Thu.Dec 29, 2022

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Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

Fierce Pharma

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42.

FDA 324
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Health Equity is Everyone’s Business; Success Requires a Strategy Rooted in Community Voice and Data

MedCity News

Our research has found that to advance ongoing work, community health ecosystems likely will need additional partners, shared goals, technology, and metrics. But most importantly, they will need the participation and leadership of more community members.

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After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena

Fierce Pharma

After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena. fkansteiner. Thu, 12/29/2022 - 09:30.

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The Importance of Quality Assurance for Customer-Centric Medical Technology

MedCity News

Having a streamlined process to get customer feedback, adhere to regulations, and automate processes not only helps make sure a business delivers the best quality products, but also helps ensure that customers are satisfied.

Medical 98
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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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Pharma manufacturing can digitalise its way round the next crisis

pharmaphorum

The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. COVID-19 erupted, mutated, and was supplemented by the challenges of monkeypox and the need to catch up with major treatment and immunisation backlogs accumulated during the pandemic. At the same time, the industry must address the long-term difficulty of providing essential medicines and health services to the high percentage of global population that c

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This Year’s 3 Most Expensive Hospital Construction Projects

MedCity News

Though hospitals’ financial circumstances were dire this year, some multibillion dollar expansion projects have managed to move forward — including a the construction of a new $5 billion medical campus in Nevada and a new $4.3 billion hospital in San Francisco.

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What Will the Pharma Industry Face in the Year Ahead?

MedCity News

Many pharma and medical device companies will look inward, with the goal of standardizing and modernizing even highly regulated activities. Here’s a closer look at some important industry trends for 2023.

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Pfizer -Openings for MSAT (Manufacturing Science & Technology)- Apply Now

Pharma Pathway

Pfizer -Openings for MSAT (Manufacturing Science & Technology)- Apply Now. Job Description. Openings for MSAT (Manufacturing Science & Technology) @ Pfizer. Keen on building your career with Pfizer!!! . Looking Female Manpower to our Pfizer Global Supply (PGS) Vizag Plant. Department: MSAT (Manufacturing Science & Technology). Functional Areas: Analytical/ Process (Technology Transfer).

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Survey: Americans Are Split on the Covid-19 Public Health Emergency

MedCity News

About 51% of U.S. adults are in favor of the Covid-19 public health emergency still in effect, while 39% said it is no longer needed, a recent Morning Consult survey found. Americans’ opinions varied based on political party, generation, race/ethnicity and location.

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Japan’s MHLW approves AstraZeneca’s Imfinzi, Imjudo for liver, lung cancers

Pharmaceutical Technology

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved AstraZeneca ’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) to treat advanced liver, biliary tract, and lung cancers. The combination of Imfinzi and Imjudo has been approved to treat unresectable hepatocellular carcinoma (HCC) in adult patients. It has also been authorised to treat unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) along with chemotherapy.

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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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A few of 2022’s biggest pharma trends – the pharmaphorum podcast

pharmaphorum

As we close out the year, pharmaphorum’s editorial team sat down together for a roundtable discussion of some of the biggest trends they tracked this year in the world of pharma. . Join editor-in-chief Jonah Comstock, founder Paul Tunnah, Deep Dive editor Eloise McLennan, and web editor Nicole Raleigh for a wide-ranging discussion touching on clinical trials, patient centricity, COVID-19’s impact on digital health, precision medicine, and artificial intelligence and machine learning. .

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The Top Personalized Medicine Stories of the Year

PharmExec

Personalized medicine continued its growth over the past year and became one of the most talked about topics in the life sciences industry.

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Novartis agrees $245m settlement over Exforge generics delay

pharmaphorum

Novartis has said it will pay $245 million to resolve civil litigation in the US which accuses it of a ‘pay for delay’ scheme involving generics of its high blood pressure therapy Exforge. The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

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Top 5 Pharmacy Times Articles in 2022

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read articles on Pharmacy Times in 2022.

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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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Berkshire Sterile Further Grows Its Instrument Collection

Pharmaceutical Commerce

With the new additions, CDMO expands its analytical testing and development services.

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December Rx Product News

Pharmacy Times

Products include a vaccine for meningococcal disease and a new type of COVID-19 test.

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A Simple Guide to Sales Pipeline Management

Spotio

Sales pipeline management is extremely important. Manage your pipeline correctly and your reps will connect with more prospects and close more deals. Mismanage your pipeline and… Well, the results won’t be nearly as favorable. But here’s the thing: managing one’s pipeline is anything but easy. That’s why we’ve put together this guide!

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Know the Ins and Outs of Medical Marijuana in the Workplace

Pharmacy Times

Both benefits and concerns exist, but implementing policies and regulations promotes employee productivity, guards safety.

Medical 49
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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.