Mon.Oct 24, 2022

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Former Uber Health founder launches new startup with a fresh take on egg freezing

MedCity News

Cofertility is a new startup aiming to make egg freezing more accessible by tying it to egg donation. The startup offers women two programs: Keep and Split. With Keep, women can pay to freeze their eggs and store them all for their own later use. The Split program allows women to freeze their eggs for free when they give half to a family who can’t otherwise conceive.

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The Google SERPs have changed. Have you?

Clear Pivot

People often forget just how much the format of Google search engine result pages (SERPs) have changed over time. I noticed it in particular recently, when I was planning out a house move.

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3 key reasons why Americans are under-utilizing primary care

MedCity News

In order to engage more Americans in primary care, we need to understand the main challenges that surround primary care in the U.S., according to Dr. Stephen Ezeji-Okoye, Crossover Health’s chief medical officer. Some of these include the increasing shortage of primary care physicians and the lack of incentivization to focus on whole-person health and preventive care.

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Steep drop for UK industry clinical trials between 2017 and 2021

European Pharmaceutical Review

The number of industry clinical trials initiated in the UK, per year, fell by 41 percent from 2017 to 2021, according to the latest annual report on clinical research from the Association of the British Pharmaceutical Industry ( ABPI ). The report ‘Rescuing Patient Access to Industry Clinical Trials in the UK’ stated that patient care, the NHS, and economic growth are all declining because of this collapse.

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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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1st amendment doesn’t protect anti-abortion activists who recorded Planned Parenthood, 9th Circ says

MedCity News

In an opinion published Friday by Ninth Circuit Judge Ronald Gould said, “Invoking journalism and the First Amendment does not shield individuals from liability for violations of laws applicable to all members of society.”.

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Checking the box on digital engagement isn’t enough

PharmaVoice

In a recent study, 50% of healthcare consumers reported that a bad digital experience with their provider ruined the entire experience, while 39% felt that a good digital interaction had a positive influence.

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UK research consortium given £2 million to control monkeypox

European Pharmaceutical Review

A new UK research consortium will lead the way in overcoming the monkeypox pandemic with £2 million of funding from The Biotechnology and Biosciences Research Council (BBSRC) and the Medical Research Council (MRC), both part of UK Research and Innovation (UKRI). The financial aid will support the group to develop better diagnostic tests, determine potential therapies, as well as study vaccine effectiveness and the virus’ spread.

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Meeting the needs of rare disease patients: Improved access to specialty pharmaceuticals, gene and cell therapies

MedCity News

Specialty carve outs that move specialty drugs away from traditional prescription drug management to a pharmacy benefit administrator (PBA) or specialty administrator will continue and likely to provide cost savings.

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First UK-licensed melatonin for children with insomnia and ADHD

European Pharmaceutical Review

Adaflex, the UK’s first melatonin product for six to 17 year-olds diagnosed with ADHD and insomnia (where sleep hygiene measures have been inadequate), is now available in the UK. Melatonin is commonly used to treat insomnia. However until now, prescribing a treatment for children with ADHD has been off-label or unlicensed in the UK. AGB-Pharma , the Swedish pharmaceutical company that produced the drug, predicted around 60 percent of all melatonin prescriptions are dispensed to under 18s off-la

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Alpine stops enrollment in cancer drug study after second patient death this year

MedCity News

The patient who died in the Phase 1 test of Alpine Immune Sciences drug, davoceticept, reportedly suffered the same cardiovascular complication as the first patient. The biotech company is stopping enrollment in two clinical tests of the drug and assessing all patients in the studies.

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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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Biosimilars will gain ground in 2023 with Humira launches — and that’s just the beginning

PharmaVoice

In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

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How to navigate the biotech investment downturn: Get back to basics

MedCity News

There is no arguing that the last year has been a rocky one for biotech companies, but trends suggest that the sector is ready for an upswing. The revenue model works, innovation continues to bear fruit, and the need is ever-present. The harsh winter will result in a hearty harvest.

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Trying to get clarity on CDF and VPAS and implications for the IMF

pharmaphorum

Companies who are thinking about seeking funding via England’s new Innovative Medicines Fund (IMF) need to think through all the commercial implications, including whether spending in the IMF counts towards rebates made against sales through the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). With the IMF not yet used, but based on the Cancer Drugs Fund (CDF), Leela Barham used a freedom of information request to find out how the CDF spend is treated, and speculates as to what

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Beyond cancer: Scientists push CAR-T cell therapies into new frontiers

PharmaVoice

Why a ‘very exciting’ trial of the therapy in lupus patients could swing the door open to new studies in autoimmune diseases.

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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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Using design of experiments to optimise SEC method conditions for proteins

European Pharmaceutical Review

Proteins provide a unique challenge in robustness testing and liquid chromatographic methods development, as the profile is typically less resolved than with small molecules. As with their small molecule counterparts, traditional elements of validation are required for regulatory approval. Due to the complexity of the chromatographic profile, the elements of robustness can be particularly challenging to evaluate for methods involving antibodies.

