Tue.Nov 21, 2023

article thumbnail

Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

357
357
article thumbnail

Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Pharma 141
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

Texas accuses Pfizer and contract manufacturer of providing ineffective ADHD drug to state's Medicaid program

Fierce Pharma

Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades.

article thumbnail

Merck Neuroscience Acquisition Brings a Startup With Parkinson’s, ALS Programs

MedCity News

Merck’s acquisition of Caraway Therapeutics adds programs for genetically defined neurodegenerative diseases. One of those programs addresses a target that was the focus of a different startup purchased by Merck in 2019.

Biopharma 121
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

GSK aims to slash carbon emissions with next-generation inhaler

Fierce Pharma

Joining drugmakers like AstraZeneca and Novo Nordisk, GSK is making big strides in its quest to clean up its carbon footprint. | GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%.

280
280
article thumbnail

Remote Patient Monitoring: Pioneering Healthcare Through Quality Assurance

MedCity News

RPM has ushered in a new era of healthcare. However, navigating the complexities and challenges of this landscape requires a thoughtful QA strategy.

More Trending

article thumbnail

Why Boulder Care’s CEO Is Hopeful About the Future of Substance Use Disorder Treatment

MedCity News

The DEA proposed a rule back in March that would roll back some of the Covid-19 flexibilities for the virtual prescribing of controlled substances, but has since extended the flexibilities. Stephanie Strong, founder and CEO of Boulder Care, feels confident that the DEA will continue to be open to the prescribing of these medications via telemedicine.

Medical 111
article thumbnail

Bayer's trial flop, courtroom setback could restrict CEO's options amid strategic review: analyst

Fierce Pharma

After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. | After suffering setbacks in the clinic and in court this week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends.

236
236
article thumbnail

GSK propels its progress to Net Zero

European Pharmaceutical Review

Phase III trials of a low carbon version of GSK’s metered dose inhaler, Ventolin (salbutamol), using a next generation, lower carbon propellant, are set to start in 2024. The pharma company stated that if successful, it has the potential to reduce greenhouse gas emissions from use of the inhaler by approximately 90 percent. According to GSK, thirty-five million patients with respiratory conditions globally relying on its metered dose inhaler.

article thumbnail

What Health Plans Wish the Healthcare Innovation Ecosystem Knew

MedCity News

A California payer lays out the three things she wishes all entrepreneurs knew about how to bring their ideas to market most effectively and initiate successful collaboration.

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

What Makes A Good Medical Sales Rep With Rob Bahna

Evolve Your Success

Success in medical sales is not only about knowledge, but also about the application of that knowledge, adapting proactively, and being aware of your impact in the room. In this episode, we have Rob Bahna discuss what truly makes a good medical sales rep. From his early beginnings to climbing the ladder of success, Rob provides a firsthand account of his journey through various leadership positions in medical sales.

article thumbnail

Why 1 Health System Is Embedding Genomics Into Primary Care

MedCity News

At Northshore–Edward Elmhurst Health, all patients are offered genetic testing as part of their primary care visit. This helps clinicians create more personalized care plans and facilitates earlier disease diagnoses, said Kristen Murtos, the health system’s chief innovation and transformation officer.

Patients 108
article thumbnail

BRUKINSA® granted significant EU approval in follicular lymphoma

European Pharmaceutical Review

BRUKINSA ® (zanubrutinib) in combination with the anti-CD20 monoclonal antibody obinutuzumab, has been approved by the European Commission (EC) to treat relapsed or refractory follicular lymphoma in individuals who have received at least two prior lines of systemic therapy. The oral treatment is now “the first Bruton’s tyrosine kinase (BTK) inhibitor approved in this indication and has the broadest label of any medicine in its class globally,” stated Dr Mehrdad Mobasher, Chief Medical Officer, H

article thumbnail

How One Company Is Addressing Health Inequities in Eating Disorder Treatment

MedCity News

Eating disorders don’t discriminate. Equip, a virtual company that provides eating disorder support, is trying to reach different populations by having a diverse care team and working with advisors from different backgrounds, said Kristina Saffran, CEO and co-founder of the company.

