Fri.Jun 17, 2022

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Supreme Court Sides With Low-Income Hospital Groups In Decision About Drug Reimbursements

MedCity News

The Court unanimously ruled it was unlawful for HHS to adjust reimbursement rates for hospitals participating in the federal 340B program without first conducting a survey. The post Supreme Court Sides With Low-Income Hospital Groups In Decision About Drug Reimbursements appeared first on Above the Law.

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3 reasons to include medical affairs in selecting your MLR solution

Vodori

This is a co-authored blog post between Vodori and Marimac Insight, a scientific management consulting company. Considering a new medical, legal, regulatory review software solution at your pharma or device company is a big undertaking. Involving key stakeholders in this process is essential for success and a smooth transition to the new system. While marketing and regulatory teams often lead the promotional review process, it’s critical to include your medical affairs team in the system selecti

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With $110M in new funds, Aidoc is branching out of radiology

MedCity News

Aidoc, a Tel Aviv-based startup providing software to help radiologists triage scans, closed a $110 million funding round on Thursday. The company will use the money to expand its AI platform and develop care coordination tools for various specialties instead of focusing solely on radiology.

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Use Your Internship to Network for Your Career

Legacy MEDSearch

One of the most sought after experiences for many college students is to partake in an internship applicable to their studies. An internship can be extremely valuable, and an important aspect of an internship position is the significant opportunity to network with professionals already working in a particular field (…not to mention their field of interest!).

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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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Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months

MedCity News

Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.

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Creating Influence and Authority in Value-Based Healthcare

PharmExec

We may be only at the beginning of outcome-measured, value-based healthcare, but this is a chance for pharma organizations to show their mettle as roles are redefined and definitions of ‘value’ are agreed, says GĂ©rard Klop of Vintura.

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FDA User Fee Legislation Advances in Senate

PharmExec

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

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Novartis receives vital licence for Scemblix

PharmaTimes

Therapy represents the first STAMP inhibitor for patients with chronic myeloid leukaemia

Patients 101
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FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older

PharmaTech

FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

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StartUPDATES: New developments for healthcare startups

MedCity News

Check out news from Opala, Equiva, Sling Therapeutics, Quil, and Third Rock Ventures.

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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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Exothera, LogicBioTherapeutics, and Polyplus Collaborate on Industrial-Scale AAV Manufacturing

PharmaTech

Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.

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6 Ways To Keep Your Medical Device Distributor Engaged And Selling For You

Cesare Ferrari

As mentioned in this post , I think medical device distributors are not commodities ; on the contrary, they are key assets on which a company’s profitability is built, and this is the essence of medical device distributor management. For a medical device manufacturer, finding a valuable partner could be a challenge; it requires a rigorous process and a bit of luck.

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Aptamer Group Signs Deal with Flip Gene Therapeutics

PharmaTech

Aptamer Group has signed a deal with Flip Gene Therapeutics to support the development of inducible gene therapies.

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Amplifying Opinions of Patients & Caregivers for Higher Quality of Care

Impetus Digital

Pam Cusick , Senior Vice President of Rare Patient Voice , sat down with me in this Fireside Chat. Among many other thought-provoking topics, we dived into diversity, equity, and inclusion in Pharma and clinical trials; ways to enhance the patient’s voice in their treatment journey and health decisions; the major barriers to patient-centricity in clinical trials, and much more.

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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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Pain Regulation Gene Discovery Leads to New Treatment Target

PharmaTech

UK researchers have discovered a gene involved in chronic pain, which has created a new treatment target.

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Fireside Chat with Vlado Bosanac, Co-Founder & Head of Strategy and Revenue Growth at Advanced Human Imaging

Impetus Digital

Register for Impetus’ upcoming live webinar on June 29 , 10-11 AM ET : A Fireside Chat with Vlado Bosanac, Co-Founder & Head of Strategy and Revenue Growth at Advanced Human Imaging. About the webinar. Vlado Bosanac , Co-Founder & Head of Strategy and Revenue Growth at Advanced Human Imaging , will join Natalie Yeadon in this upcoming episode of Healthcare Goes Digital.

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Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands

PharmaTech

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

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Q&A With Paul Ford, co-founder and president, DS9 Capital

PharmExec

Ford discusses how rising drug costs in impact patients, and how they can either avoid them or find less-expensive options.

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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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MHRA to Play Greater Role in International Medicines Regulation

PharmaTech

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

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The Benefits of Enhancing Adverse Event Intake With Case Collection Systems

PharmExec

Automated risk management and improved regulatory compliance among opportunities offered by case collection.

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SCHOTT to Triple Vial Production Capacity in the US

PharmaTech

SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.

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MD Logistics to Open Sixth Warehouse

Pharmaceutical Commerce

New Garner, NC location will be its first outside the Midwest.

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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.

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Researchers Invent New Material that Can Capture and Release Biomolecules

PharmaTech

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

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27 Field Sales Management Tools For 2022

Spotio

Sales management is one of the most critical roles in a sales organization. Sales managers are asked to manage the entire sales cycle, ensuring all tools, processes, and of course, people work in unison toward a common sales target. As deals move through the sales cycle, the sales manager makes sure all players have what they need and are where they need to be to hit the target.

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Icosapent Ethyl Gains Nod from NICE

PharmaTech

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

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Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders to Address a Wide Range of Peripheral Embolization Cases

Legacy MEDSearch

Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System.

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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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Merck Collaborates with Agilent Technologies on PAT for Downstream Processing

PharmaTech

Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.

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BioCina Unveils pDNA Manufacturing Suite

Pharmaceutical Commerce

New service offering is GMP compliant, with single-use fermentation capacity of up to 300 L.

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CPHI China Opens its International Partnering Program After China Goes Up in CPHI Index

PharmaTech

CPHI China and P-MEC China has opened its online partnering platform after China experienced gains in the CPHI Pharma Index.

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Humanigen, PCI Pharma Services Enter Agreement for Lenzilumab Commercialization

PharmaTech

Humanigen and PCI Pharma Servicesare partnering up for the commercialization of lenzilumab.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.