Fri.Jun 07, 2024

article thumbnail

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.

FDA 339
article thumbnail

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.

Medical 111
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

article thumbnail

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

Medicine 106
article thumbnail

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

article thumbnail

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.

Marketing 243
article thumbnail

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.

More Trending

article thumbnail

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.

FDA 106
article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

Pharma 100
article thumbnail

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.

article thumbnail

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.

article thumbnail

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).

article thumbnail

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.

article thumbnail

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.

90
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

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.

article thumbnail

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).

FDA 77
article thumbnail

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.

article thumbnail

Boehringer Ingelheim’s survodutide shows promise in liver fibrosis treatment

PharmaTimes

Phase 2 trial reveals significant improvement in MASH patients

Patients 100
article thumbnail

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.

article thumbnail

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.

Pharma 59
article thumbnail

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.

article thumbnail

Serac’s imaging agent marks a breakthrough in endometriosis detection

PharmaTimes

Early-stage endometriosis now visible through non-invasive imaging

87
article thumbnail

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.

Pharma 52
article thumbnail

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

article thumbnail

How ChatGPT Enterprise Changed Moderna's Use

PharmExec

In this part of his Pharmaceutical Executive video interview, Brice Challamel, Vice President, AI Products & Platforms, Moderna, discusses their internal AI chatbot tool, mChat, and how the launch of ChatGPT Enterprise changed things.

article thumbnail

Drug Digest: Changes and Trends in the Outsourcing Landscape

PharmaTech

In this episode of Drug Digest, industry experts discuss the current outsourcing landscape in the post-COVID world and the changes the pandemic has enforced in the demand for outsourced bioprocessing services.

52
article thumbnail

Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor

PharmExec

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

article thumbnail

Curevac gets grant for pharmaceutical composition for rsv vaccine with modified fusion protein

Pharmaceutical Technology

Discover Curevac NV's groundbreaking patent for an mRNA-based RSV vaccine, targeting prophylaxis and treatment. Learn about the innovative pharmaceutical composition and method for stimulating a robust immune response against RSV.

article thumbnail

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

article thumbnail

FDA Approves Geron Corporation’s Rytelo to Treat Adults with Lower-Risk Myelodysplastic Syndromes

PharmExec

Approval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.

FDA 52
article thumbnail

Botanix Pharmaceuticals gets grant for topical treatment for dermatitis with cannabidiol in specific composition

Pharmaceutical Technology

Discover Botanix Pharmaceuticals' patented treatment regime using cannabidiol for dermatitis and skin conditions. Administering between 50-3000 mg daily, this topical solution offers a unique approach to skincare.

article thumbnail

Medical Sales Targeting (Part 1)

Cesare Ferrari

Reaching the right doctor with the right product, and the right message, at the right time is the essence of targeting and medical marketing in general. If you are a medical sales rep working for a pharma or a medical device company, you might already have experienced the frustration of not convincing a prospect about your product. Even very successful products with high use and market penetration are not for everybody in a given market.

article thumbnail

Syndax Pharmaceuticals gets grant for inhibitors of menin-mll interaction for cancer treatment

Pharmaceutical Technology

Discover the groundbreaking patent by Syndax Pharmaceuticals Inc for compounds targeting menin-MLL interaction in leukemia treatment. Learn more about this innovative approach to fighting cancer.

article thumbnail

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.