Fri.Jun 07, 2024

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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SCOTUS Deals a Blow to Medical Debt Collectors

MedCity News

The Consumer Financial Protection Bureau, which has been targeting debt collection practices, survives a Supreme Court challenge. The post SCOTUS Deals a Blow to Medical Debt Collectors appeared first on MedCity News.

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Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm

Fierce Pharma

After fessing up to wire fraud charges, a former Takeda employee will be preparing for a sentencing hearing rather than walking down the aisle with $2.3 million garnered through a scheme to defraud | Priya Bhambi, 40, pled guilty to wire fraud charges after running a detailed scheme to scam Takeda into paying for non-existent services from a fake consulting firm.

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Preventative Care: The Right Approach to Improving Endpoint Security

MedCity News

While firewalls, network monitoring and other security practices are imperative, it pays to give more thought to how to better secure endpoint computing. The post Preventative Care: The Right Approach to Improving Endpoint Security appeared first on MedCity News.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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With 2 planned launches, Boehringer Ingelheim looks to make a name for itself in oncology

Fierce Pharma

With 25 launches planned through 2030, Boehringer Ingelheim is gearing up for a busy few years. | The company expects to introduce brigimadlin in dedifferentiated liposarcoma and zongertinib in HER2-mutated non-small cell lung cancer next year. The launches are part of the company's wider plan to bring 25 new products to the market by 2030.

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Zeto Receives FDA Clearance for Its User-Friendly EEG Brain Monitoring System

MedCity News

Medical device company Zeto received clearance for its EEG brain monitoring system. The system includes a user-friendly, comfortable EEG headset designed to be easily operated by any medical professional with minimal training. The post Zeto Receives FDA Clearance for Its User-Friendly EEG Brain Monitoring System appeared first on MedCity News.

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Healthcare Errors: It Is Time to Tackle Them, Not Tolerate Them

MedCity News

We call for our partners in practice, education, and industry to join this effort to make our healthcare settings safer for all patients. The post Healthcare Errors: It Is Time to Tackle Them, Not Tolerate Them appeared first on MedCity News.

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Nestle bids to take control of Seres’ C diff drug Vowst

pharmaphorum

Nestle Health Science bids to take control of Seres Therapeutics’ oral microbiome product Vowst for preventing C. diff infections.

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Rapport’s Stock Market Debut Reaps $154M as Novel Epilepsy Med Heads for Mid-Stage Test

MedCity News

Rapport Therapeutics’ IPO came with a concurrent private placement that boosted the biotech’s cash haul. The new capital will support clinical development of a lead drug with a novel approach to focal epilepsy, a form of the disorder that affects 1.8 million people in the U.S. The post Rapport’s Stock Market Debut Reaps $154M as Novel Epilepsy Med Heads for Mid-Stage Test appeared first on MedCity News.

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Cycle Pharma makes $466m takeover bid for Vanda

pharmaphorum

UK group Cycle Pharma has made an unsolicited takeover bid to buy Vanda Pharma, which is already fending off an overture from Future Pak.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Applying Non-health Payment Experiences to Healthcare

MedCity News

When it comes to consumer – and patient – preferences for payment options, security and speed reign supreme. The post Applying Non-health Payment Experiences to Healthcare appeared first on MedCity News.

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Regulation and legislation in the era of automation and digitalisation

European Pharmaceutical Review

Friend or foe? Pharmaceutical companies ask themselves this question before embracing the latest technologies because every innovation comes with both opportunities and risks. Today, technological advancements in artificial intelligence (AI), machine learning (ML), digitalisation, and robotic manufacturing automation solutions stand to revolutionise R&D, clinical trials, and manufacturing in the pharmaceutical industry.

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Boehringer Ingelheim’s survodutide shows promise in liver fibrosis treatment

PharmaTimes

Phase 2 trial reveals significant improvement in MASH patients

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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Scott Burrows: Empowering Financial Advisors with Vision and Resilience

Scott Burrows

In my journey as a keynote motivational speaker within the financial services industry, I’ve had the privilege of addressing esteemed organizations such as Merrill Lynch, Janney Montgomery, Morgan Stanley, Met Life, Farmers and Edward Jones, among others. Through these engagements, I’ve shared my life-transforming story and principles of success anchored in Vision, Mindset, and Grit.

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First-in-class telomerase inhibitor approved for blood cancer

European Pharmaceutical Review

The first telomerase inhibitor has been approved by the US Food and Drug Administration (FDA). RYTELO ( imetelstat ) is authorised for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia. The first-in-class oligonucleotide telomerase inhibitor is indicated for these patients who need four or more red blood cell units over eight weeks, who are unresponsive to or ineligible for erythropoiesis-stimulating agents (ESA).

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Report: Virtual MSK Solutions Meaningfully Improve Outcomes

MedCity News

The Peterson Health Technology Institute recently released a report that evaluated eight musculoskeletal solutions: DarioHealth, Hinge Health, Kaia Health, Limber Health, Omada Health, RecoveryOne, Sword Health and Vori Health. The post Report: Virtual MSK Solutions Meaningfully Improve Outcomes appeared first on MedCity News.

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Serac’s imaging agent marks a breakthrough in endometriosis detection

PharmaTimes

Early-stage endometriosis now visible through non-invasive imaging

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

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Geron finally brings a drug to market as FDA clears Rytelo

pharmaphorum

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo. The US regulator has cleared Rytelo (imetelstat) for adults with lower-risk MDS who have transfusion-dependent anaemia and have stopped responding to or cannot be treated with erythropoiesis-stimulating agents (ESAs) like erythropoietin (EPO).

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Combining RWE and AI to Bend the Adherence Curve

Pharmaceutical Commerce

By marrying real-world evidence and AI, pharma stakeholders can identify new opportunities to tailor interventions in a way that is most impactful to patients—helping them overcome roadblocks in initiating and maintaining therapy.

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FDA admonishes Jiangsu Hengrui’s manufacturing site following inspection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

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Trends and Obstacles in the CGT Field (BIO 2024)

PharmaTech

Lonza’s Joe Garrity and Jerry Jiang discuss the latest trends and challenges in commercializing new CGTs.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Janssen RSV Protein Vaccine Displays Long-Term Efficacy Among Older Adults

Pharmacy Times

A single dose of the vaccine showed long-lasting protection against RSV-associated lower respiratory tract disease in older adults.

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The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

PharmaTech

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

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FDA AdCom to question efficacy and safety concerns with Eli Lilly’s Alzheimer’s drug

Pharmaceutical Technology

The FDA is looking to ask questions about a change of primary endpoint, treatment cessation and mortality reporting from the donanemab trial.

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Pharma Pulse 6/7/24: Mark Cuban Talks Drug Pricing, Cost Remains Barrier to Respiratory Care for Patients & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ASCO24: Another win for Opdivo/Yervoy in first-line HCC despite uncertainties

Pharmaceutical Technology

The prognostic factor(s) driving outcomes at the initial stages of hepatocellular carcinoma remain unclear, complicating the treatment choice.

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Cencora VP & Head of Cell & Gene Therapy Service Line Discusses Industry Pain Points and Technological Capabilities

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Lung-I Cheng, PhD, VP, Head of Cell & Gene Therapy Service Line, Cencora, offers his thoughts on industry pain points and where he envisions the market progressing in terms of its technological capabilities.

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Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset

Pharmaceutical Technology

Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for IPF treatment AGMB-447.

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Public Sentiments Toward Purchasing Foreign Vaccines During a Pandemic

Pharmaceutical Commerce

Causal mediation analysis sought to determine how public hesitancy plays a role in the government procurement of certain vaccines.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A