Tue.Dec 05, 2023

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As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

Fierce Pharma

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs.

Sales 274
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Moving Beyond Medicine To Treat Chronic Pain

MedCity News

I look at non-pharmacological approaches like digital therapeutics as having the potential to give someone like me living with chronic pain everything I need to make a healthy recovery: access to digital treatments and clinicians, to community, coaching, and navigation services.

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Travere cuts workforce by 20% as Filspari's prospects are up in one rare kidney disease, down in another

Fierce Pharma

Travere Therapeutics will reduce its workforce by 20%, with the jo | Travere Therapeutics will reduce its workforce by 20%, with the job cuts focused on “non-field-based employees,” the company said on Tuesday. The layoffs are part of a shake-up of the San Diego-based company as it focuses on its launch of kidney drug Filspari and develops pegtibatinase as a potential treatment for the metabolic disorder homocystinuria (HCU).

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FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC

PharmExec

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

FDA 116
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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In letter to lawmakers, cancer patient advocates call for more action in fighting drug shortages

Fierce Pharma

As the year comes to a close, shortages of key cancer drugs have no end in sight. | In its letter to congressional leaders, the American Cancer Society Cancer Action Network (ACS CAN) outlined the root causes of drug shortages and offered potential solutions. Further, the group detailed the impact of the crisis on both adult and child cancer patients.

Patients 214
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After Data Miss in Lead Cancer Indication, Replimune Maps Path for Oncolytic Virus

MedCity News

Replimune’s lead therapeutic candidate did not meet the two main goals of a study intended to support an FDA submission in cutaneous squamous cell carcinoma. But Replimune’s therapy, an oncolytic virus, has better data in melanoma, and the company plans a 2024 FDA submission in this skin cancer.

Leads 111

More Trending

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Expert: The Killer App of AI in Radiology Is Anything that Boosts Workflow Integration

MedCity News

The AI tools that radiologists need the most are ones that integrate their workflows and make it easier to access past images, said Dr. Jocelyn Chertoff, radiology chair at Dartmouth Health. When adopting AI to address their workforce shortage, hospitals need to involve clinicians early-on in decisions about what new tools to implement, she also noted.

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Pharma group blasts UK's drug rebate scheme shortly after lauding 'landmark' spending deal

Fierce Pharma

Despite what was presented as a “landmark” deal between the pharmaceutical companies and the government, the U.K.’s pharma association has not stopped pressuring the government for more industry-fr | Despite what was presented as a “landmark” deal between the pharmaceutical companies and the government, the U.K.’s pharma association has not stopped pressuring the government for more industry-friendly spending policies.

Pharma 143
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Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance

MedCity News

Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.

Medical 111
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Phase III data for novel telomerase inhibitor released

European Pharmaceutical Review

Results from Geron’s Phase III IMerge trial evaluating its first-in-class investigational telomerase inhibitor imetelstat, have shown long-term and durable response in participants with a rare haematologic malignancy. Efficacy of the treatment was compared to placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

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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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How the Patient Perspective Can Drive Powerful Clinical Study Designs in Oncology

MedCity News

Regulators and experts consider patient-reported outcomes (PROs) as the gold standard when assessing a patient’s subjective treatment experience. As such, ePROs can be the key to product differentiation for sponsors seeking to highlight their product’s ease of administration, tolerability, or compatibility in combination with other components of a treatment regimen.

Patients 104
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UK’s entrance into Horizon Europe finalised

European Pharmaceutical Review

With the UK set to become an associated country to Horizon Europe on 1 January 2024, the political agreement on UK’s association to Horizon Europe has been adopted. Now, this final step in the process has been implemented by the EU-UK Specialised Committee on Participation in Union Programmes (SCPUP), the European Commission (EC) has announced. The programme is the EU’s key funding initiative for research and innovation with a budget of €95.5 billion for 2021-27.

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Amicus Leader, BIO Board Member John Crowley Named Trade Group’s New CEO

MedCity News

BIO’s new president and CEO is a familiar face. John Crowley, a longtime BIO board member, was named the life sciences industry trade group’s new leader, starting in March.

Biopharma 102
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Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

Marketing 111
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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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Hims & Hers Gets Into Weight Loss Treatment

MedCity News

Hims & Hers unveiled a new weight loss program on Monday that includes access to medications, educational content and digital tracking tools.

