Thu.Jun 23, 2022

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Eisai’s brain health tool NouKNOW used in Tokyo dementia project

pharmaphorum

Eisai’s digital tool to allow self-assessment of cognitive performance – NouKNOW – will be used in a Japanese project aimed at improving the management of dementia. The smartphone app – which uses a cognition-checking algorithm developed by Australian digital health company Cogstate – will be deployed in Bunkyo City, Tokyo in a dementia monitoring programme.

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Telehealth visits for mental health continue to rise despite dropping in every other specialty

MedCity News

Mental health is bucking the overall trend in telehealth utilization. A new report found that telehealth accounted for 87% of mental health appointments booked last month. That percentage is continuing to climb, despite virtual care visits declining across all other specialties.

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'Nobel Prize of pharma' helps put Huma's digital health platform on the global map

PharmaVoice

The company’s CEO explains how its Prix Galien award-winning app bridges patient care, treatment support and clinical research.

Pharma 130
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Medallion gets a $35M boost to continue its goal of removing inefficiencies in provider management

MedCity News

Medallion — a provider management platform that automates licensing, continuing education tracking, credentialing and compliance — has completed three funding rounds in one year. On Thursday, it closed a $35 million Series C round, which will be used to help the startup attract more hospital and health system customers.

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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

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EC approves Novartis’ Tabrecta for non-small cell lung cancer

Pharmaceutical Technology

The European Commission (EC) has approved Novartis’ Tabrecta (capmatinib) as a monotherapy to treat advanced non-small cell lung cancer (NSCLC) in adults. The treatment is intended for patients with NSCLC harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping and for those who need systemic therapy after previous treatment with immunotherapy and/or platinum-based chemotherapy.

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Specialty pharmacy serving HIV patients wins arbitration against CVS in rare public case

MedCity News

Confidentiality agreements typically prevent the public from obtaining a window into the cases against pharmacy behemoths but a public court filing makes this one different.

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Biopharma firm Radius Health is going private in an $890M M&A deal

MedCity News

Two private equity firms have reached an $890 million deal to buy Radius Health, a company whose main asset is the commercialized osteoporosis drug Tymlos. In other M&A news, cancer biotech F-star Therapeutics is being acquired in a $161 million deal.

Biopharma 104
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Precision Bio climbs on near-$1.5bn sickle cell pact with Novartis

pharmaphorum

Novartis has shouldered its way into the in vivo gene editing category via a deal with US biotech Precision BioSciences, focused on a therapy for sickle cell disease (SCD). The Swiss pharma group is paying $75 million upfronting cash and equity to get the ball rolling on the collaboration, with another $1.4 billion in potential milestones if the project advances through development and onto the market.

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Which clinical trial innovation startups will present at INVEST PharmaTech Pitch Perfect?

MedCity News

The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.

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Spotlight on Women in Science: Giulia Guerrini

pharmaphorum

Around the world, women are making important contributions to life sciences. In this series, we chart the career progression of notable women across the industry to find out what drew them to study science and how we can encourage more women to consider a role in STEM. In this edition, Giulia Guerrini, the lead pharmacist for digital pharmacy medino, discusses her journey from classics student in Italy to start-up superintendent and why it’s important to champion women in leadership positions.

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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.

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How health tech can improve the patient and provider experience [Sponsored]

MedCity News

Leaders in healthcare draw attention to the myriad ways cloud computing technology is transforming healthcare.

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Strategies for Creating a Recession-Proof Business

Integrity Solutions

It’s the “r” word no one wants to utter, but many experts worry that a potential recession could be looming somewhere out there on the horizon. While the data doesn’t suggest a major downturn is imminent, and things like strength in the labor market and financial system could fend it off entirely, there are numerous warning signs that have economists cautioning that “the economy faces headwinds.” And for many salespeople it will be the first recession theyR

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Non-stop investment from CMOs and US Government into continuous manufacturing

Pharmaceutical Technology

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream.

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Pharma poised but no recorded monkeypox deaths

PharmaTimes

Global surveillance systems show that recorded cases do not include any deaths

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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.

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US FDA grants approval for Merck’s pneumococcal vaccine for children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The vaccine is intended for active immunisation to prevent invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in people aged six weeks and above.

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Novartis invests $250m in malaria elimination commitment

PharmaTimes

The company has renewed its pledge to eliminate neglected tropical diseases and malaria over five years

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New pricing rules lower access barriers for orphan drugs in France

Pharmaceutical Technology

As recent changes to the price setting of drugs have improved the market access risk environment in France, GlobalData looks at their impact on the pricing of orphan drugs. Changes to price negotiations positive for orphan drugs. The changes in question were introduced via the new contractual agreement signed by the French Pharmaceutical Companies Association (LEEM) and the Ministry of Health’s (MoH’s) Economic Committee for Health Products (CEPS) in March 2021.

