Wed.Sep 06, 2023

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J&J's patient assistance program suffers data breach, IBM says

Fierce Pharma

IBM disclosed "unauthorized access" to J&J’s Janssen CarePath patient assistance program, which helped over 1 million U.S. patients last year.

Patients 327
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A One-Time Treatment for NASH? Kriya Strikes Deal for Liver Disease Gene Therapy

MedCity News

Gene therapy biotech Kriya Therapeutics has acquired Tramontane Therapeutics, a startup focused on metabolic diseases. Tramontane brings a gene therapy that’s a potential one-time treatment for the fatty liver disease NASH.

Biopharma 113
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Astellas withdraws IRA lawsuit after avoiding CMS' price negotiations list

Fierce Pharma

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). | Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act. But now that the Centers for Medicare & Medicaid Services has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation.

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Orphan Drug Development Is Next for Tech to Tackle

MedCity News

Drug developers need policies and technological infrastructure to execute on their goal of being patient-focused. At a minimum, this means a compliant way to engage patients and truly hear their voices; at its most effective, patient engagement also meets patients where they are – whenever and wherever that may be.

Patients 108
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca hit with FDA rejection for Ultomiris in rare autoimmune disorder

Fierce Pharma

AstraZeneca’s Ultomiris expansion plan has hit a snag in the U.S. | The FDA handed the company a complete response letter for its Ultomiris application in neuromyelitis optica spectrum disorder, a rare autoimmune disease affecting the central nervous system.

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Integral Snags $7M In Seed Funding for Its Healthcare Data Privacy Platform

MedCity News

Integral raked in $6.9 million in seed funding in this week. The San Francisco-based startup is developing technology that seeks to speed up the process of exchanging sensitive health data while still maintaining robust privacy protection.

More Trending

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How Pitango VC Is Planning to Invest Its New $175M Health Tech Fund

MedCity News

Pitango Venture Capital, one of the largest venture capital firms in Israel, announced the first closing of a new $175 million healthcare technology fund. With the new fund, the firm plans to build a portfolio of approximately 15 new companies over a period of three to four years.

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Novartis cuts top commercial title, replaces departing exec Marie-France Tschudin with AbbVie vet Patrick Horber

Fierce Pharma

Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial offic | Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial officer title.

Pharma 218
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3 Ways to Use an Engineering Mindset to Optimize Patient Access Workflows

MedCity News

In a day of vast innovation, expansion, and acquisitions, an engineering mindset can bring a unique and effective approach to thinking across the system, evaluating the current and future state, standardizing on best practices, and considering upstream and downstream workflows.

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After manufacturing setback at FDA, Ascendis strikes $150M royalty deal on its first commercial drug

Fierce Pharma

Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. | Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues. Meanwhile, the company's Skytrofa is going up against a new competitor in Pfizer and OPKO Health's Ngenla.

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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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Delivering Precision Care to Manage Neurodegenerative Diseases

MedCity News

Precision medicine for neurodegenerative conditions has the potential to radically change the way patients are treated and managed over time. As an industry, we must continue to expand our thinking and push the boundaries of science, technology, and data analytics to capture precision medicine opportunities in broader areas of unmet medical needs.

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Strategies for Success in an Evolving Commercialization Landscape

PharmExec

A phased launch approach may ultimately be more sustainable and enable maximum market penetration and commercial success with less upfront investment than traditional “go-for-broke” strategies.

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Two Value-Based Care Initiatives That Could Shift the Alternative Payment Model Landscape [Sponsored]

MedCity News

The Centers for Medicare and Medicaid Services has announced two value-based care alternative payment models set to launch in July 2024, one focused on dementia and one on primary care.

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MHRA grants approval for Pfizer-BioNTech’s adapted vaccine for Covid-19

Pharmaceutical Technology

The UK MHRA has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.

