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 291
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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 109
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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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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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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 257
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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.

Patients 106

More Trending

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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.

Patients 102
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After FDA setback, PTC Therapeutics' DMD drug Translarna faces possible market withdrawal in Europe

Fierce Pharma

A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review. | A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review.

FDA 222
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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.

Patients 100
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CPHI Pharma Awards 2023 finalists announced

European Pharmaceutical Review

For its 20 th anniversary, more than 180 entries across 12 categories have been narrowed down to determine the finalists the upcoming CPHI Pharma Awards. To recognise the influx of innovation across the pharmaceutical industry, three new categories are included in this year’s awards. The shortlisted finalists of the CPHI awards for 2023 include companies that led by example in sustainable manufacturing, manufacturers and innovators that developed new technologies to advance drug discovery, devel

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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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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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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Pelican Appoints New CEO

Pharmaceutical Commerce

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

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

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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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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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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

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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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ABM Success Recipe: Mastering the Crawl, Walk, Run Approach

Shifting to an account-based marketing (ABM) strategy can be both exciting and challenging. Well-implemented ABM motions build engagement with high-value accounts and drive impactful campaigns that resonate with your audience. But where do you begin, and how do you progress from crawling to running? Watch now as Demand Gen experts delve into the essentials of each stage of the ABM process.

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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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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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How Intent Data Helps Marketers Convert A-List Accounts

One of the biggest challenges for any B2B marketer is understanding your prospects’ next move — who is most likely to buy and when. Without these insights, marketing campaigns can feel more like guesswork, with high investment and little return. We’re here to tell you there’s a better way. By tracking buyers’ digital footprints and online activity, such as website visits, product reviews, and spikes in content consumption, you can engage prospects with a message that really resonates.

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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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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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Solving the Biggest Tech Challenges in RevOps

In this eBook, we’ll run through real-world examples that show how RevOps teams can benefit from modern solutions for the access, management, and activation of their GTM data. Whether you need to improve lead response times, boost adoption of core tools, improve lead qualification, or target and automate your GTM motions, you’ll find examples of how revenue teams are solving some of the toughest problems in modern business.

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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.

Medical 60
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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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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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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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Drive GTM Efficiency with Tech Stack Consolidation

Consolidating your tech stack is an effective cost-saving measure that drives GTM efficiency and adds value to your enterprise. With a cohesive, integrated tech stack, your revenue teams can deliver an excellent customer experience that sets you up to win faster than your competitors.