Wed.Nov 02, 2022

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AMA: CMS’ 2023 Physician Fee Schedule Would Create ‘Financial Instability’

MedCity News

The 2023 Physician Fee Schedule conversion factor — which calculates how much a physician is reimbursed by Medicare for services — changed to $33.06, a $1.55 decrease from 2022 at $34.61. The American Medical Association strongly opposes the cuts.

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“Universal” CRISPR-edited T cells improve resistant leukaemia

European Pharmaceutical Review

Researchers at Great Ormond Street Hospital for Children (GOSH) and University College London (UCL) Great Ormond Street Institute of Child Health (UCL GOS ICH) have used “universal” CRISPR-edited cells in humans for the first time to treat B-cell acute lymphoblastic leukaemia (B-ALL) child patients with engineered donor T cells. The treatment did not require matching donor cells, a major step in developing gene-edited cells for cancer treatment.

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Could digital therapeutics provide a solution against opioid abuse?

pharmaphorum

Digital therapeutics are rapidly coming into the foreground to treat a variety of conditions. Ben Hargreaves discovers how chronic pain could be a key area for digital therapeutics, as they offer non-addictive and effective relief from the condition. The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium.

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Alkermes Weighs Splitting Off Cancer Biz as Separate, Publicly Traded Company

MedCity News

Alkermes says separating cancer from its portfolio and pipeline of neuroscience products could put the company on a path to profitability. Meanwhile, the new cancer company would be an independent and publicly traded entity with a lead immunotherapy in pivotal testing for two types of cancer.

Leads 121
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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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Pfizer records 6% decline in revenue in Q3 2022

Pharmaceutical Technology

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

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Rubius’s New Cell Therapy Strategy Runs Out of Time & Money; Workforce Is Cut by 82%

MedCity News

Rubius Therapeutics was unable to secure financing to carry out its pivot to a new manufacturing process for its red blood cell-based cell therapies. The once high-flying biotech is now exploring options that could include a sale of the business or a merger with another company.

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CVS, Walgreens Will Pay $10 Billion Total To Settle Opioid-Related Lawsuits

MedCity News

The settlement terms are still being negotiated and the final settlement depends on the number of states, counties, and Native American tribes that agree to join.

Biopharma 121
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Johnson & Johnson to Acquire Heart Pump Maker Abiomed

Legacy MEDSearch

Johnson & Johnson, the world’s largest, most diversified healthcare products company, and Abiomed, a world leader in breakthrough heart, lung and kidney support technologies, announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire through a tender offer all outstanding shares of Abiomed, for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion which includes cash acquired.

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Carta Healthcare Rakes in $20M with Hopes of Selling its Tech to More Hospitals

MedCity News

Carta Healthcare recently closed a $20 million Series B financing round. , The company is a San Francisco-based provider of clinical data solutions, and its mission is to reduce the amount of time clinicians spend on mundane administrative tasks. Carta’s technology is currently used at 245 hospitals across 18 health systems — the company will use its new funds to scale its customer base.

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Woman of the Week: City of Hope’s Gulden Mesara

PharmaVoice

Charged with bridging the 100-year-old research center to its future mission of holistic patient cancer care, Mesara is bringing decades of experience in communications and culture creation.

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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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Startup Founded by Brown Undergrads Raises $14M to Improve Care for Vulnerable Seniors

MedCity News

Intus Care, a predictive analytics platform designed to improve care outcomes among geriatric patients, recently closed a $14.1 million Series A funding round. The startup’s mission is to improve the way PACE programs use their data so they can maintain and enhance the quality of care they provide to vulnerable seniors.

Patients 112
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How Europe’s energy crisis is impacting pharma

PharmaVoice

Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

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Connecting Health Systems and Life Science Researchers To Maximize the Potential of Real-world Evidence.

MedCity News

There needs to be a bigger emphasis and move towards connecting the life science companies who are doing the work of using biomarkers to develop therapies with the health systems where a majority of cancer care in the US actually occurs. Not enough patients are getting the benefit of precision medicine today. It starts with data sharing and real world evidence.

Medicine 108
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$8 million grant awarded to new US stem cell clinic

European Pharmaceutical Review

Cedars-Sinai has been awarded an $8 million grant over five years by the California Institute for Regenerative Medicine (CIRM) , a US stem cell agency, to launch Alpha Stem Cell Clinic, intended to increase research and training in regenerative medicine, improve collaboration with eight similar Californian clinics and offer patients wider access to stem cell and gene therapies.

