Tue.Jan 30, 2024

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Amid strategic pivot, 2seventy bio plots comeback for BMS-partnered CAR-T Abecma

Fierce Pharma

2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. | 2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. Now, the company is splitting in two once again, passing its R&D programs to Regeneron and going all-in on its Bristol Myers Squibb-partnered CAR-T Abecma.

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Charting a course for ongoing omnichannel excellence

Dominic Tyer

Successful customer engagement will require pharma companies to maintain a rigid focus throughout the journey

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Trending Sources

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FDA rejects Defender Pharma's motion sickness nasal gel candidate

Fierce Pharma

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. | A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion.

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How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer

MedCity News

Even just a year ago, we couldn’t fathom a cure for cancer. Now, we can. Artificial intelligence (AI) is rapidly transforming the healthcare industry, with its ability to process and analyze vast amounts of data. Cancer treatment is one area that could benefit significantly from AI, as it can aid in early detection, precise diagnosis, and personalized treatment plans.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

Fierce Pharma

After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

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ViVE 2024: Optimizing Provider and Payer Meetings [Sponsored]

MedCity News

A preview of ViVE 2024 offers a sneak peek at the agenda and how the Payer and Provider Connect meeting platform initiatives have been revamped to maximize the quantity and quality of meeting for healthcare executives.

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Alternative Therapies for Pain Management in Senior Care

MedCity News

Chronic pain, an enduring concern for many older adults, is no longer confined to the traditional realm of pharmaceuticals. While traditional pain management methods like medication were once the go-to approach, alternative therapies are emerging as a viable and holistic approach to addressing this issue.

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US bill paints some Chinese biotechs as security threats

pharmaphorum

Legislation filed in the US is seeking to block Chinese biotech companies from federal contracts on the grounds they are a national security concern

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Beyond The Traditional KOL: 3 Reasons Pharma Should Tap Nurses as Change Agents

MedCity News

As key opinion leaders (KOLs), nurses can provide insights on unmet clinical needs, identify gaps in treatment options, and contribute to the development of better and more patient-centric solutions. Here are three core reasons why pharmaceutical companies should tap the power of nurses.

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Digital prescriptions added to NHS App

pharmaphorum

From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.

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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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Regeneron Acquires Cancer Drug Pipeline, Creates New Cell Therapy Division

MedCity News

Regeneron Pharmaceuticals is paying $5 million up front for 2seventy bio’s cancer drug pipeline. 2seventy will now focus on a cell therapy commercialized with partner Bristol Myers Squibb while Regeneron adds assets for its newly formed cell therapy division.

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CHMP meeting highlights: January 2024

European Pharmaceutical Review

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week. The CHMP recommended Exblifep (cefepime/enmetazobactam) as a treatment for complicated urinary tract infections, including pyelonephritis, hospital-acquired pneumonia, including ventilator associated pneumonia, and for treating bacteraemia caused by the aforementioned infections.

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RTLS and Workflow Automation Reduce Clinical Administrative Tasks to Benefit Outcomes

MedCity News

Proven to offer cost-effective solutions, Real-Time Location Systems (RTLS) can ease operational burdens for efficiency and enhance the relationship between patients and caregivers, enabling a more human-focused experience for all.

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Immunotherapy drug achieves trial-first in fifty years

European Pharmaceutical Review

Results from a Phase III, randomised, placebo-controlled clinical trial have for the first time in fifty years, demonstrated an overall survival benefit from an adjuvant therapy in kidney cancer. Pembrolizumab targets a “checkpoint” pathway that is key in enabling cancer cells to avoid being destroyed by the immune system. As a result, the immunotherapy drug supports the immune system’s T cells fight tumours, the researchers highlighted.

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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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MedCity Pivot Podcast: Affordable Surgical Robotics with Anne Osdoit

MedCity News

Anne Osdoit, CEO of Moon Surgical, explains how the Maestro System may be expanding the surgical robotics pie by bringing the capability to newer markets and how surgical robotics do not have to break the bank.

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GSK seeks to extend RSV vaccine use in adults aged 50-59

Pharmaceutical Technology

The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.

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MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Kristin Myers, Chief Digital Officer at Northwell Health

MedCity News

For the first episode of 2024, Senior Reporter Katie Adams discussed some executive hires, promotions and departures that recently took place in the healthcare world, as well as layoffs affecting the industry. We also hear from Kristin Myers, who recently became Northwell Health’s first chief digital officer.

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Vertex aims for approval after Phase III win with non-opioid pain reliever

Pharmaceutical Technology

Vertex is planning to submit a new drug application to the FDA following the announcement of its Phase III programme meeting its primary endpoint.

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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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Blue Shield of California Plan Helps Members Earn GED Diploma

MedCity News

Blue Shield of California Promise Health Plan is working with the GED Testing Service to help members earn a General Educational Development (GED) diploma for no cost. Members can register online and gain access to GED study materials in both English and Spanish.

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First human subject receives a Neuralink brain implant

pharmaphorum

Elon Musk’s Neuralink company has said it has implanted its wireless brain implant device into a human being for the first time

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New Startup Launches To Bring VBC to Endocrinology Practices

MedCity News

Valendo Health, the newest startup built at Redesign Health, launched on Tuesday. The startup partners with independent endocrinology practices and provides technology to help them thrive in value-based care arrangements.

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International consortium identifies biomarkers for cardiovascular disease in diabetes

PharmaTimes

Type 2 diabetes is estimated to affect 462 million people worldwide

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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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Vertex scores double win with non-opioid pain drug

pharmaphorum

Vertex Pharma says its much-anticipated non-opioid painkiller, VX-548, clears two phase 3 trials en route to an FDA filing later this year

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People with chest pain more likely to develop heart and circulatory diseases

PharmaTimes

Around one million adults in the UK visit their GP every year due to chest pain

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CAR-T developers respond to FDA black box warning

PharmaVoice

Despite a recent safety warning from the FDA, companies such as BMS and J&J stress that the benefits of their cancer therapies still outweigh the risks.

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Nitrosamines, Elemental Impurities, Extractables, and Leachables: The Pharma Industry’s New Normal

PharmaTech

Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.

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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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Pharma To Med Device Sales Transition With The Medical Sales Career Builder Program With Aaron Kopfinger

Evolve Your Success

Are you on the cusp of transitioning to a career in medical device sales but uncertain about the steps to take? This episode could inspire you to finally embark on that transformative journey. Samuel Adeyinka sits down with Aaron Kopfinger , who shares his remarkable journey from pharma to a thriving career in medical device sales. A graduate of the Medical Sales Career Builder Program, Aaron unveils the challenges he faced, the pivotal moments that led him to pursue a change, and the impactful

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Drug Solutions Podcast: The Biosimilars Landscape

PharmaTech

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

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A Behind-the-Scenes Look at Drug Price Markups

Pharmaceutical Commerce

New England Journal of Medicine study provides a breakdown of how hospitals—especially those that qualify for discounts under the federal 340B Drug Pricing Program—are able to make a profit off insurer pharmaceutical expenditures.

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Drug Digest: : Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

PharmaTech

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

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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.