Fri.Sep 01, 2023

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Amgen's $28B Horizon buyout cleared for takeoff after FTC, states settle

Fierce Pharma

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. | Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address “the potential competitive harm” that could result from the merger deal. Now, Amgen is free to go forward with its $28 billion buyout.

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Data Access and Equity: How Secure Engagement Data Sharing Makes for Healthier Patients

MedCity News

The fusion of clinical and engagement data can revolutionize the way we understand and treat patients. By optimizing data collection and synthesis, securely sharing data, and ensuring equitable access, we can make significant strides towards delivering more personalized, effective, and patient-centered care.

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Bayer bets big on Kerendia's potential to treat heart failure

Fierce Pharma

Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. | Bayer plans three new trials to assess its potential blockbuster medicine Kerendia in heart failure. The drug was first approved 2 years ago in CKD associated with diabetes.

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What Do Value-Based Care Startups Need to Do to Attract Investors?

MedCity News

As the value-based care market gets more crowded, startups in this space will have to nail down the fundamentals in order to attract capital from investors, healthcare business expert Paul Campbell said during a virtual conference. He encouraged startups to be crystal clear about what their value proposition is for three main stakeholders — patients, providers and payers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Following in Tecentriq's footsteps, Alecensa gives Roche another win in early-stage lung cancer

Fierce Pharma

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. | After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa.

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Amgen, FTC Settlement Allows $28B Horizon Acquisition to Move Forward

MedCity News

Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.

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Bicycle Health, Albertsons Form Partnership To Expand Access to OUD Treatment

MedCity News

Through a new partnership, Bicycle Health providers can prescribe patients buprenorphine extended release injections (otherwise known as Sublocade), which can be administered by a pharmacist at an Albertsons pharmacy.

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Intelligent OMICS partners with Janssen on AI-driven research

PharmaTimes

The AI platform and expertise will be combined to discover novel targets for haematological cancers - News - PharmaTimes

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A startup’s psychedelic delivery tech is grabbing attention. Will pharma listen?

PharmaVoice

Psycheceutical is developing a back-of-the-neck topical treatment for ketamine but believes the delivery route holds promise for far more drugs.

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Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Pharmaceutical Technology

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

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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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$2 billion mRNA-based oncology therapy market anticipated by 2029

European Pharmaceutical Review

The global mRNA-based oncology therapy market is expected to reach $2 billion by 2029, according to GlobalData. BioNTech is anticipated to lead the market with a predicted $885 million in sales, and a 44.6 percent share by 2029, the research has shown. Global mRNA-based oncology therapy market At present, the pharmaceutical industry is still awaiting the first regulatory approval of an mRNA-based oncology therapy. mRNA stability and delivery specificity are two of the main obstacles hindering pr

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Otsuka Pharmaceutical agrees to buy Mindset Pharma

Pharmaceutical Technology

Otsuka Pharmaceutical has signed a definitive arrangement agreement to acquire Mindset Pharma, in an all-cash deal worth C$80m ($59.1m).

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Twist Bioscience and Ono Pharmaceutical collaborate

PharmaTimes

Partnership will discover and develop novel antibodies for a range of autoimmune diseases - News - PharmaTimes

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The changing of the guard is expected in the Crohn’s disease marketplace

Pharmaceutical Technology

As per GlobalData, AbbVie has remained the Crohn’s disease market leader over the last five years, with Humira sales of $2.7bn in 2022 in 8MM.

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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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Trial-first for Roche lung cancer ALK inhibitor

European Pharmaceutical Review

Roche’s Alecensa ® (alectinib) is the first anaplastic lymphoma kinase (ALK) inhibitor to demonstrate a reduction in the risk of disease recurrence or death for patients with early-stage ALK-positive non-small cell lung cancer (NSCLC) in a Phase III trial. The Phase III ALINA study compared Alecensa to platinum-based chemotherapy. Results from the trial “provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant u

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Roz Brewer announces sudden departure as CEO of Walgreens

PharmaVoice

The exec who set out to overhaul the long-time pharmacy giant offered few details on why she's stepping down.

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The Enterprise Potential of ChatGPT for Digital Health

Nixon Gwilt Law

The buzz around ChatGPT, steady for the last year, continues to build. With OpenAI’s upcoming launch of ChatGPT Enterprise, digital health leaders should pay close attention to the opportunities this groundbreaking technology could unlock for their organizations. So what exactly is ChatGPT Enterprise and why does it matter? Let’s explore how this powerful large language model (LLM) could transform digital health solutions when tailored to industry-specific use cases.

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Reset Pharma partners with Filament to license psilocybin drug

Pharmaceutical Technology

Reset Pharma has entered a licensing agreement with Filament for psilocybin drug PEX010, designed for treating demoralisation syndrome.

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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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SGLT2 Inhibitors Not Associated With Improved Survival in Patients Hospitalized With COVID-19

Pharmacy Times

In a previous trial, DARE-19, investigators reported that the SGLT2 inhibitor dapagliflozin did not benefit patients with COVID-19 who had cardiometabolic risk factors.

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Bayer looks to expand Kerendia label to include heart failure

Pharmaceutical Technology

Bayer adds three new Phase III heart failure studies to the Kidney and type 2 diabetes drug, Kerendia, clinical development programme.

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HDA 2023 Traceability Seminar: DSCSA Areas of Improvement

Pharmaceutical Commerce

Session offers information on industry readiness, plus an overview of a phase implementation recommendation.

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Twist and Ono partner to develop antibodies for autoimmune diseases

Pharmaceutical Technology

Twist and Ono will discover and develop novel antibodies to treat autoimmune diseases and generate comprehensive discovery campaigns.

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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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Study: COVID-19 Pandemic Associated With Worse Treatment, Outcomes in Patients With Acute Myocardial Infarction

Pharmacy Times

Although the pandemic has negatively influenced the care that patients with cardiovascular conditions receive, the study authors found that there were not significant inequities regarding patients’ race.

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NexImmune to lay off over half of its employees

Pharmaceutical Technology

NexImmune will reduce its workforce from 47 to just 22 full-time employees and has also paused enrolment for three of its trials.

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AmerisourceBergen Changes Name to Cencora

PharmExec

Shift comes with $5 million dedication to launch Cencora’s healthier futures grant program.

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The benefits of using an app to manage gestational diabetes: Niki’s story

Pharmaceutical Technology

When expectant mothers are diagnosed with gestational diabetes mellitus (GDM) they often feel anxious and need extra support.

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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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Monthly Employee Portal Updates | August 2023

Progressive Medical

You must be a registered user to view this information. The post Monthly Employee Portal Updates | August 2023 appeared first on Progressive Medical, Inc.

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Sage Therapeutics fires 40% of staff after FDA rejected MDD bid

Pharmaceutical Technology

The company announced a strategic shake-up that includes layoffs, leadership changes and halting of early-stage programs.

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Presymptomatic Atherosclerosis May Contribute to the Development of Alzheimer Disease Later in Life

Pharmacy Times

Heart health may influence long-term brain health as early as middle age.

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Huadong enters licence deal for MC2 Therapeutics’ Wynzora cream

Pharmaceutical Technology

Huadong has entered into an agreement to acquire licence rights for MC2 Therapeutics’ Wynzora cream in Greater China.

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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.