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4 tips for landing your next C-suite role in pharma

PharmaVoice

Even execs get the blues — and when they’re ready for a fresh start, Leslie Loveless, CEO of Slone Partners, says these dos and don’ts could make or break their next job move.

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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.

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Building Successful Teams from Scratch

Rep-Lite

Can you imagine building a medical sales team from scratch? Is it even possible to organize a new group of competent sales representatives to go to the field and compete with other medical rep sales companies? The answer is yes! Rep Lite is here to provide you with the best people to fill your sales rep jobs and comprise a success-driven team you have never had.

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The Metaverse: Regulatory trends

Pharmaceutical Technology

The metaverse will make digital media experiences more immersive, inclusive, and accessible than today. However, it will raise social concerns ranging from data privacy to other forms of online harm. Listed below are the key regulatory trends impacting the metaverse theme, as identified by GlobalData. Net neutrality. Net neutrality refers to the concept that a telecom network should be a neutral gateway to the Internet rather than a gatekeeper with the power to decide what content is available o

Media 52
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Insights on antineoplastic and immunomodulating therapies patent landscape to drive litigation strategy

Clarivate

In our new oncology report, we analyzed paragraph IV certification and post-grant patent litigation trends impacting generic drug strategies on antineoplastic and immunomodulating therapies. Our analysis suggests notably that the jurisdictions chosen for infringement and validity challenge cases over the past 10 years are changing, and past favorites may no longer be the most strategic. .

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UNH team finds repurposed drug hinders enzyme activity linked to Covid-19

Pharmaceutical Technology

Researchers at the University of New Hampshire (UNH) have found that a repurposed drug, CCG-50014, could hinder the activity of a key enzyme of the SARS-CoV-2 virus, which causes Covid-19. Utilising a currently available drug compound in a new way is called drug repurposing. The main protease enzyme Mpro, a key enzyme related to Covid-19, was the key target of the team in the study.

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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.

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Antibody drug conjugates and bispecifics seize the spotlight at ASCO 2022

Clarivate

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. One trend stood out clearly: the prominence of innovative treatments, including antibody drug conjugates (ADCs) and bispecific antibodies. ADCs and bispecifics aren’t new.

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The Metaverse: Macroeconomic trends

Pharmaceutical Technology

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. This shift will be driven by the future of work and digital transformation initiatives ongoing across sectors ranging from retail to healthcare and financial services. Big Tech is championing the metaverse, with Microsoft and Meta promoting it as the ideal environment to support hybrid working.

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Enanta lawsuit claims Pfizer’s Paxlovid infringes its patent

pharmaphorum

US biotech Enanta Pharma has filed a lawsuit against Pfizer, claiming that its oral antiviral for COVID-19 Paxlovid infringes one of its patents and seeking damages from the pharma giant. The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and wa

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Unlocking the potential of direct-to-patient as decentralised trials continue to grow

Pharmaceutical Technology

The global healthcare and pharmaceutical industry is frequently faced with having to find new ways of innovating and carrying out its work in order to overcome tragic circumstances that will typically come with a huge human cost. During the peak of the Covid-19 pandemic this challenge reached new heights, as pharmaceutical firms around the world mobilised the full might of their resources to try and identify, develop, and trial a wide range of vaccines and therapeutics to alleviate the lethal th

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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

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Novartis bags FDA okay for BRAF-positive tumour combination

pharmaphorum

Novartis’ two-drug regimen of Tafinlar and Mekinist has been approved by the FDA as the first therapy for solid tumours that have a BRAF V600E mutation – regardless of where they occur in the body. The so-called “tumour-agnostic” indication for BRAF inhibitor Tafinlar (dabrafenib) and MEK inhibitor Mekinist (trametinib) covers patients aged six and over with tumours that have progressed after earlier treatment and have no alternative therapies available.

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Robotics hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for robotics related positions rose in May 2022 compared with the equivalent month last year, with 20.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 19.7% of companies who were hiring for robotics related jobs a year ago but a decrease compared to the figure of 21.8% in April 2022.

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Building Networked Innovation

Copyright Clearance Center

The post Building Networked Innovation appeared first on Copyright Clearance Center.

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Creating A Space For Women’s Health

PharmExec

In episode 111, Kevin Ali, CEO of Organon, talks about how’s he’s lead the launch of a new niche company for women’s health, and what he hopes it can achieve.

Leads 52
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.