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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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Bristol Myers Squibb’s Camzyos gets NICE recommendation

PharmaTimes

Therapy is used among adult patients with symptomatic obstructive hypertrophic cardiomyopathy - News - PharmaTimes

Patients 107
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Raman spectroscopy market expected to value $875m by 2028

European Pharmaceutical Review

A report published by Lucintel predicts that the global Raman spectroscopy market will value $875.2 million by 2028, with a CAGR of 7.3 percent from 2023 to 2028. Between 2023 to 2028, the research suggested that a greater focus on drug development, growing requirement for spectroscopy via cloud-based platforms, alongside the industry’s need for precise and effective analytical methods, will drive the market.

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Why this scientist left Janssen to help ‘revolutionize’ small molecule drug discovery

PharmaVoice

Murray McKinnon, CSO of Empress Therapeutics, believes its drug discovery platform holds the key to treating and detecting many diseases.

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Vitestro begins blood-drawing device study

PharmaTimes

Technology combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion - News - PharmaTimes

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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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Guidance recommending BMS cardiac myosin inhibitor published

European Pharmaceutical Review

The recommendation of Camzyos ® ▼(mavacamten) as an add-on treatment option for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults has been published in the National Institute for Health and Care Excellence (NICE)’s final guidance. Bristol Myers Squibb’s first-in-class treatment option is recommended for eligible oHCM patients on the NHS.

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AstraZeneca mulls risk strategy for Ultomiris following FDA response letter

Pharmaceutical Technology

The US FDA has requested that AstraZeneca make modifications to the Ultomiris REMS programme to approve a label expansion.

FDA 98
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HDA 2023 Traceability Seminar: A Status Update

Pharmaceutical Commerce

Stakeholders uncover the obstacles surrounding the industry onboarding process.

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New Research Reveals Perceptions of the Role of AI Among Healthcare Stakeholders

Pharma Marketing Network

“Artificial Intelligence” (AI) is certainly experiencing the shiny object spotlight in 2023. In all industries, the “what if’s” around the use of AI range from massive upsides in efficiency to looming downsides of impending elimination of entire teams. At the DHC Group, our goal to help shape the future of digital health means we focus on upcoming challenges and industry advancements, and provide insights to help prepare decision makers for the evolving digital health landscape.

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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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From Concept to Commercialization: Pushing the Envelope

PharmExec

Disruptive strategies are essential to grow the pharma industry.

Pharma 98
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New Research Reveals Perceptions of the Role of AI Among Healthcare Stakeholders

Pharma Marketing Network

“Artificial Intelligence” (AI) is certainly experiencing the shiny object spotlight in 2023. In all industries, the “what if’s” around the use of AI range from massive upsides in efficiency to looming downsides of impending elimination of entire teams. At the DHC Group, our goal to help shape the future of digital health means we focus on upcoming challenges and industry advancements, and provide insights to help prepare decision makers for the evolving digital health landscape.

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Q4: The Business World Cup and How to Score Big

Contrarian Sales Techniques

We're on the cusp of entering the most thrilling time for businesses worldwide - the fourth quarter, or as many in the business realm affectionately call it, the Q4. For those not deeply entrenched in the business world, think of this period as the Super Bowl or the World Cup. The stakes are high, the atmosphere is electric, and the playing field is rife with opportunities.

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ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility

PharmaTech

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

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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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Progressive Medical, Inc. and Asset Medical Join Forces

Progressive Medical

Delivering Innovative Infusion Therapy and Improving Patient Outcomes PMI is proud to partner with Asset Medical to offer a portfolio […] The post Progressive Medical, Inc. and Asset Medical Join Forces appeared first on Progressive Medical, Inc.

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Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes

Legacy MEDSearch

Abbott (NYSE: ABT ) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2023. Financial terms were not disclosed. Abbott and Bigfoot have worked together on connected diabetes solutions since 2017.

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The Changing Analytical Landscape

PharmaTech

The focus in labs is leaning more heavily toward automated processes while at the same time maintaining efficiency, safety, and a personalized experience for the lab worker.

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Will ‘X’ Mark the Spot for Pharma Advertisers?

PharmExec

The implications of Twitter’s rebrand for healthcare marketing.

Pharma 85
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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.