Tue.Jan 23, 2024

article thumbnail

J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm

Fierce Pharma

Early evidence showing Carvykti’s potential to prolong patients’ lives in an earlier multiple myeloma setting didn’t save Johnson & Johnson and Legend Biotech’s CAR-T medicine from a public int | Early evidence showing the drug's potential to prolong patients' lives didn't save Johnson & Johnson and Legend Biotech's Carvykti from a public interrogation by the FDA.

FDA 206
article thumbnail

Return-to-Office Pushes Can Cause a ‘Riot’

Copyright Clearance Center

A growing number of managers want workers in the office more often, citing the connections, collaborations, and innovations that in-person work can bring.

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

Genmab loses appeal in Darzalex royalties arbitration case against Johnson & Johnson

Fierce Pharma

While sales for Johnson & Johnson’s Darzalex continue to boom—as the company reported in its quarterly earnings presentation on Tuesday—the pharma major got more good news about its blockbuster | An appeal arbitrator has rejected Genmab’s claim that it is due additional milestone and royalty payments from Johnson & Johnson for Darzalex. The Danish biotech was hoping to overturn a 2-1 ruling in a second arbitration between the companies over Darzalex royalties.

Pharma 203
article thumbnail

Sanofi Commits $1.7B to Buy an Entire Company, But Wants Just a Single Drug

MedCity News

Sanofi is acquiring Inhibrx to get its hands on a drug candidate in pivotal testing for the protein deficiency alpha-1 antitrypsin deficiency, which leads to lung and liver problems. Inhibrx’s remaining assets will be spun out into a new company.

Leads 110
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Johnson & Johnson inks $700M deal to resolve talc consumer protection claims from 42 states

Fierce Pharma

After failing to resolve a mountain of talcum-powder lawsuits through two unsuccessful bankruptcy attempts, Johnson & Johnson has agreed to a $700 million settlement that would free the company | After failing to resolve a mountain of talcum-powder lawsuits through two unsuccessful bankruptcy attempts, Johnson & Johnson has agreed to a $700 million settlement that would free the company from some consumer protection claims—and a small part of the talc litigation that it faces.

203
203
article thumbnail

Lightfully Behavioral Health Launches Virtual Offering for College Students

MedCity News

Lightfully Behavioral Health unveiled Lightfully U last week. The virtual intensive outpatient program is specifically designed for college students and offers primary and family therapy, access to a psychiatrist, group sessions and other support.

107
107

More Trending

article thumbnail

What’s Next for Clinical Decision Support Tools?

MedCity News

Technology evolved over these five decades to respond to the needs of users. Based on my experience and interactions with other leaders in the market, here are three technology trends I expect in 2024.

article thumbnail

Is AI’s Copyright World Flat, or Will AI Flatten the Copyright World?

Copyright Clearance Center

AI is global, and copyright laws are national. Thus, some countries will have strict laws on making copies of copyrighted content to “train” an AI system while others will be more relaxed. AI companies will use these jurisdictional differences as leverage to lobby for the relaxation of legal standards.

article thumbnail

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety 97
article thumbnail

Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs

Pharmaceutical Commerce

Study describes how a game theoretic model can successfully analyze how adoption of blockchain technology can reveal quality information.

110
110
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

Will new therapeutic agent replace antibodies for bacterial detection?

European Pharmaceutical Review

As a tool for detecting and identifying bacteria, aptamers are a promising new class of synthetic nucleic acid molecules that can be used to detect and treat of pathogenic bacteria. With the ability to be developed against a whole bacterium, a microbial toxin, or some proteins, for some bacteria, “aptamers against pathogens can not only supplement the deficiency of antibodies but can also enrich the aptamer database to develop efficient analytical regents”, according to a paper published in the

article thumbnail

The Weight Loss Market in 2024: 3 Key Questions We Can No Longer Ignore

MedCity News

In 2024, the weight loss market finds itself at a crossroads, grappling with pivotal questions that will shape the future. The winners will prioritize affordable lifelong care, scalable coaching and support, and a diverse set of solutions that give people second and third chances along their weight loss journeys.

article thumbnail

UK MHRA strengthens regulations on fluoroquinolone antibiotics

Pharmaceutical Technology

The UK MHRA has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.

98
article thumbnail

Turquoise Health Raises $30M for its Price Transparency Software

MedCity News

Turquoise Health closed a $30 million Series B round, which brings its total funding to date to $55 million. The San Diego-based startup, which has more than 160 customers, sells a platform that makes it easier for hospitals and payers to comply with price transparency regulations.

85
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

NICE backs two AIs for stroke diagnosis in NHS

pharmaphorum

Two artificial intelligence-powered software tools – e-Stroke and RapidAI – have been recommended for use in the NHS to help detect stroke from CT brain scans by NICE. The health technology assessment (HTA) agency said there is some evidence that people admitted to hospital with a suspected had faster or better access to treatment after using the software, although for now it is unclear whether that was a direct consequence of the digital technology.

