Mon.Jul 11, 2022

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Vertex builds up pipeline of type 1 diabetes cell therapies with $320M buyout

MedCity News

Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets and technologies. The two companies already share a partner in common: both have therapeutic candidates that use the gene-editing capabilities of CRISPR Therapeutics.

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Why a 'fundamental shift' in regulatory submissions is on the way

PharmaVoice

Deloitte's senior manager of R&D and regulatory practices explains how technology and strategy must converge to smooth out the bulky drug approval process.

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How proactively addressing social determinants of health (SDOH) can drive better outcomes, lower healthcare costs

MedCity News

With proactive outreach by highly trained community health navigators guided by data and leveraging easy-to-use technology, we could get ahead of an individual’s needs, design and execute a care plan, and – hopefully – keep them out of the hospital.

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Supply chain & logistics innovation among pharma companies has dropped off in the last year

Pharmaceutical Technology

Research and innovation in supply chain & logistics in the pharmaceutical sector has declined in the last year. The most recent figures show that the number of supply chain and logistics related patent applications in the industry stood at 17 in the three months ending May - down from 21 over the same period in 2021. Figures for patent grants related to supply chain and logistics followed a similar pattern to filings - shrinking from 2 in the three months ending May 2021 to 1 in the same per

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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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Roche pays $55M for late-stage drug for rare kidney disease with no approved treatment

MedCity News

An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the molecule. The pharmaceutical giant gets a contender in the chase to win the first regulatory approval of a therapy for this rare kidney disease.

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Getting Started With Google Analytics 4 for Healthcare Brands

Healthcare Success

Google Analytics is an extremely powerful tool for healthcare businesses. According to BuiltWith, more than 28 million websites use Google Analytics to better understand how users engage with their web properties—including more than 66% of the top 100,000 websites worldwide. The development and subsequent launch of Google Analytics 4 (GA4) in October 2020 was spurred by a 2018 ruling of Europe’s General Data Protection Regulation (GDPR) , the strictest data privacy and security law in the world.

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Study highlights the multibillion dollar burden of rare disease

pharmaphorum

Annie Kennedy, chief of policy, advocacy, and patient engagement at the EveryLife Foundation for Rare Diseases, tells us why the Foundation sponsored The National Economic Burden of Rare Disease Study, undertaking the challenge of examining the financial impacts of rare diseases. In 2018, the Foundation and its partners elected to perform The National Economic Burden of Rare Disease Study when it recognised that little data existed on who was living with rare diseases and what cost barriers were

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How one company has moved to support reproductive rights despite looming regulatory uncertainty

MedCity News

The reversal of Roe v. Wade led Forma to make a series of changes to its reproductive health benefits on top of what it originally offered — both for its internal employees and its customers.

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Aurobac Therapeutics launched to fight antimicrobial resistance

European Pharmaceutical Review

Headquartered in Lyon, France, Aurobac Therapeutics aims to develop a new precision medicine approach to antibiotic treatment , from diagnosis to cure. The joint-venture is majority-funded by Boehringer Ingelheim (€30 million), with life science company Evotec and diagnostics specialist bioMérieux contributing €5 million each. . ”Antibiotic resistance kills about 1.27 million people globally every year and it has been estimated that by 2050, as many as 10 million worldwide deaths could result fr

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Report: Female physicians are much more aware of medicine’s gender discrimination than male physicians

MedCity News

Gender discrimination is felt much more in women physicians than it is in men, according to a new report. It found that two-thirds of the female physicians have experienced gender discrimination from a medical colleague, and 57% of them have experienced it from a patients. These numbers were 30% and 19%, respectively, for male physicians.

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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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AI-powered smartphone app monitors IBS using poo images

pharmaphorum

Researchers in the US have developed an app that uses a smartphone camera and artificial intelligence algorithms to assess images of patients’ poo for signs of disorders like irritable bowel syndrome (IBS). The tool is intended as an alternative to patients’ self-reporting stool form and frequency using the seven-point Bristol Stool Scale (BSS), which ranks consistency from hard to liquid but can produce highly variable results.

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Tebra raises $72M to scale its operating system for independent practices

MedCity News

Tebra, a company that sells software to independent physician practices, announced it has raised more than $72 million and reached a valuation greater than $1 billion. The company, which formed last year as a result of a merger between PatientPop and Kareo, will use the funding to advance its platform and scale its sales and marketing teams.

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A Comprehensive Guide to a Structured Interview

MedReps

Recruiters in the medical sales industry use a number of different types of interviews in order to narrow down candidates. One of these is the structured interview. Designed to help interviewers not only with the interview but also with choosing candidates, this is one of the interview methods that you may face when searching for your dream job in the medical sales industry.

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Behind the new topical treatment set to disrupt the psoriasis market

PharmaVoice

Phil Brown, Dermavant’s chief medical officer, discusses VTAMA — the first topical cream approved for psoriasis in 25 years.

