Sanofi's Provention buyout hit with FTC delay. Will Pfizer's Seagen deal go off as planned?
Fierce Pharma
APRIL 11, 2023
Sanofi's Provention buyout hit with FTC delay. Will Pfizer's Seagen deal go off as planned?
Tue.Apr 11, 2023
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Cell Therapy Pioneers Team Up to Found Viral Vector CDMO Backed by $64M
MedCity News
APRIL 11, 2023
VintaBio manufactures AAV and lentiviral vectors for entities pursuing clinical development of cell and gene therapies. The contract development manufacturing organization’s launch comes as demand for viral vectors continues to outpace the supply of these crucial components of the therapies.
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US launches $5bn effort for new Covid-19 vaccines development
Pharmaceutical Technology
APRIL 11, 2023
The US government is reportedly investing more than $5bn in a programme to accelerate the development of new Covid-19 vaccines and treatments. Dubbed Project Next Gen, the new effort will follow an approach similar to that of Operation Warp Speed, which developed and delivered vaccines to Covid-19 patients in 2020 by forming private-public partnerships for the rapid development of new vaccines.
Tax Breaks Far Outweigh Community Spending at Most Nonprofit Hospitals
MedCity News
APRIL 11, 2023
A new report from Lown Institute examined the finances of 1,773 private nonprofit hospitals across the U.S. For more than three-quarters of these hospitals, their spending on charity care and community investment was less than the money they received in tax breaks in 2020. These combined deficits totaled $14.2 billion, which is enough money to relieve 18 million Americans’ medical debt or prevent 600 at-risk rural hospitals from closing, according to the report.
Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority
PharmaTech
APRIL 11, 2023
A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.
ReKlame Health Brings Addiction Medicine Treatment Into the Home
MedCity News
APRIL 11, 2023
Culturally competent behavioral health provider ReKlame Health is rolling out an in-home program for addiction medicine care in New York City. For patients diagnosed with alcohol use disorder, a registered nurse will come to their home on a monthly basis to administer Naltrexone LAI, a medicine that helps stop cravings for opioids and alcohol.
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Chinook Therapeutics Pauses Kidney Disease Drug Trial Following Adverse Event Report
MedCity News
APRIL 11, 2023
The serious adverse event reported in the early-stage study resolved quickly, but Chinook Therapeutics said it is suspected to be related to its experimental primary hyperoxaluria therapy. Meanwhile, Human Immunology Biosciences is looking ahead to Phase 3 after its rare kidney disease drug posted positive mid-stage data.
CCC Signs Bilateral Agreement with the Malaysia Reprographic Rights Centre (MARC)
Copyright Clearance Center
APRIL 11, 2023
April 11, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced it has signed a bilateral agreement with the Malaysia Reprographic Rights Centre (MARC) to support its operations and the development of copyright-compliant content consumption in Malaysia benefitting both rightsholders and content users.
Scientists discover non-invasive approach for cancer therapy
Pharmaceutical Technology
APRIL 11, 2023
Scientists at the Northwestern University in Illinois, US, have discovered a non-invasive approach to isolate a tumour’s attack cells from blood, rather than from tumours. The finding is expected to pave the way for adoptive cell therapy (ACT) to treat harder-to-reach cancer types. ACT harnesses immune cells collected from the patient’s own tumours to treat cancer.
How Modern Natural Language Processing Is Improving Healthcare
MedCity News
APRIL 11, 2023
Clinical-grade NLP is in the earlier stages of adoption, but as healthcare organizations continue to struggle with unstructured data and clinician burnout, we will see a gradual increase in its use. The AI and deep learning models being developed today in conjunction with medical NLP will be used in healthcare five, 10 and 20 years from now. These technologies will be so tightly integrated into EHRs that they’ll be almost invisible to end users.
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.
FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis
Legacy MEDSearch
APRIL 11, 2023
Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. The MISHA Knee System is indicated to treat people with medial knee OA who failed to find relief from non-surgical or surgical treatment, continue to experience pain that interferes with daily activities, a
MedArrive Rakes In $8M for Home Care Platform
MedCity News
APRIL 11, 2023
MedArrive’s new $8 million funding was led by Cobalt Ventures, a subsidiary of Blue Cross and Blue Shield of Kansas City. With the funding, the company will grow its team, as well as improve on its product and technology, said Dan Trigub, CEO and co-founder of MedArrive.
Unwavering Focus
PharmExec
APRIL 11, 2023
Christi Shaw, this year’s Healthcare Businesswomen’s Association (HBA) Woman of the Year, stays true to her beliefs—and life mission—of helping others.
The Social Job Search
MedReps
APRIL 11, 2023
Social media used to be a way for people to express themselves and stay connected with family and friends no matter how far away they lived. Over time, the uses of social media have expanded to the point where people are now using social platforms to find jobs and present themselves as knowledgeable candidates who are worth hiring. So, how can you use social media to find medical sales jobs to apply for?
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
Approaches for Understanding Data Quality in Ringgold Identify
Copyright Clearance Center
APRIL 11, 2023
The post Approaches for Understanding Data Quality in Ringgold Identify appeared first on Copyright Clearance Center.
How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development
MedCity News
APRIL 11, 2023
Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.
