Mon.Jul 10, 2023

article thumbnail

Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks

Fierce Pharma

Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbust | Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.

Medicine 310
article thumbnail

The AI Revolution Has Arrived: Shaping the Next Generation of Pharma Marketing

PharmExec

Join five industry leaders as they unpack the transformative potential of artificial intelligence in the pharmaceutical industry, offering insights into real-world applications and the future of life sciences marketing in an era shaped by rapid technological evolution.

Marketing 119
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

Samsung Biologics, after expanding Pfizer collab, inks Novartis production deal worth $391M

Fierce Pharma

Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pac | Samsung Biologics said in a Monday regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier tie-up worth $81 million.

239
239
article thumbnail

Hospitals Have Concerns About CMS’ Proposed $9B Lump Sum Payment for Illegal 340B Cuts

MedCity News

CMS recently proposed a $9 billion lump sum payment to remedy illegal payment cuts for 340B drugs from 2018 to 2022. In general, hospital groups have reacted positively to the fact that 340B providers will receive lump sum payments but have expressed concern about CMS’ methods for maintaining budget neutrality with this plan.

Biopharma 101
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Novartis pledges to appeal after Delaware court nixes patent on big-selling Entresto

Fierce Pharma

After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appe | After a Delaware district court ruled a 2025 Entresto combination patent is invalid, Novartis will head to the U.S. Court of Appeals for the Federal Circuit in an effort to reverse the decision.

189
189
article thumbnail

Harnessing AI for Pharma Sales

PharmExec

Artificial intelligence is steadily becoming a game changer for the pharma industry, particularly in commercialization activities, such as sales and marketing—and efforts to help highly sought treatments reach the right patients.

Sales 98

More Trending

article thumbnail

Crossing the Brain Barrier

PharmExec

COMPASS Pathways’ CEO, Kabir Nath, has a clear vision for psychedelics—and is leading the way with the company’s focus on psilocybin and efforts to separate the science from the hype.

Leads 98
article thumbnail

EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. The regulatory body has amended Q&A 10 to include the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N -nitrosamines. The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal produ

article thumbnail

Enhancing Efficiency in your Practices: Unleashing the Power of Greenway Health’s Optimization Services [Sponsored]

MedCity News

Resolve your healthcare information technology concerns by optimizing your technology, boosting workflows, improving staff productivity, and driving revenue.

article thumbnail

On the clock: a collaborative approach to advancing adoption of RMM

European Pharmaceutical Review

Traditional methods for assessing microbial contamination in pharmaceutical products can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. Eur. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph. Eur. 2.6.7). Given their short shelf-life, there is a need for methods that generate more rapid results for emerging advanced therapy medicinal products (ATMPs) such as cell and gene therapies.

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

J&J Gets Foothold in Head & Neck Cancer With Deal for Nanobiotix’s Lead Program

MedCity News

Johnson & Johnson is committing up to $60 million for global rights to a Nanobiotix therapy that enhances radiation treatment for head and neck cancer. A Phase 3 test of the nanoparticle-based therapy is expected to yield preliminary data in 2024.

Leads 77
article thumbnail

The power of rapid methods for fungal ID

European Pharmaceutical Review

Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism. Spoilage not only affects the therapeutic properties of a product but may also discourage the patient from taking the medication.

article thumbnail

The Power of Rebranding: How Website Rebranding Drives Increased Traffic

Pharma Marketing Network

In today’s digital landscape, a website serves as a vital touchpoint for businesses to connect with their target audience. However, over time, a website can become outdated, lose relevance, or fail to resonate with visitors. When done strategically, rebranding a website can breathe new life into your online presence and significantly boost traffic.

article thumbnail

Titanium dioxide (E171) and its role in formulation

European Pharmaceutical Review

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes. In the development of a new drug product, it is necessary that each dosage form or strength incorporates mechanisms that enable its unique identification.

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

Work-Life Balance in Medical Sales

MedReps

Working in medical sales can be time-consuming. It’s easy to fall into the habit of working every minute of every day and not putting any boundaries into place for your personal life. After all, you need to set and attend client appointments, respond to phone calls and messages, complete all of the required reporting and paperwork, document sales, follow up with customers and so on.

article thumbnail

Capsule formulation: future trends

European Pharmaceutical Review

What recent advancements have been made in pharmaceutical capsules? Gelatine also poses potential long-term performance challenges” Several major trends have emerged in recent years in the capsule space. First, we are seeing growing demand for new materials to replace the traditional gelatine capsule shell. One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who, for dietary reasons, do not want to consume animal products.

article thumbnail

Digital Health’s H1 Funding Landscape: Slimmer Checks, Fewer Deals & a Smaller Investor Pool

MedCity News

The digital health sector has entered a new era when it comes to funding, and startups in this space must quickly adjust to an investment landscape that is characterized by lower check sizes, fewer deals and smaller cohort of investors. If things continue at the pace the sector has maintained throughout the first half of the year, 2023 will mark the field’s lowest yearly fundraising total since 2019, according to a new report.

