination Rates

Pharmacy Times

The data showed moral concerns about fairness, loyalty, and purity influenced county-level vaccination rates, but care and authority did not.

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Sandoz spin-off continues Novartis’ focus on innovation; $22bn purchase rumoured

Pharmaceutical Technology

Novartis (Basel, Switzerland) has announced plans for a spin-off of its underperforming subsidiary, Sandoz, and will focus on innovative treatment approaches for haematology, solid tumours, immunology, neuroscience and cardiovascular-related diseases. The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis.

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The Value of Pursuing BCOP Certification Right After PGY2 Residency Completion

Pharmacy Times

Expert explains how delaying BCOP certification too long after a PGY2 residency can cause a “if you don’t use it, you’ll lose it” problem.

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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.