Mon.Apr 10, 2023

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In upcoming skin disease clash, doctors see Novartis' Cosentyx as an underdog

Fierce Pharma

In upcoming skin disease clash, doctors see Novartis' Cosentyx as an underdog aliu Mon, 04/10/2023 - 15:53

Doctors 266
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A review of MALDI-TOF for microbiological identification

European Pharmaceutical Review

The high reliability of matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) mass spectrometry (MS) systems for microbiological identification offer an alternative to serological-based methods, according to a review by researchers. “New technologies for the accurate and rapid identification of bacteria are essential in various fields of applied microbiology.

Media 111
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New WHO recommendations on COVID vaccines create more revenue uncertainty: analyst

Fierce Pharma

New WHO recommendations on COVID vaccines create more revenue uncertainty: analyst kdunleavy Mon, 04/10/2023 - 10:47

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What Healthcare Organizations Should Know About Russian Hacking Gang KillNet

MedCity News

The Health Sector Cybersecurity Coordination Center (HC3) recently issued a report letting healthcare organizations know that they are still being heavily targeted by KillNet, a Russian group of cybercriminals. The number of daily attacks KillNet waged against healthcare organizations using Microsoft Azure increased significantly between November 18 and February 17 — from 10-20 attacks per day in November to 40-60 attacks per day in February.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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In legal battle over abortion pill, conflicting rulings leave future access up in the air

Fierce Pharma

In legal battle over abortion pill, conflicting rulings leave future access up in the air zbecker Mon, 04/10/2023 - 11:43

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4 Lessons Health Tech Companies Should Know to Reach $100M ARR

MedCity News

A new study from Bessemer Venture Partners analyzed more than 100 venture-backed healthcare companies to determine the best strategies to scale to $100 million in annual recurring revenue. The report laid out a few main lessons health tech companies should know, such as the importance of nurturing relationships with early customers and making sure efficiency metrics are paid close attention.

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Pear Therapeutics Files for Bankruptcy and Plans for Asset Auction in May

MedCity News

Pear Therapeutics’ Chapter 11 bankruptcy filing follows three corporate restructurings and the inability to secure additional financing to support commercialization of its FDA-cleared prescription digital therapeutics. An auction of Pear’s assets is expected to happen in early May.

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As FDA decision draws near, Sobi revamps RSV antibody deal with AstraZeneca, Sanofi

Fierce Pharma

As FDA decision draws near, Sobi revamps RSV antibody deal with AstraZeneca, Sanofi aliu Mon, 04/10/2023 - 10:37

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Malaysia approves additional indication for Astrazeneca’s Evusheld

Pharmaceutical Technology

The Malaysian Ministry of Health (MoH) has reportedly approved additional indication of Astrazeneca ’s Evusheld 100mg/ml solution for injection (Tixagevimab 100mg/ml and Cilgavimab 100mg/ml) for Covid-19 prevention. Health director-general Tan Sri Dr Noor Hisham Abdullah stated that the approval of Evusheld was granted at the 383rd Drug Control Authority (DCA) meeting.

Medicine 105
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Johnson & Johnson's $8.9B bankruptcy settlement is 'unworkable,' talc plaintiff lawyer says

Fierce Pharma

Johnson & Johnson's $8.

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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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Report: More Traditional Medicare Enrollees Are Buying Medicare Supplement Coverage

MedCity News

The share of traditional Medicare enrollees who bought Medicare Supplement coverage rose to 41% in 2021, compared to 35% in 2017, according to a report from America’s Health Insurance Plans. Medicare Supplement enrollees are three times less likely to have issues paying medical bills than those who only have traditional Medicare.

Insurance 105
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Aviceda, QUB to develop next-generation glyco-immune therapeutics

Pharmaceutical Technology

Aviceda Therapeutics (Aviceda) has entered into a strategic partnership with the Patrick G Johnston Centre for Cancer Research at Queen’s University Belfast (QUB) for the development of next-generation glyco-immune therapeutics. Aviceda’s HALOS (high-affinity ligands of sigelcs) nanotechnology platform leverages glycobiology to modulate the innate immune system to develop advanced breakthrough therapeutics, focusing on immuno-oncology.

Medicine 103
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Patient Clinical Trial & Communications Plan Review: A Customer Story

Impetus Digital

Our client reached out to Impetus to help establish a virtual patient panel with the aim to gather insights on their unmet needs, the most important attributes of treatment , and the impact of treatment on their disease burden and quality of life. In addition, they were looking for patient feedback on their recent clinical trial results, future clinical trial designs, and communications plan.

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FDA Partial Hold on Cancer Drug Adds to Molecular Templates’ Growing List of Woes

MedCity News

The FDA has asked for more information about cardiac complications reported last year in a Phase 1 study for the Molecular Templates cancer drug, MT-0169. The partial clinical hold comes as the biotech works through a corporate restructuring as well as second Nasdaq de-listing notice.