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Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial

pharmaphorum

Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The least positive readout comes from the APPLY-PNH study, which pitted iptacopan against AstraZeneca/Alexion’s anti-C5 antibodies Soliris (eculizumab) and Ultomiris (ravulizumab) in adults with paroxysmal nocturnal haemoglobinuria (PNH), a debilitating ultra-rare blood disorder in which

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Vaccine producers promise equal access in future pandemics

European Pharmaceutical Review

Three trade bodies representing vaccine creators and manufacturers are endorsing The Berlin Declaration framework , a proposal that outlines how the industry would reserve an allocation of real-time vaccine production for swift distribution to priority populations in lower-income countries in future pandemics. The Biotechnology Innovation Organization (BIO), Developing Countries Vaccine Manufacturers’ Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associatio

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Q&A with Rocket Pharmaceutical's CTO Mayo Pujols and CEO Gaurav Shah

PharmExec

Rocket Pharmaceutical's CEO and CTO spoke with Pharm Exec about adding a new position to the company's C-suite.

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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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Sumitomo ups ante and wins support for Myovant takeover

pharmaphorum

A sweetened offer from Sumitomo Pharma has convinced endocrinology specialist Myovant to agree to a takeover, after its first was rejected. Sumitomo and its subsidiary Sumitovant Biopharma initially offered $22.75 for Myovant – which develops hormonal therapies for conditions like uterine fibroids, endometriosis and prostate cancer – but that was deemed inadequate and was turned down earlier this month.

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The Future of Being a Medical Sales Rep: What Do You Need to Know?

MedReps

Everything changes, even the medical sales industry. What began as a simple industry that sold medical products and pharmaceuticals to doctors, nurses and clinics has now become a multi-faceted business selling everything from surgical tools to biotech products. How will things continue to evolve? What types of changes do medical sales representatives have to look forward to?

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Clarify Health Recognized by Frost & Sullivan as a Healthcare Data Analytics Market Leader in 2022

Clarify Health

Clarify scores 5 out of 5 on the ‘Innovation Index,’ for its scalability, R&D efficiency, and product innovation SAN FRANCISCO, CA, October 25, 2022 – Clarify Health , a leading cloud analytics and value-based payments platform company, today announced it has been recognized by Frost & Sullivan as an industry leader in the Frost Radar TM : Healthcare Data Analytics 2022 Report.

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Accelerating New Medicines: Innovation and Technology at Curia

PharmExec

Curia is proud to partner with pharma and biotech companies to make new medicines that save lives. In order to be able to do that, Curia needs to be constantly innovating. In this podcast, you will learn from Curia’s VP of Portfolio and Sourcing, James Grabowski, about Curia’s small and large molecules most recent technologies, and capabilities.

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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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Clarify Health Recognized by Frost & Sullivan as a Healthcare Data Analytics Market Leader in 2022

Clarify Health

Clarify scores 5 out of 5 on the ‘Innovation Index,’ for its scalability, R&D efficiency, and product innovation. SAN FRANCISCO, CA, October 25, 2022 – Clarify Health , a leading cloud analytics and value-based payments platform company, today announced it has been recognized by Frost & Sullivan as an industry leader in the Frost Radar TM : Healthcare Data Analytics 2022 Report.

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Health Union Expands Leadership Team with Scott Schappell, Chief Revenue Officer, and Steve Warker, Executive VP of Product

PharmExec

Schappell and Warker join social health company Health Union to accelerate innovation and position the company for exponential growth.

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NHS to offer epilepsy patients brain laser therapy

PharmaTimes

The launch of the laser is part of the NHS’s Long Term Plan commitment

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EMC Outdoor Announces the Addition of Helen Kim as SVP of Client Services

PharmExec

Industry veteran Helen Kim has joined long-standing out of home specialist agency EMC Outdoor as senior vice president of client services.

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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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ICR scientists study cancer response to new class of drugs

PharmaTimes

The research could help determine drug responses through genetic testing

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Data Quality Imperative

Copyright Clearance Center

The post Data Quality Imperative appeared first on Copyright Clearance Center.

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PM360 2022 Trailblazer Awards Product Launch of the Year Winner GEMTESA

PM360

GEMTESA®. Urovant Sciences, Inc., Area 23, an IPG Health Company, EVERSANA INTOUCH, Slate 360, and Carbon91. Approximately 30 million Americans older than 40 experience bothersome symptoms of overactive bladder (OAB) and the prevalence increases with age. It had been nearly a decade since the last development in therapy for this life-impacting condition.

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BMS lines up follow-up indication for cardiomyopathy drug Camzyos

pharmaphorum

Bristol-Myers Squibb is going after a second indication for its first-to-market cardiac myosin inhibitor Camzyos, a drug tipped to be a future blockbuster and the top prospect in the company’s growing cardiovascular pipeline. Camzyos (mavacamten) was approved by the FDA in April to treat obstructive hypertrophic cardiomyopathy (HCM), an inherited, progressive disease that thickens the heart walls and makes it harder for the heart to expand normally and fill with blood.

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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.