Fri.Sep 15, 2023

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J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

Marketing 307
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Most Hospitals Are Still Violating HIPAA By Using Web Tracking Tools, Despite Federal Warnings

MedCity News

The federal government has warned hospitals that using third-party analytics tools on their websites could violate HIPAA, and more than 20 hospitals are facing class-action lawsuits over the use of these tools. But a recent analysis found that hospitals are doing a poor job of fixing their websites and preventing patient data collection.

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Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Fierce Pharma

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophreni | Lyndra Therapeutics is laying off staff two months after a CEO swap and as interim data from a pivotal trial for a schizophrenia drug nears. The company's lead asset is a long-acting, oral version of Johnson & Johnson's Uzedy.

Leads 290
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Small molecule drug shows promise in rare disease

European Pharmaceutical Review

The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance. Dercum’s disease is characterised by painful lipomas developing primarily on the trunk in the body. Currently there are no approved or effective medicine, so the data from the Phase II study shows potential of a treatment for this indication.

Safety 117
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Bayer CEO plots management cuts as first step in larger overhaul: Reuters

Fierce Pharma

Just a few months into Bill Anderson's tenure as Bayer's CEO, the helmsman is reportedly looking to trim the drugmaker's management ranks. | The CEO is eying some big changes, but he wants to show investors he's prepared to act swiftly, Reuters reports. The publication cited three people "familiar with the matter" in reporting the behind-the-scenes developments at Bayer.

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Civil Rights Groups File Complaint Against Florida for Medicaid Redeterminations Process

MedCity News

More than a dozen civil rights organizations alleged in a new complaint that Florida uses administrative practices that are preventing underserved communities from renewing their Medicaid coverage.

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Meaningful Hospital Price Transparency Requires Actual Prices, Not Estimates

MedCity News

Only actual hospital prices, displayed as dollars and cents, not estimates, formulas, or algorithms, protect patients from outrageous bills and hold hospitals accountable for overcharges, errors, and fraud. Accepting CMS’ or other substitutes instead of actual prices undermines broader efforts to make hospital price transparency a reality for American patients and healthcare consumers.

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Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

Fierce Pharma

With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of weighty patent losses.

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RayzeBio, Neumora Perk Up the IPO Market, Raising $561M for Clinical Trials

MedCity News

RayzeBio’s IPO will support pivotal testing of a targeted radiopharmaceutical for cancer patients who progress after treatment with Novartis’s Lutathera. Neumora will apply its IPO cash toward Phase 3 testing of a depression drug with a novel mechanism of action.

Marketing 104
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Janssen rebrands its identity

European Pharmaceutical Review

The Janssen Pharmaceutical Companies of Johnson & Johnson has changed its name to Johnson & Johnson Innovative Medicine (J&J Innovative Medicine). Johnson & Johnson is bringing together its divisions under the J&J brand name. While Janssen, J&J’s pharmaceutical division will be known as J&J Innovative Medicine, the company’s medical technology segment will continue to be named Johnson & Johnson MedTech.

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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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SparingVision shares trial updates for rare eye disease gene therapies

Pharmaceutical Technology

The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.

Leads 105
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Astellas to invest over €330m in a new facility in Ireland

PharmaTimes

The site will contribute to the development and commercialisation of antibody drugs - News - PharmaTimes

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Cure Genetics and Frametact seek gene cures for neurological ailments

Pharmaceutical Technology

Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.

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MIT’s new technique to remotely evaluate cerebral palsy patients

PharmaTimes

The method could also be beneficial for Parkinson’s disease and strokes - News - PharmaTimes

Patients 107
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pelican Appoints New CEO

Pharmaceutical Commerce

Protective case manufacturer hires James Curleigh, as company prepares to further innovation and expand.

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Authors Target OpenAI, Meta With More Suits

Copyright Clearance Center

The post Authors Target OpenAI, Meta With More Suits appeared first on Copyright Clearance Center.

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NICE recommends Idorsia’s chronic insomnia treatment for UK patients

Pharmaceutical Technology

The therapy will be available to patients who have insomnia multiple times a week, do not respond to CBTi, and whose wakeful day is severely impacted.

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Audio Success in Pharma

PharmExec

Panel at recent Talk Health event at Le Méridien, in Philadelphia, PA, on September 11th, 2023, focused on what success looks like in audio from a publisher, vendor, and HCP perspectives.

Pharma 52
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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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Creating Powerful Patient Testimonial Videos

LEVO Health

Patient testimonials have always been a cornerstone of trust in the healthcare industry. In our digital age, these testimonials have evolved from written reviews to dynamic video content. Patient testimonial videos not only humanize the healthcare experience but also provide potential patients with relatable stories that can influence their healthcare decisions.

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Apollo Therapeutics Closes $226.5 Million Series C Financing

PharmaTech

It was noted that there was participation by multiple new investors including M&G plc, in addition to two of the largest US public pension plans and the existing investor, Rock Springs Capital. Further, the financing significantly adds to the $195 million previously raised by the company, according to the press release.

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No more cookies: How healthcare companies can gain trust for data consent

Pharmaceutical Technology

Healthcare and life sciences companies have long relied on third-party cookies for their digital marketing. As browsers now start to block these data-tracking tools, we explore how companies can deliver personalised digital experiences by using a transparent digital approach.

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The IRA Effect: How the Inflation Reduction Act Will Reshape Behaviors in Biopharma

Zymewire

The IRA: What is it? Signed into law in August 2022, the Inflation Reduction Act (IRA) was designed to fight inflation, invest in domestic (US) energy production & manufacturing, and reduce carbon emissions. The bill also enables Medicare to negotiate prescription drug prices and extends the Affordable Care Act through 2025.

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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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Janssen Submits Marketing Authorization Application to EMA For Approval of Erdafitinib

PharmaTech

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Safety 52
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Congress is Expected to Bring PBM Transparency Legislation

Pharmaceutical Commerce

PBM transparency and data reporting requirements are likely to be part of a larger healthcare bill that Congress will work on this fall.

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Charles River and Related Sciences partner for AI drug platform

Pharmaceutical Technology

Charles River has signed a multi-programme collaboration agreement with Related Sciences (RS) for the AI-powered drug platform, Logica.

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Clinical Overview: Fecal Microbiota Transplantation vs Live Biotherapeutic Products for Management of Recurrent C Difficile Infection

Pharmacy Times

Although antibiotics are the standard-of-care treatment for Clostridioides difficile infection, they can cause further microbiota changes that predispose patients to recurrence.

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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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EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

Pharmaceutical Technology

The EMA CHMP has recommended granting marketing authorisation for Moderna’s updated Covid-19 vaccine targetting XBB.1.5 sublineage.

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Expert: Artificial Intelligence Changing the Field of Medical Writing

Pharmacy Times

The CEO of Yseop discusses how AI can have a positive impact in the development of high quality medical writing due to its efficiency and ability to reduce long, tedious tasks for writers.

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Remote Patient Monitoring market will reach $760m by 2030

Pharmaceutical Technology

A new report found that the Remote Patient Monitoring (RPM) sector will grow, since the pandemic revealed the benefits of remote healthcare.

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Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations

Pharmacy Times

Community pharmacies and organizations can collaborate to tailor strategies and interventions and address the challenges and specific needs of the community.

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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.