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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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Novo Nordisk release results from haemophilia treatment study

PharmaTimes

Data shows a significant reduction in treated spontaneous and traumatic bleeds among haemophilia patients

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Vertex buys diabetes cell therapy rival ViaCyte for $320m

pharmaphorum

Vertex has doubled down on cell-based therapies for type 1 diabetes (T1D), buying ViaCyte in a $320 million deal that it says will accelerate development of its own candidate VX-880. The deal has been announced just a few days after the FDA lifted a clinical hold on a phase 1/2 trial of VX-880 – a stem cell therapy Vertex acquired through its near $1 billion acquisition of Semma in 2019 – because the FDA wanted to see additional data before allowing the dose to be increased.

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Innoviva enters agreement to acquire La Jolla Pharmaceutical Company

Pharmaceutical Technology

Innoviva has signed a definitive merger agreement for the acquisition of all of the outstanding shares of La Jolla Pharmaceutical Company for $6.23 for each share in cash or an enterprise value of nearly $149m. As per the deal, Innoviva will acquire La Jolla through its wholly-owned subsidiary. La Jolla focuses on marketing innovative treatments that can enhance outcomes in patients with life-threatening diseases.

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Sanofi and Sobi present effective bleeding treatment

PharmaTimes

Data demonstrates that efanesoctocog alfa provides superior bleed protection

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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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FDA expands approval for Horizon’s Krystexxa for uncontrolled gout

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the supplemental Biologics License Application (sBLA) of Horizon Therapeutics for the Krystexxa (pegloticase) injection, given along with methotrexate, to help uncontrolled gout patients attain a complete response to treatment. The label expansion for Krystexxa plus methotrexate is based on the data from the randomised, controlled MIRROR clinical trial in adults with the condition.

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Wild Cards, a New Brainstorming App from PRECISIONeffect, Released

PharmExec

Generating an actual brainstorm is elusive. Every marketer, strategist, creative person in every industry has probably seen far more of the opposite.

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Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method

PharmaTech

Tuesday, July 12th, 2022 at 11am EDT|8am PDT|4pm BST|5pm CEST Dr. Meike Römer from Grünenthal Pharma, Germany, presents the company’s approach for the evaluation and implementation of transmission Raman spectroscopy for pharmaceutical content uniformity testing.

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POCN Welcomes New SVP of Community Strategy and Network Growth, Allison Bagin Kenah

PharmExec

Kenah joins the leadership team with 18 years of program management, marketing, and customer engagement experience in the healthcare industry, including for WebMD and SonderMind.

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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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Proposed Changes to Remote Therapeutic Monitoring Reimbursement in the Proposed 2023 Medicare Physician Fee Schedule

Nixon Gwilt Law

Every summer when the Centers for Medicare and Medicaid Services (“CMS”) releases the Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Nixon Gwilt Law (“NGL”) team excitedly opens the two-thousand-something-page PDF and immediately keys “ctrl+F” (or command+F for us Mac users) to jump to our most anticipated section(s). This year, “Remote Therapeutic Monitoring” is where we started!

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Q&A With Bryan Kobel, CEO, TC BioPharm

PharmExec

Kobel discusses taking a company public during a challenging time in the market.

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Mid-Year Product Release? Here's How to Nail it.

Modus

You feel the momentum pumping in the air. The product development team has spent hours refining and fine tuning. The customer service team has been trained to answer questions and issues. The entire team is together, aligned, and rallying. Spirits are high. That’s right , it’s mid-year product release season.

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Samsara Vision Announces First U.S. Surgeries of the SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), for Age-Related Macular Degeneration as part of the CONCERTO Study

Legacy MEDSearch

Samsara Vision , a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, announced the completion of the first U.S. surgeries of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.

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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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Digital media hiring levels in the pharmaceutical industry rose in June 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for digital media related positions rose in June 2022 compared with the equivalent month last year, with 49.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 41.4% of companies who were hiring for digital media related jobs a year ago and an increase compared to the figure of 43.1% in May 2022.

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Sanofi trumpets data with haemophilia treatment duo at ISTH

pharmaphorum

Sanofi R&D in its core haemophilia category is advancing on three fronts – engineered proteins, RNA interference drugs and gene therapies – and highlighted results in two of those at the International Society on Thrombosis and Haemostasis (ISTH) congress over the weekend. First up is Alnylam-partnered RNAi candidate fitusiran , an antithrombin-targeting agent in development as a treatment for haemophilia A and B with as few as six injections per year, making it a potential rival to RocheR

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North America is seeing a hiring boom in pharmaceutical industry IoT roles

Pharmaceutical Technology

North America extended its dominance for internet of things (IoT) hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 56.4% of total IoT jobs - up from 55.1% in the same quarter last year. That was followed by Europe, which saw a 1.1 year-on-year percentage point change in IoT roles.

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NICE makes J&J’s Tremfya more accessible in England and Wales

pharmaphorum

NICE has updated its recommendations for NHS use of Johnson & Johnson’s IL-23 inhibitor Tremfya in the treatment of psoriatic arthritis (PsA), expanding the pool of patients eligible for treatment with the drug. The health technology assessment (HTA) organisation initially recommended Tremfya (guselkumab) as a treatment option for adults with active psoriatic arthritis last year, but limited it to patients with moderate-to-severe psoriasis symptoms.

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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.