Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy
Fierce Pharma
MAY 1, 2023
Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35
Mon.May 01, 2023
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Astellas Pharma agrees to buy Iveric bio for about $5.9bn
Pharmaceutical Technology
MAY 1, 2023
Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.
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Struggling Biogen paid its 2 CEOs more than $57M last year, including $30.5M to new chief Chris Viehbacher
Fierce Pharma
MAY 1, 2023
Struggling Biogen paid its 2 CEOs more than $57M last year, including $30.
Graphene Patch Affixes to Heart for Pacemaking
Medgadget
MAY 1, 2023
Researchers at Northwestern University and the University of Texas at Austin have developed a thin and flexible graphene “tattoo” that can be affixed to the outside of the heart, and which can monitor heart rhythms and apply corrective electrical impulses to treat arrhythmias. The patch is optically clear, allowing the researchers to also use light to monitor and stimulate the heart.
Pfizer, Astellas build case for Xtandi in early-stage hormone-sensitive prostate cancer
Fierce Pharma
MAY 1, 2023
Pfizer, Astellas build case for Xtandi in early-stage hormone-sensitive prostate cancer aliu Mon, 05/01/2023 - 09:56
A CEO’s quest to solve a 400-year-old medical mystery — and he’s also a patient
PharmaVoice
MAY 1, 2023
The CEO of Ventoux Biosciences has the disease that his company is aiming to treat, and it's driving him to find better medications.
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Is It Possible To Provide Equitable Nutritional Care for Diabetes and Obesity?
MedCity News
MAY 1, 2023
With obesity, diabetes, and heart disease rapidly growing among communities of color, we need to do everything we can to help people sustain healthy eating habits. It’ll take more nuance than a Westernized one-size-fits-all diet.
Wound Dressing Detects Infection, Changes Color
Medgadget
MAY 1, 2023
Researchers at Linköping University in Sweden created a wound dressing that can provide a visual indication if the underlying wound is infected. Chronic wounds are difficult to manage, and presently healthcare staff must remove the dressing regularly to check if an infection is developing. However, this can disrupt the wound by damaging the scab, impairing healing, and may even introduce pathogens in the process.
CVS Health: 60% of Mental Health Physicians See Patients’ Conditions Declining
MedCity News
MAY 1, 2023
New CVS Health data found that while 42% of respondents are concerned about their mental health, only 12% are seeing a mental health professional, such as a psychiatrist, psychologist, psychotherapist or wellbeing therapist. Younger respondents are especially struggling: 60% of those aged 18 to 32 years old are concerned about their mental health.
FDA Accelerates Approval for Qalsody, the First Treatment Targeting Genetic Cause of ALS
PharmExec
MAY 1, 2023
Biogen Inc. announced the approval, a groundbreaking treatment for adults with ALS, offering hope to patients suffering from SOD1-ALS, a rare and fatal genetic form of the disease.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Sanofi Finds Way to Maze Therapeutics to Get Its Next Pompe Disease Drug
MedCity News
MAY 1, 2023
Sanofi is acquiring rights to a Maze Therapeutics drug candidate for Pompe disease that could give the pharmaceutical giant another option to offer patients who have the rare metabolic disorder. In February, the drug posted positive data from a Phase 1 study.
Why Emotional Intelligence in Sales Creates Better Customer Relationships
Integrity Solutions
MAY 1, 2023
Many of our important decisions in life are influenced by both emotional and rational attributes, and often, the pull of the emotional is what rules the day. This simple truth goes a long way toward explaining why it takes more than just intellect and know-how to be a high-performing salesperson. As Daniel Goleman noted in his groundbreaking book , “Emotional Intelligence,” research shows that up to 90% of performance effectiveness is due to emotional savvy rather than technical know
Enrollment in MA Plans With $0 Premiums Is on the Decline, Report Finds
MedCity News
MAY 1, 2023
In 2023’s enrollment period, 84% of eHealth customers chose an MA plan with a $0 monthly premium, versus 87% in 2022, eHealth’s annual Medicare Index Report found. This is the first time popularity in $0 premium plans has decreased since eHealth started conducting the report in 2018, when 63% of customers selected a no-premium plan.
Emalex aims at a first-in-class breakthrough for Tourette syndrome
PharmaVoice
MAY 1, 2023
With its phase 3 candidate, the biotech believes it can move the field beyond antipsychotics to a more effective approach.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
60% of Nurses Have Plans to Change Their Job Status in the Coming Year, Study Shows
MedCity News
MAY 1, 2023
The burnout crisis among nurses has gotten significantly worse since the peak of the pandemic in 2021, according to new research from AMN Healthcare. Only 40% of nurses said that they have no plans to change their work status in the coming year, and only one-third said they have ideal time to spend with their patients — marking a decrease of 10 percentage points from 2021.