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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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The 2 Things That Made My Transition to Voice Tech Easier: A Friendly Pricing Model and Easy Implementation

MedCity News

Voice-enabled technology powered by AI reduces documentation time by several hours per week, but physicians won’t adopt a solution unless it’s affordable and intuitive.

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Pharmacy chains agree $10bn settlement in opioid litigation

pharmaphorum

CVS Health and Walgreens have become the first two US pharmacy chains to agree a settlement worth nearly $10 billion to answer allegations they played a role in the opioid epidemic that has claimed tens of thousands of lives. CVS and Walgreens both said that the agreements in principle could resolve all the opioid-related lawsuits they are facing from states, subdivisions and Native American tribes.

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Streamlining Equipment Quality and Flexibility

PharmaTech

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.

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After Haleon spinoff, GSK raises forecasts on ‘strong’ Q3

pharmaphorum

In its first set of quarterly results since it separated from its consumer health business, GSK has exceeded analysts’ estimates, with a healthy rise in revenue and profit driven by shingles vaccine Shingrix. The UK pharma group – now a therapeutics and vaccines pure-play since the spin-off of Haleon in July – also raised its financial forecasts for the full year for the second time in consecutive quarters, as third-quarter revenues climbed 18% to £7.8 billion (around $8.9 billion) against

Sales 82
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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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Scale-up and Tech Transfer: From Development Lab Studies to Commercial Production

PharmaTech

Adherence to detail and thorough project management are required for successful tech transfer and scale up.

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Anthropy 2022 – Day One

pharmaphorum

Wednesday 2 nd November heralds the start of Anthropy 2022 at The Eden Project. With pharmaphorum fully in attendance today, expect coverage of a wide range of topics, within a variety of formats, all united by a shared goal of seeking sustainable change for Britain, whilst bearing in mind her role upon the global stage at this critical juncture in history.

Pharma 81
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Aelix and Gilead announce results of HIV infection candidate

PharmaTimes

The study evaluated the safety, efficacy and immunogenicity of AELIX’s HIV vaccine

Safety 103
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Norstella, Citeline merge to create $5bn pharma tech firm

pharmaphorum

Citeline and Norstella have completed a merger, first announced in June, to create one of the largest players in the pharmaceutical intelligence category. Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

Pharma 76
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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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J&J to Acquire Abiomed for $16.6 Billion

PharmaTech

Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.

Medical 75
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Everything Genetic links up with Caris for UK distribution of MI Tumor Seek

PharmaTimes

MI Tumor Seek is a molecular profiling service used to guide the management of advanced cancer

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EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine

Pharmaceutical Technology

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU). The latest approval comes after adequate data on safety and efficacy validating the vaccine’s benefits was available.

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The Role of CoAs in Supplier Oversight

PharmaTech

Industry experts discuss best practices for certificates of analysis.

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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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China’s biopharma industry: the small molecule renaissance in rare diseases

Pharmaceutical Technology

Small molecule approvals are on the decline in China. According to GlobalData’s Drugs Intelligence Database, from 2020 to 2022, the number of innovator small molecule approvals in China shrank by 21%. However, over the same period, approvals for innovator small molecules treating rare diseases rose by 22%, giving hope to rare disease patients. According to the GlobalData’s Drug Database, the number of innovator small molecule approvals for rare diseases rose steadily over three years, from three

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Highlights From CCC’s OA Innovation Seminar Series

Copyright Clearance Center

The post Highlights From CCC’s OA Innovation Seminar Series appeared first on Copyright Clearance Center.

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How a hydrogen peroxide catalyst could contribute to optimize the technology and its aeration process

PharmaTech

This article proves the viability of including a catalyst in a nebulized hydrogen peroxide recirculated system and the low impact in complete cycle times.

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How to Effectively Target Sales to Doctors

Scott’s Directories

Doctors are an important demographic for any business looking to increase their sales. When targeting doctors, it’s essential to understand their needs and be able to effectively communicate your product or service as a solution. In this blog post, we’ll cover some of the best ways to target sales to doctors with the help of an online medical database.

Doctors 52
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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.