Education 109
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Roche to advance novel obesity and diabetes treatments

European Pharmaceutical Review

Roche has agreed to acquire biotech Carmot Therapeutics for an upfront purchase price of $2.7 billion, enabling the Swiss pharma company to add a range of incretin treatments for obesity and diabetes to its portfolio. Incretins are “gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion and suppressing appetite,” Roche highlighted.

Food 94
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Oxford Biomedica agrees to acquire ABL Europe

Pharmaceutical Technology

Oxford Biomedica has signed an agreement to acquire CDMO ABL Europe from Institut Mérieux subsidiary TSGH SAS in a deal worth €15m ($16.27m).

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KCL molecular communication system to revolutionise drug delivery

PharmaTimes

The platform safely and effectively replicates the electric signalling process compounds - News - PharmaTimes

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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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Pharma accuses UK of ‘mixed messages’ on rebate schemes

pharmaphorum

The pharma industry and the UK government may have reached an accord on the voluntary scheme of rebates used to limit rises in medicines spending in the UK, but the alternative statutory scheme remains a prickly subject.

Pharma 78
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NIHR invests £55m to tackle health inequalities and outcomes

PharmaTimes

Millions of people in the UK are set to benefit from the second wave of funding - News - PharmaTimes

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A Day In The Life Of A Cardiac Rhythm Clinical Specialist With Crystal Sobande

Evolve Your Success

Being present is not just a strategy; it’s the heartbeat of professional evolution. In this episode, Crystal Sobande , Cardiac Rhythm Clinical Specialist, openly discusses her transition from selling cosmetic dermatology treatments to navigating the ever-changing world of medical devices. Discover the behind-the-scenes hustle and unpredictability as Crystal walks us through the typical day in her life.

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Eli Lilly Announces Availability of Obesity Drug Zepbound at US Pharmacies

PharmExec

Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths.

Retail 64
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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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BMS chases MSD/Seagen with first-line bladder cancer filing

pharmaphorum

BMS chases MSD/Seagen with first-line bladder cancer filing Phil.

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Opdivo Combination Granted FDA Priority Review for Unresectable, Metastatic Urothelial Carcinoma

Pharmaceutical Commerce

Opdivo (nivolumab) plus cisplatin-based chemotherapy shows improved survival benefits in the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

FDA 52
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Changes to hospital price transparency requirements address data availability and quality

Clarify Health

Since January 2021, U.S. hospitals must share clear, accessible information online about the standard charges for the services provided to improve healthcare price transparency. Unfortunately, however, compliance with CMS regulations has been lacking. As of last summer, and more than two and a half years after the enforcement date, only about a third of hospitals fully complied with hospital price transparency requirements.

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AI is Here – Considerations for How Your Brand’s Patient Support Services Will Be Impacted

Pharmaceutical Commerce

AI is here – are you ready? In today’s podcast we talk with Ron Lacy, Vice President of Product and Innovation from UBC about how AI is changing the services in the patient services market. We will discuss with Ron how the use of cognitive services including large language models are changing how patient support services interact with their stakeholders including patients, payers, and even prescribers while still providing exceptional support for benefit verifications, reducing time to complete

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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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Q&A: How Does a ‘Never Enough’ Achievement Culture Impact Your Workforce’s Morale? Planning for 2024 With Journalist and Author Jennifer Breheny Wallace

PharmExec

Jennifer Breheny Wallace, award-winning journalist and author, notes that C-Suite leaders should understand the financial risks of not taking action to address workplace burnout in 2024.

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Obesity Treatment Zepbound Now Available in United States

Pharmaceutical Commerce

Eli Lilly and Company's obesity drug Zepbound (tirzepatide) has a list price of $1,059.87, which is approximately 20% less than the 2.4 mg semaglutide injection indicated for weight loss.

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5 Predictions: The Impact of Generative AI on Sales in 2024

Quantified

If your business has been around long enough, you likely remember the days of sales in the field, knocking on doors and pounding pavement to drum up leads. Over the years, however, there have been innovations and transformations in how your sales teams cold call, nurture, present to, and close new customers. You’re not pounding pavement anymore.

Sales 52
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Investigational Treatment for High-Risk Bladder Cancer Awarded FDA Breakthrough Designation

Pharmaceutical Commerce

Johnson & Johnson’s TAR-200 has a novel targeted releasing system that allows for a controlled release of gemcitabine in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

FDA 52
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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.