81
article thumbnail

Genentech signs nanoparticle deal worth up to $644m with GenEdit

Pharmaceutical Technology

Genentech will utilise GenEdit’s non-viral polymer nanoparticles for gene therapy delivery in autoimmune diseases.

96
article thumbnail

Lilly trumpets early success with deafness gene therapy

pharmaphorum

Eli Lilly’s gene therapy for otoferlin-related deafness has restored the hearing of the first child enrolled in its ongoing phase 1/2 trial

92
article thumbnail

Why Your Brand Strategy is Essential to Your Healthcare Digital Marketing Success

Healthcare Success

Digital marketing strategies fail when they’re not aligned with your brand. Picture this: a cardiac center that prioritizes personalized care and leading-edge technology. This brand champions expertise, compassion, and patient empowerment. What would happen if the marketing department of this brand launched a social media campaign featuring younger hospital staff doing a trendy dance?

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

Trial raises hopes for simple Alzheimer’s blood test

pharmaphorum

Study finds evidence that an AlZpath immunoassay for phosphorylated tau could deliver an effective blood test for Alzheimer's, paving the way for screening and early treatment

79
article thumbnail

Researchers advance blood tests’ ability to detect cancer earlier

PharmaTimes

The advancement could allow earlier detection of cancer in the blood and better treatment

99
article thumbnail

Sanofi snaps up Inhibrx and its rare disease drug for $2.2bn

pharmaphorum

Sanofi agrees $2.2bn deal to buy California biotech Inhibrx and its long-acting therapy for rare disease AATD, which causes life-threatening emphysema.

83
article thumbnail

MIT researchers repurpose cancer compound to treat PKD

PharmaTimes

Autosomal dominant polycystic kidney disease affects more than 12 million people globally

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.

article thumbnail

Digital marketing firm Viseven gets private equity backing

pharmaphorum

Ukraine-based digital pharma marketing specialist Viseven gets private equity investment from Horizon Capital

article thumbnail

Will A.I. Replace the Medical Sales Workforce and Surgeons? With Edouard Saget

Evolve Your Success

In the changing balance between innovation and tradition, medical sales succeeds with personal connection, persistence, and the commitment to link technology and patient care. For today’s episode, we have Edouard Saget to discuss the big question: Will AI replace medical sales workforce and surgeons? Edouard shares his journey from a 1099 sales rep to the founder of OrthoGrid Systems , a groundbreaking venture to enhance surgical procedures.

article thumbnail

How TPAs Can Use Network Design as a Competitive Advantage

Clarify Health

Finding and maintaining affordable healthcare plans is challenging for businesses that lack the expertise and resources to navigate a complicated landscape. That’s why organizations are turning to third-party administrators (TPAs), licensed entities that help administer healthcare benefits for self-funded plans. With deep expertise in the healthcare and insurance fields and in-depth knowledge of industry standards, laws, and regulations, they can help businesses plan health benefits, str

article thumbnail

Gilead's Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

PharmExec

The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.

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

Pharma R&D productivity dips, but efficiency gains give hope

Clarivate

The Centre for Medicines Research (CMR) International, a Clarivate business, publishes the Pharmaceutical R&D Factbook, an annual report designed to equip the Pharmaceutical R&D sector with a reliable quotable source of key reference metrics and predictions used to strengthen the planning and effectiveness of R&D. The just-published 2023 Factbook indicates an industry that is becoming more nimble and efficient in its R&D over the long haul.

Pharma 52
article thumbnail

CNPR Certification Reviews - Cracking the Code to Pharmaceutical Sales Success

Contrarian Sales Techniques

Craving a career in the lucrative world of pharmaceutical sales? Ever heard of the CNPR certification, the industry's golden ticket to success? Maybe you're a driven newbie seeking your first foot in the door, or perhaps a seasoned professional aiming to climb the career ladder. Whatever your goals, the CNPR, or Certified National Pharmaceutical Representative title, might just be the key that unlocks your pharmaceutical dreams.

article thumbnail

SPOTIO and Solo Elevate Solar Sales Experience with Advanced Integration Features

Spotio

Dallas, TX – January 23, 2024 – SPOTIO, the leader in field sales engagement technology, and Solo, the all-in-one solar growth and proposal platform, are excited to announce an enhanced native integration that will redefine efficiency and effectiveness in the solar sales sector. For modern outside sales teams, the technology they use in the field is becoming a critical component of future growth strategies and ongoing success.

article thumbnail

Gen Z Loves Libraries

Copyright Clearance Center

If you think that libraries are just for books and that kids today care only about digital media, then you should read a new report from the American Library Association.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.