Sat.Jun 24, 2023 - Fri.Jun 30, 2023

article thumbnail

Better Data Quality Means a Better Future for Public Health

MedCity News

Public health is heavily dependent on collecting and sharing accurate patient data. Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organizations to take ownership of their data quality by following best practices and adopting technologies that can detect and eliminate bad patient data before it is disseminated.

article thumbnail

AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert

Fierce Pharma

AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.

354
354
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

Pharma customer experience in the US faces an inflection point

Dominic Tyer

The latest Customer Experience Quotient® (CXQ®) report from DT Consulting is also our first US benchmark and reveals a close race for leadership in pharma

Pharma 130
article thumbnail

Unveiling the Journal Citation Reports 2023: Supporting research integrity with trusted tools and data

Clarivate

In the 2023 release of our Journal Citation Reports, we have taken significant additional steps to foster research integrity in the Web of Science. This is part of our ongoing efforts to proactively contribute to the maintenance of public trust in scientific and scholarly research. Learn about what’s new and some future changes. Today marks the 2023 release of the annual Journal Citation Reports (JCR ).

article thumbnail

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.

article thumbnail

NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

128
128
article thumbnail

BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors

Fierce Pharma

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

Doctors 348

More Trending

article thumbnail

In Depth Focus QA/QC Microbiology/RMM 2023

European Pharmaceutical Review

A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.

Safety 105
article thumbnail

Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

article thumbnail

Former Pfizer employee charged with insider trading, using advance information on Paxlovid trial

Fierce Pharma

A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.

334
334
article thumbnail

Lawsuits Against Medicare Drug Negotiations Are Mounting, But They Probably Won’t Be Able to Stop The Plan

MedCity News

Lawsuits filed in opposition to the White House’s drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government’s ability to negotiate price goes into effect.

article thumbnail

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

article thumbnail

Microbiome therapies: a maturing movement

European Pharmaceutical Review

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

article thumbnail

Genprex’s Reqorsa gene therapy secures another FDA fast-track designation

Pharmaceutical Technology

Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.

FDA 105
article thumbnail

Missed trial protocols, fabricated emails and failed endpoint mar BioXCel's Alzheimer's agitation readout

Fierce Pharma

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.

FDA 318
article thumbnail

How Telemedicine Can Combat Clinician Burnout, the Biggest Challenge Facing the Healthcare Industry

MedCity News

To fully reap the benefits of telemedicine, it is crucial to provide comprehensive education to both staff and patients. Clinicians, doctors, and other medical care providers should all be trained on telehealth software — its functionality, integration into their workflow, effective communication during consultations, and where to seek technical assistance.

Doctors 114
article thumbnail

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

article thumbnail

Alzheimer’s vaccine granted Fast Track designation

European Pharmaceutical Review

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

article thumbnail

A pharma summer — how leaders unwind and recharge their teams in the warmer months

PharmaVoice

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.

Pharma 102
article thumbnail

Change of guard at drug price watchdog: ICER founder Steve Pearson to step down after 17 years

Fierce Pharma

After growing the Institute for Clinical and Economic Review (ICER) into an influential drug pricing watchdog, Steve Pearson, M.D., is stepping down. | After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down.

301
301
article thumbnail

Eli Lilly’s Triple Mechanism Sets New High Mark for Weight Loss Drugs

MedCity News

Eli Lilly’s retatrutide led to an average weight reduction of 24.2%, or 58 pounds, after 48 weeks of treatment in Phase 2 testing. Based on these results, Lilly now plans a comprehensive Phase 3 program that will evaluate the once-weekly injectable drug in weight reduction as well as various complications of obesity.

Biopharma 114
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

Genfit and Ipsen announce elafibranor results

PharmaTimes

ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes

article thumbnail

Global PAT market expected to exceed $10b in 2032

European Pharmaceutical Review

Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us has found. With PAT being widely used in pharma, rising R&D expenses are anticipated to boost demand for these technologies. Growth and limitations in the global PAT market The PAT market is expected to grow $10.6 billion in 2032, the report suggested.

article thumbnail

FDA blesses CellTrans' Lantidra, the first cell therapy for Type 1 diabetes

Fierce Pharma

Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. | Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes.

FDA 290
article thumbnail

UCSF Spinout Raises $12M for Platform That Facilitates Secure AI Development

MedCity News

BeeKeeperAI — which offers a platform to facilitate the development and deployment of healthcare AI models — raked in $12.1 million in Series A funding led by Santé Ventures. The startup was spun out of UCSF last year.

article thumbnail

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

article thumbnail

Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy

Pharmaceutical Technology

The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.

FDA 98
article thumbnail

First cell therapy approved for Type 1 diabetes

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.

article thumbnail

UCB finally gets a win with the FDA, scoring approval for myasthenia gravis drug Rystiggo

Fierce Pharma

This has been a second straight year of regulatory struggles in the United States for UCB with one of the those issues revolving around the FDA needing additional time to

FDA 279
article thumbnail

Eyenuk’s New FDA Clearance Could Boost Adoption for Its Diabetic Retinopathy Screening Tech

MedCity News

Eyenuk recently received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system, which automatically detects diabetic retinopathy. The company said this FDA clearance makes its system the only AI system that is FDA-cleared for use with multiple retinal cameras produced by different manufacturers.

FDA 111
article thumbnail

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

article thumbnail

Q&A: How can the US maintain access to essential drugs?

Pharmaceutical Technology

Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.

article thumbnail

CCC Named a Stevie® Award Winner for Customer Service Department of the Year in the 2023 American Business Awards®

Copyright Clearance Center

The post CCC Named a Stevie® Award Winner for Customer Service Department of the Year in the 2023 American Business Awards® appeared first on Copyright Clearance Center.

98
article thumbnail

Lundbeck replaces retiring CEO Dunsire with UCB exec after breaking sales record

Fierce Pharma

Lundbeck CEO Deborah Dunsire is stepping down on a high note in the neuroscience company’s history. | Lundbeck CEO Deborah Dunsire is retiring on a high note in the neuroscience company’s history. After hitting the company's highest quarterly revenue in the first quarter, the five-year Lundbeck chief executive will pass the baton to UCB's neurology head.

Sales 278
article thumbnail

Survey: Employers Aren’t Doing Enough To Support Employees’ Mental Health

MedCity News

A Northeast Business Group on Health survey, published Monday, found that 26% of employers never identify the needs of employees, nor the “awareness and effectiveness” of their mental health programs. About three in ten respondents don’t have messaging campaigns through social media and internal platforms on mental health.

Media 111
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time