Moderna cancer vaccine takes positive step
PharmaTimes
APRIL 11, 2023
Company’s candidate, in combination with MSD’s Keytruda, receives PRIME designation
What is a Healthcare Writing Style Guide (& Why You Need One)
Healthcare Success
APRIL 11, 2023
You might remember writing style guides from college. Chicago Manual of Style, Associated Press, Modern Language Association? Instead of using a generic style guide for content, today’s leading healthcare brands are creating their own, also known as content style guides. A content style guide is a companion to your brand style guide and helps writers and marketers write on-brand copy for your business.
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.
Cerner Enviza and FDA partner to develop AI drug safety tools
Pharmaceutical Technology
APRIL 11, 2023
Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. Under the FDA’s drug safety Sentinel Initiative, the partnership will develop AI tools to collect key information from clinical notes within electronic health records (EHR).
MSD’s Keytruda given go-ahead by SMC
PharmaTimes
APRIL 11, 2023
Treatment concerns adults and adolescents with stage IIB or IIC melanoma skin cancer
Scott Burrows, Motivational Insurance Industry Speaker
Scott Burrows
APRIL 11, 2023
Flipping the Script on Public Distrust At the outset of this year, leadership in the insurance industry outlined the top challenges facing insurance sales reps in 2023. And as a motivational insurance speaker and former financial advisor, I know it is crucial to flip the script when it comes to communicating with your clients by recognizing how each new challenge represents the unique opportunity to forge stronger client connections and a deeper sense of loyalty.
Cancer center identifies $7.5M opportunity to grow referral-related revenue in one year
Clarify Health
APRIL 11, 2023
A nonprofit cancer and research center that is one of only 53 National Cancer Institute-designated Comprehensive Cancer Centers, wanted to identify referral patterns for primary care physicians (PCPs) and specialists in their market to have more productive, data-driven conversations with physicians about their referral patterns. Although their brand is well-known and respected for cancer treatment, they saw an opportunity to expand and diversify their physician list for referrals and align with
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.
Building Your Brand In Medical Device Sales With Pat Kothe
Evolve Your Success
APRIL 11, 2023
Building your brand in medical device sales requires experience, strategic insights, and a relentless pursuit of excellence. In this episode, Samuel Adeyinka interviews Pat Kothe , founder of a company specializing in medical devices for healing abscesses. With 40 years of medical device sales experience, Pat discusses how to build a successful medical device sales business.
7 Best Roofing CRM Software For 2023
Spotio
APRIL 11, 2023
If you’re a sales manager in the roofing industry, you know how competitive it can be. There are probably a dozen different companies vying for customers in your area—if not more. Fortunately, the demand for your services is on the rise. Experts predict the need for residential roofing will rise 0.7% per year, reaching 164.1 million squares in 2024.
Catalent Potent Drug Handing Capabilities
PharmaTech
APRIL 11, 2023
Catalent offers end-to-end solutions to accelerate drug development and market entry, with specialization in handling highly potent, hormonal, and cytotoxic compounds, integrating comprehensive risk assessment and controls for management and containment.
Core Values Series – Teamwork
Penrod
APRIL 11, 2023
At Penrod, we do our best to live by shared goals and values. Each Penrodian is introduced to our Core Values when they first join, and we encourage weekly shoutouts to keep that spirit alive. Here is the list of our five Core Values: Accountability Flexibility Growth Grit Teamwork Wanna learn more? Let’s take a dive into one of them: Teamwork! We define teamwork as “working together toward a common mission.
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
Sarepta announces May 12 date for DMD therapy’s reckoning at the FDA
Pharmaceutical Technology
APRIL 11, 2023
Sarepta Therapeutics has announced May 12 as the date of a highly anticipated US Food and Drug Administration’s (FDA) Advisory Committee meeting to consider the approval of its SRP-9001 gene transfer therapy for Duchenne muscular dystrophy (DMD). For Sarepta, the confirmation of meeting date is in contrast to the company’s initial expectations announced earlier this year that review of SRP-9001 would take place without an advisory committee.
The Fine Art of Method Development
PharmaTech
APRIL 11, 2023
The perfect complement for the Nexera Method Scouting System: LabSolutions MD, the first software to integrate all phases of HPLC method development following an Analytical Quality by Design approach.
CTRL announces funding for cell therapy platform development
Pharmaceutical Technology
APRIL 11, 2023
Biotechnology company CTRL Therapeutics has announced $10m in seed financing to boost the development of a next-generation cell therapy platform to treat solid tumours. Led by General Catalyst, the financing round was supported by Intermountain Health, FACIT, and other investors. The company will use the funding to further optimise and validate its technology platform, alongside expanding its team to support its initiative of offering curative therapies for cancer patients.
Idorsia Urges DEA to Deschedule Chronic Insomnia Drug Class
Pharma Leaders
APRIL 11, 2023
Idorsia Pharmaceuticals has petitioned the Drug Enforcement Administration (DEA) to deschedule dual orexin receptor antagonists (DORA), a class of chronic insomnia medications. Currently, the class is listed as Schedule IV under the Controlled Substances Act, which includes habit-forming drugs such as Valium and Xanax. The company argues that the DORA class “works differently, blocking signals in the brain that stimulate wakefulness addressing chronic insomnia without creating dependence and wit
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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