107
107
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

Experts Believe Gene Therapy Offers Potential to Impact Gaucher Disease Market

Pharmaceutical Technology

According to several key opinion leaders (KOLs) interviewed by GlobalData, pipeline gene therapy holds the greatest potential to transform the Gaucher disease landscape

article thumbnail

BeiGene Strikes Deal for Global Rights to Ensem’s Phase 1-Ready Cancer Drug

MedCity News

BeiGene is expanding its cancer drug pipeline, landing global rights to an Ensem Therapeutics cancer drug candidate ready to enter the clinic. The drug targets CDK2, an enzyme whose excessive activity is associated with cancer progression.

Biopharma 103
article thumbnail

Two charities co-fund £5.5m childhood cancer research programme

PharmaTimes

SMPaeds2 aims to advance precision medicines for children with relapsed cancer - News - PharmaTimes

Medicine 108
article thumbnail

FDA delays assessment of BMS and 2seventy’s CAR-T therapy

Pharmaceutical Technology

The FDA's decision on the sBLA for Abecma will be delayed beyond the set PDUFA target date of 16 December.

FDA 98
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

Lab-grown blood vessels could potentially treat strokes and vascular dementia

PharmaTimes

Cerebral SVD contributes to 45% of dementia cases and 20% of ischaemic strokes - News - PharmaTimes

103
103
article thumbnail

UK launches medicines scheme with £400m earmarked for clinical trials

Pharmaceutical Technology

The new scheme will launch in 2024 and aims to save the National Health Service (NHS) £14bn over five years.

article thumbnail

An Examination of US Drug Shortages’ Impact on the Supply Chain

Pharmaceutical Commerce

IQVIA report explores why these shortages are increasing, and how they can be mitigated.

104
104
article thumbnail

GSK says new inhaler will help slash its carbon footprint

pharmaphorum

GSK says new inhaler will help slash its carbon footprint Phil.

98
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

Sales Strategy Consulting and Sales Process Consulting: A Complete Guide

Rep-Lite

Sales strategy consulting is a specialized form of management employed by a sales consulting firm that focuses on helping businesses improve their sales performance and achieve their revenue goals. So now that you have the gist of what sales strategy consulting is, let’s better understand what a sales consultant is. With over 30 years of experience in staffing medical and sales reps, clinical sales, and service positions, Rep-Lite can help you offload the burden of hiring sales professiona

article thumbnail

Can AI Coaching Platforms Actually Boost Sales Performance? Here’s What the Data Says

Quantified

In today’s ever-changing sales environment, professional coaching has risen to become a core need across industries. For organizations, better-coached employees lead to improved performance and productivity that drives a strong ROI. Meanwhile, workers across all skill levels now expect regular coaching from their employers. Rapid advancements in technology, market trends, and customer expectations require workers to continuously adapt and enhance their skills.

Sales 52
article thumbnail

MSD reaches $610m deal to buy lysosome biotech Caraway

pharmaphorum

MSD reaches $610m deal to buy lysosome biotech Caraway Phil.

89
article thumbnail

Unveiling Progress and Challenges: C diff Awareness Among Medical Professionals

Pharmacy Times

Christian John Lillis, co-founder and executive director at Peggy Lillis Foundation, discusses the role of the pharmacist in education that advances C diff awareness in the medical community.

Medical 63
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

MorphoSys shrugs off mixed results for myelofibrosis drug

pharmaphorum

MorphoSys shrugs off mixed results for myelofibrosis drug Phil.

87
article thumbnail

Prevention, Treatment for Migraine Rapidly Evolves, Calling for Development of Novel Drugs

Pharmacy Times

Zavegepant (Zavzpret; Pfizer) is the first and only only CGRP receptor antagonist as a nasal spray for the acute treatment of migraine in adults with and without aura approved by the FDA.

FDA 61
article thumbnail

BeiGene strikes deal worth $1.3bn with Ensem for CDK2 inhibitor 

Pharmaceutical Technology

Ensem will receive an upfront payment and will be eligible for additional payments upon the achievement of milestones, totalling up to $1.33bn.

52
article thumbnail

Current Trends, Treatment Strategies for C diff Infection

Pharmacy Times

Paul Feuerstadt, MD, FACG, AGAF, discusses insights in current treatment practices for CDI at the Peggy Lillis Foundation’s 2023 State of C diff Virtual Town Hall.

61
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.