Fri.Feb 09, 2024

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Novo Nordisk settles with 2 Florida sellers of compounded Ozempic

Fierce Pharma

Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday. | Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday.

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Moderna & Ionis-Partnered Biotech Lands $94M in IPO Cash for Gene-Editing R&D

MedCity News

Metagenomi finds novel gene-editing tools by mining microbial samples from around the world. Already partnered with Moderna and Ionis Pharmaceuticals, the company said its IPO cash will support ongoing preclinical research.

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As cancer drug shortages persist, ASCO official urges congressional action at hearing

Fierce Pharma

A year into a dire shortage of essential cancer medicines in the U.S., the American Society of Clinical Oncologists (ASCO) is again pushing Congress to act to end the crisis. | The oncology drug supply crisis has entered its second year, and doctors still face "impossible choices" without access to standard-of-care therapies, ASCO's chief medical officer, Dr.

Doctors 242
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Everly Health Partners With National Kidney Foundation, Expands Kidney Health Testing Suite

MedCity News

Everly Health has formed a partnership with the National Kidney Foundation to improve education about chronic kidney disease. It has also expanded its diabetes monitoring and kidney health testing suite for health plans and employers.

Education 109
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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As Catalent prepares to join Novo family, CDMO's sales continue to slide

Fierce Pharma

As Catalent gets ready to join the Novo fold, the contract manufacturing juggernaut continues to slide on its diminishing COVID-19 business. | Despite some turbulence at Catalent, including an 11% sales drop for the quarter, investors still seem to be buzzed about the stock after this week’s announcement that Novo Holdings is buying out the CDMO for $16.5 billion.

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Limiting Cyberattack Blast Radius for Healthcare SaaS

MedCity News

From our experience providing identity management services to healthcare SaaS companies, here are five rules for building more secure SaaS applications. The list can serve as a guide either for healthcare organizations looking to move key operations to SaaS or to makers of SaaS applications for healthcare customers.

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Brain Patterns, Physiological Metrics Show VR’s Ability To Reduce Chronic Pain In New Research

MedCity News

AppliedVR released study results demonstrating VR’s ability to help patients suffering from chronic low back pain. The technology was able to increase participants’ brain coherence and help them achieve a slower breathing rate — two metrics associated with reduced pain.

Patients 108
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Drug/software combination improves blood pressure control

pharmaphorum

The combination of drugs for hypertension and software to personalise dosing to an individual patient has been shown to deliver improved blood pressure control and adherence to therapy in a pilot study.

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Contrasting Provider-To-Consumer vs Direct-To-Consumer Healthcare Model

MedCity News

With the PTC model, providers can remain independent, continue “driving the bus,” generate revenue for their practice, treat more patients virtually and scale their practice like never before.

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What Goes into Planning LogiPharma Europe?

Pharmaceutical Commerce

A dive into the intricacies of how to ensure a long-running event stays fresh and relevant to the needs of the pharmaceutical industry.

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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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Tech-Enabled Biology: Pioneering a New Era in Biotechnology

MedCity News

The new era of full-stack compute-enabled bio companies will drive incredible advances in human health.

Biopharma 129
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US Senate committee interrogates big pharma on “outrageously high” drug prices

Pharmaceutical Technology

Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.

Pharma 113
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Astellas’ science chief on the leap into new technologies

PharmaVoice

After a big 2023, Yoshi Shitaka said the company is banking on gene therapies, KRAS degraders and more to keep the momentum.

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AstraZeneca posts 81% rise in FY 2023 profit after tax

Pharmaceutical Technology

AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for FY 2023 from $3.29bn in the previous year.

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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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Researchers identify new treatment target for genetic epilepsy

PharmaTimes

The rare neurodevelopmental condition CDKL5 is characterised by early-onset epilepsy

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Boehringer and CBmed partner to develop cancer therapies

Pharmaceutical Technology

Boehringer has entered a strategic collaboration with CBmed to expedite the translation of cancer treatment approaches into new therapies.

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EMA Accepts Three Organizations into ATMP Pilot Program

PharmaTech

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

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Vicore licenses idiopathic pulmonary fibrosis therapy to Nippon in Japan

Pharmaceutical Technology

Nippon will pay $10m upfront and up to $275m in milestone-based payments for the developmental and commercial rights to Vicore’s C21 in Japan.

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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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StartUPDATES: New Developments for Healthcare Startups

MedCity News

Check out news from Health Wildcatters, Rivia Health, Apella, and more.

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Royal Marsden to implement RaySearch’s online adaptive radiation therapy system

PharmaTimes

OART is increasingly emerging to assess and adapt treatment for cancer patients

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Impetus Digital: now working from carbon-neutral offices

Impetus Digital

At Impetus, we’re serious about our commitment to the planet. We have been planting trees across Canada and actively working towards reducing our emissions and reaching carbon neutrality since 2021. As a relatively small company, with no dedicated Sustainability Officer, we are taking a phased approach to becoming carbon-neutral by 2030. We’re excited to share that Phase 1 has officially been implemented!

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Samgsung Biologics Announces Partnership With LegoChem Biosciences to Advance Development of Antibody-Drug Conjugates

Pharmaceutical Commerce

New collaboration seeks to take a significant step in the development of targeted treatments for solid tumors and an expansion of opportunities in the growing antibody-drug conjugate market.

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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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Synlogic shuts down after PKU drug fails phase 3 trial

pharmaphorum

Synlogic has slashed nearly all its staff and launched a strategic review after its lead drug for rare disease phenylketonuria failed a phase 3 trial

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The Promise and Peril of AI in the Physical World

PharmExec

The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.

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Novo to buy Catalent: the backlash begins

Pharmaceutical Technology

Novo Nordisk’s plans to buy Catalent has raised objections related to the risk of drug shortages, manufacturing standards, and antitrust violations.

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BioNTech and Autolus Announce Strategic Alliance to Bolster CAR-T Cell Pipeline

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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BioNTech partners with Autolus to advance CAR-T therapies

Pharmaceutical Technology

BioNTech has entered into a strategic partnership with Autolus Therapeutics to progress the development of CAR-T cell therapy programmes.

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How to Stand Out in the Wellness Space as a Pharma Brand

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

Pharma 52
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Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Pharmaceutical Technology

The Phase I trial for evaluating Hemogenyx’s CAR-T therapy to treat acute myeloid leukaemia has been cleared to begin in the US.

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Let’s Not Forget the Silent Killer: Hypertension

Pharmacy Times

The prevalence of hypertension continues to increase amongst adults in the United States, leading to other cardiovascular conditions. Lifestyle changes and medication adherence are essential for appropriate hypertension management.

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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.