74
article thumbnail

Ways to Spice Up Your Sponsorships in the Pharmaceutical Industry

Pharma Marketing Network

Sponsorships are a great way for pharmaceutical companies to connect with their target audience and promote their products or services. However, traditional sponsorships can be somewhat stale. If you want your sponsorships to stand out, you need to find ways to spice them up. Here are a few ideas: Get creative with your event sponsorships: Instead of just sponsoring a generic trade show booth, get creative with your event sponsorships.

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

Janssen reveals new Spravato data

PharmaTimes

Period to remission was shortened with esketamine nasal spray in both sub-groups within study - News - PharmaTimes

88
article thumbnail

Do AI Chatbots Improve Patient Engagement?

Referral MD

Healthcare is a shining example of creative development in the quickly evolving world of digital technology. The emergence of AI chatbots is one of the most significant trends changing this environment. These intelligent digital assistants are revolutionizing how healthcare providers interact with patients, boosting engagement, streamlining support services, and enhancing patient experiences.

article thumbnail

GSK’s Arexvy authorised by MHRA

PharmaTimes

Therapy is the first respiratory syncytial virus vaccine specifically developed for older adults - News - PharmaTimes

86
article thumbnail

Fiber Probes to Investigate Brain-Gut Relationship

Medgadget

Engineers at MIT have developed a microelectronic probe that can measure and influence the behavior of neurons involved in the brain-gut axis. Neural communication between the brain and GI tract has been implicated in a range of conditions as varied as autism and Parkinson’s disease. However, studying the interplay between these neurons was difficult, until now.

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

Humana Report: Health-related Social Needs Prevalent Among Dual-eligible and Non-dual-eligible MA Enrollees

MedCity News

A Humana study in Health Affairs found that 80% of dual-eligible beneficiaries had at least one health-related social need in 2019, compared to 48% of non-dual-eligible enrollees. While prevalence was higher in dual-eligible enrollees, non-dual-eligible enrollees shouldn’t be overlooked, researchers said.

64
article thumbnail

6 Steps to Create an Automated Field Sales Funnel

Spotio

What does every sales team want? More leads, faster. Of course, wanting leads and getting them are two different things. Fortunately, an automated sales funnel is the perfect tool to help you connect with and sell to new customers. In this article, we’ll discuss what an automated sales funnel is, why it can be so beneficial to sales teams like yours, how to build one in six easy steps, and more.

Sales 52
article thumbnail

Report: Those With Limited English Proficiency Are More Likely to be Uninsured

MedCity News

Of nonelderly people with limited English proficiency in 2021, 29% were uninsured, versus 9% of English proficient people, according to a new KFF analysis.

62
article thumbnail

DE&I in Pharma: A Shared Aim Promoting Inclusivity from Non-Leadership Roles

PharmExec

In today's changing workplace environment—one forever altered by the pandemic and the new approaches it spawned—employees at all levels play a vital role in developing and advancing inclusive behaviors across an organization and beyond.

Pharma 52
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

Mastering Sales Skills in Malaysia: Unleashing Your Potential

Contrarian Sales Techniques

Elevating Sales Performance with Effective Sales Training in Malaysia Are you looking to enhance your sales skills and boost your performance in the dynamic market of Malaysia? Look no further! Sales training in Malaysia is the key to unlocking your potential and achieving remarkable success in the competitive sales landscape. By equipping yourself with the right knowledge, techniques, and strategies, you can sharpen your sales acumen and take your career to new heights.

Sales 52
article thumbnail

Discovering Kate Therapeutics

Zymewire

Building partnerships in our fast-paced industry requires timing and context so that service providers can align their offerings with the specific needs of their ideal customer profile (ICP). Join us as we resurface our Sponsor Atlas Series, where we break down various biotech & pharma companies from all angles, to help you forge collaborative relationships.

Pharma 52
article thumbnail

Microfluidic Chip Aids Tuberculosis Diagnosis

Medgadget

Researchers at the University of London have collaborated with QuantuMDx, a medtech company based in the UK, to develop a microfluidic diagnostic device for tuberculosis. The CAPTURE-XT chip is designed to concentrate and purify Mycobacterium tuberculosis from suspected tuberculosis patients, particularly in areas that lack access to routine diagnostic technologies.

article thumbnail

Large Clinical Trial Supported Leqembi's Full Approval

PharmExec

The confirmatory study—which tracked 18 months of data—helped clear the way for new Alzheimer’s drug.

75
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.