Bristol Myers Squibb boosts CAR T therapy manufacturing capabilities
European Pharmaceutical Review
MAY 1, 2023
After agreeing to acquire a US-based manufacturing facility and its operations from Novartis, Bristol Myers Squibb (BMS) adds in-house production of viral vectors to its capabilities. The facility in Libertyville, Illinois has the resources to produce viral vectors for BMS’s two CAR T-cell therapies, Abecma (idecabtagene vicleucel) and Breyanzi. This move will support the expansion of the company’s global cell therapy manufacturing network.
Eying Its Next Blockbuster, Astellas Lines Up $5.9B Iveric Bio Acquisition
MedCity News
MAY 1, 2023
Astellas Pharma is acquiring Iveric Bio in a deal that brings a vision loss-disorder drug on track for an FDA decision this summer. Iveric’s pipeline also includes genetic medicines that fit Astellas’s gene therapy strategy.
Teva, MedinCell receive FDA approval for Uzedy to treat schizophrenia
Pharmaceutical Technology
MAY 1, 2023
Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder. Developed using MedinCell’s SteadyTeq copolymer technology, Uzedy is the first subcutaneous, long-acting formulation of risperidone.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Connect These 3 Modern Medical Trends to Your Products
MedReps
MAY 1, 2023
Medical salespeople need to be adaptable. In order to make sales, they need to be aware of all of the related trends in healthcare, as well as know how to connect those trends to the products they sell. After all, physicians and other medical experts are aware of the trends and need to know how the products being offered fit, so it makes sense to include this information.
Patient Square Capital Launches Company to Support Medical Device Startups
MedCity News
MAY 1, 2023
Healthcare investment firm Patient Square Capital launched a new portfolio company: Elevage Medical Technologies. The company will support growth-stage medical device companies by providing capital, as well as operational and clinical expertise — it received an initial investment of $300 million from Patient Square.
Multilocation Marketing in Healthcare: The Biggest Challenges
Healthcare Success
MAY 1, 2023
Building a multilocation healthcare business expands your reach, patient base, and profit margin. But, these benefits come with several unique marketing challenges. The good news? They also come with remarkable marketing opportunities. In this article, I identify several common challenges and how to overcome them with effective marketing strategies. 12 Marketing Challenges Unique to Multilocation Brands Multilocation businesses typically prioritize revenue cycle management, billing, coding, coll
China’s NMPA grants priority review status for Ocumension’s Zerviate NDA
Pharmaceutical Technology
MAY 1, 2023
Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). This will expedite the regulatory approval process as well as the launch of Zerviate in the country, expected next year.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
The Art of Non-Confrontational Sales With Babe Kilgore
Spotio
MAY 1, 2023
Listen to the episode on Spotify. _ The Art of Non-Confrontational Sales With Babe Kilgore Babe Kilgore has spent his career mastering the psychology of direct sales and building sales companies. He has personally trained over 20,000 direct sales representatives through his sales and recruiting training mastery programs. Babe has taken multiple sales teams to the top in various industries.
CIRM grants funds to Ossium Health for OSSM-007 development
Pharmaceutical Technology
MAY 1, 2023
The California Institute of Regenerative Medicine (CIRM) has awarded $3.46m Clinical Stage Research Programme (CLIN1) grant to Ossium Health for advancing OSSM-007 development to treat steroid-refractory acute graft versus host disease (GVHD). OSSM-007 is the interferon-gamma primed mesenchymal stem cell product of Ossium Health. The grant will help in expediting pre-clinical and manufacturing activities of the product.
Transforming Healthcare Data to Precision Medicine
PharmExec
MAY 1, 2023
A modern healthcare ecosystem involves various stakeholders and many forms of complex data. Collaborations and a range of advanced approaches are essential to providing more uniform and complete healthcare to patients.
US FDA declines to approve Ascendis Pharma’s TransCon PTH NDA
Pharma Leaders
MAY 1, 2023
The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The regulator , in its complete response letter (CRL), mentioned concerns regarding the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
The Self-Improvement Industry
Contrarian Sales Techniques
MAY 1, 2023
A Booming Market with a Broader Scope The self-improvement industry is a massive and ever-growing market, providing an array of products and services aimed at helping individuals improve their personal and professional lives. The global self-improvement market was valued at around $38.1 billion in 2019, and experts predict it will skyrocket to almost $60 billion by 2027.
Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting
Legacy MEDSearch
MAY 1, 2023
BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session ( LBA01-05 ) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30 th.
How Personal Development Determines Sales Performance
Contrarian Sales Techniques
MAY 1, 2023
Unlocking the Key to Sales Success As a sales professional, you know that sales success is not just about having the right skills and knowledge. While these are important factors, personal development also plays a crucial role in determining your sales performance. In this article, we'll explore the connection between personal development and sales success, and how you can use this knowledge to improve your own sales performance.
FDA Approves Microbiome Therapeutic Vowst to Prevent Recurrence of C. difficile Infections in Adults
PharmExec
MAY 1, 2023
Seres Therapeutics and Nestlé Health Science celebrate the FDA's approval of Vowst, a first-of-its-kind orally administered microbiota-based therapeutic set to transform the lives of patients with recurrent C. difficile infections.
Accelerating Clinical Supply Through Integrated Drug Development
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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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