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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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Meet the Impetus Green Team

Impetus Digital

With Earth Week 2023 just around the corner, we thought it was time to officially introduce the award-winning team working behind the scenes to organize our annual Earth Week celebrations and many other sustainability initiatives ! Along with diversity, equity & inclusion (DEI) , sustainability is one of Impetus Digital’s key focus areas. We’re so proud of how far we’ve come since starting our journey in 2020.

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Hospitals and Medical Device Manufacturers Must Work Together on Cybersecurity

MedCity News

Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.

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FDA Seeking New Talent to Handle Gene Therapy Rise

PharmExec

Agency hopes to attract more seasoned expertise in manufacturing; also looking to add field inspectors.

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What Lessons Can Healthcare Learn from Other Sectors to Improve Data Quality and Collection? [Sponsored]

MedCity News

A new white paper from Intelligent Medical Objects highlights how the aviation, military, law enforcement industries and other sectors confronted data challenges to improve data collection and what the healthcare industry can learn from these examples.

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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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What to Do When You Don’t Know the Answer to Interview Questions in Medical Sales

MedReps

There’s always that moment during an interview where you find yourself without an answer to an important question. Whether the interviewer is asking about statistics (how much of a certain product have you sold in the past year?) or something more general (can you discuss a time when you had to do something that did not suit your strengths?) doesn’t matter.

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Zocdoc Adds FQHCs to Marketplace To Support Medicare, Medicaid Beneficiaries

MedCity News

Zocdoc, a healthcare marketplace, is adding Federally Qualified Health Centers (FQHCs) to its platform. Patients are now able to find and book appointments with FQHCs working with Zocdoc on the company’s website or app, and can filter based on factors like specialty and location.

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Tiny Cylinders for Controlled Drug Release

Medgadget

Researchers at Rice University have developed a new type of microparticle for drug delivery, made from a polymer called PLGA that has already been extensively explored as a component in drug delivery systems. However, what makes these new particles different is the method of loading and sealing them, which appears to give them highly tunable release characteristics and may even allow the researchers to create particles that provide multiple doses of a drug, or continuous dosing, over the space o

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Where one unicorn struggled, another biotech is aiming for a diabetes win

PharmaVoice

Intarcia looked poised to break into a lucrative diabetes implant market but has been dogged by safety issues — now Vivani thinks it’s found a way to succeed.

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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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Top Reasons Marketers Should Utilize Doctors Lists

Scott’s Directories

Are you a marketer looking to sell your services to doctors in New Brunswick? If so, a list of doctors may just be the tool you need to reach potential clients. Not only does a list give you access to information about the medical professionals in the area, but it also presents a host of other benefits that can help grow your client base. In this blog post, we’ll explore some of the top reasons why marketing teams should utilize a list of doctors in New Brunswick to sell their services.

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How To Measure Sales Productivity: 14 Metrics To Track

Spotio

According to LinkedIn, the average sales professional spends less than 30% of their time selling. Why? Simple: They’re completely bogged down by non-selling activities. Fortunately, there are a few things you can do to remedy the situation. First and foremost, you can learn how to measure sales productivity. Doing so will help you identify where your reps waste the most time and substitute those activities for more effective ones.

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What if Bill Clinton & Ronald Reagan Had Debates Universal Government Funded Healthcare? A Fictional Debate Portrayal.

Pharma Marketing Network

Bill Clinton: My fellow Americans, I stand here today to argue in favor of universal government-funded healthcare. The United States is the wealthiest country in the world, yet we have the highest number of uninsured citizens. This is not only morally wrong, but it also puts a strain on our economy. When citizens are uninsured, they are less likely to seek preventative care and more likely to delay treatment until their condition becomes severe.

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Australia lists new medicines for GVHD and chronic rhinosinusitis

Pharmaceutical Technology

The Australian Government’s Department of Health and Aged Care has announced the availability of new medicines for graft versus host disease (GVHD), chronic rhinosinusitis, and oesophageal cancer. To be provided under the Pharmaceutical Benefits Scheme (PBS), the new and updated medicines include Jakavi (ruxolitinib), Nucala (mepolizumab), and Opdivo (nivolumab).

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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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Clovis Divests Remaining Assets, Including Rubraca Cancer Drug, for Over $70 Million

PharmExec

Bankrupt Clovis Oncology offloads assets, including ovarian cancer drug Rubraca, to Swiss firm Pharma& Schweiz for over $70 million.

Pharma 52
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India’s Cipla signs licence deal with Novartis for diabetes drug Galvus

Pharmaceutical Technology

India-based pharmaceutical company Cipla has entered into a perpetual licence agreement with Swiss drugmaker Novartis Pharma for the diabetes drug Galvus and its combination brands. Under the deal, Cipla will be responsible for the manufacturing and marketing of Galvus and its combination brands from 1 January 2026. Galvus brand products are mainly used in the treatment of patients with type 2 diabetes.

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FDA Regulatory Authority Under Attack

PharmaTech

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

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Cambrex Unveils Belgian Stability Storage Facility

Pharmaceutical Commerce

Demands for services in this sector have increased since last year’s Q1 Scientific acquisition, CDMO says.

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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.