Sat.Apr 13, 2024 - Fri.Apr 19, 2024

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What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

MedCity News

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Personalization In Sales Leads To Increased Loyalty and Repeat Business

Integrity Solutions

Mastering the human side of selling is key to sales success, but what does phrase that mean exactly? At its essence, humanizing the sales experience is really about personalization. It’s about asking questions from a place of genuine curiosity, listening, fully absorbing what you’re hearing and then being willing and able to pivot in whatever direction the customer’s answers take us.

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In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity

MedCity News

Achieving strong cybersecurity is a vast, interconnected web that must incorporate the correct software, procedures, and workflows and take into account the human element across an entire organization. The post In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity appeared first on MedCity News.

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Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Fierce Pharma

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

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LogiPharma Europe 2024: Niklas Adamsson Discusses Ways to Improve Visibility and Risk Management for Cold Chain Shipping

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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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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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

MedCity News

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.

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Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use

Fierce Pharma

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

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Regeneron launches $500m venture capital arm

pharmaphorum

Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.

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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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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Confronting the Digital Dilemma in Healthcare’s Quest for Innovation

MedCity News

The imperative to modernize healthcare communication methods extends beyond mere technological upgrades. Rather, it’s a fundamental necessity to enhance patient care, streamline healthcare delivery, and unlock the full potential of medical innovation. The post Confronting the Digital Dilemma in Healthcare’s Quest for Innovation appeared first on MedCity News.

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Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

Fierce Pharma

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug

PharmaVoice

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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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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Inflammation among current dementia research focus, says Alchemab CSO

Pharmaceutical Technology

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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Novel Parkinson’s Disease Drug Will Join AbbVie With Positive Phase 3 Data In Hand

MedCity News

Cerevel Therapeutics drug tavapadon met the main and secondary goals of a pivotal Parkinson’s disease clinical trial. That drug and others will join the neuroscience portfolio of AbbVie, which is in the process of acquiring Cerevel. The post Novel Parkinson’s Disease Drug Will Join AbbVie With Positive Phase 3 Data In Hand appeared first on MedCity News.

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Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group

Fierce Pharma

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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Levo Health Sponsors Tampa Bay Wave’s HealthTech|X Accelerator Program

LEVO Health

At Levo Health, we’re always on the lookout for opportunities to push the boundaries of healthcare marketing and support innovations that can transform the industry. This year, we’re thrilled to take our commitment a step further by sponsoring the 2024 HealthTech|X Accelerator program hosted by Tampa Bay Wave. Tampa Bay Wave has a proven track record of fostering startup success, having supported 527 startups, collectively raising over $900 million in capital and creating more than 5

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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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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment

European Pharmaceutical Review

New trial results for GSK’s oral gepotidacin, a potential first-in-class oral antibiotic, has shown that it was non-inferior with 92.6 percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide” In the pivotal EAGLE-1 Phase III trial, comparatively, intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a

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Hospital M&A Activity in 2024: What to Expect

MedCity News

Q1 2024 saw a significant rise in the number of hospital M&A deals compared to the past three Q1s. Experts believe this M&A activity will continue to climb throughout this year and next — motivated by both financial distress and hospitals’ desire to improve strategic business lines like value-based care and digital healthcare services. The post Hospital M&A Activity in 2024: What to Expect appeared first on MedCity News.

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With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Fierce Pharma

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

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At Princeton University Press, The Mission is “Our Compass”

Copyright Clearance Center

In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.

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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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Heart disease risk ‘calculator’ could save lives

pharmaphorum

UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.

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Included Health Announces New Specialty Care Offering

MedCity News

Included Health’s new specialty care clinic, which will become available in 2025, is starting by offering three centers: the Cancer Center, the Center for Women’s Health and the Center for Metabolic Health. The post Included Health Announces New Specialty Care Offering appeared first on MedCity News.

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Amgen CEO nabs pay raise thanks to Horizon deal. Does that incentivize aggressive M&A?

Fierce Pharma

Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company’s acquisition of Horizon Therapeutics. | Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company's acquisition of Horizon Therapeutics.

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A Work in Progress: CCC and Artificial Intelligence

Copyright Clearance Center

In a recent town hall webinar, The Heart of the Matter: Copy­right, AI Training and LLMs, CCC (Copyright Clearance Center) made the case that current artificial intelligence (AI) technology infringes copyrights, both in the way its underlying large language models (LLMs) are developed, or trained, and in the outputs it enables users to create.

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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.