Mon.Nov 20, 2023

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After protests, pharma industry reaches 'landmark' drug spending deal with UK government

Fierce Pharma

After blasting the U.K.’s drug pricing policy, the pharma industry has secured a new government spending deal featuring a higher revenue cap and an innovative drug-friendly rebate mechanism. | After blasting the U.K.’s drug pricing policy, the pharma industry has secured an improved government spending deal. The agreement will double the annual growth rate for prescription meds over the coming years.

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The Disconnect between R&D Costs and High Drug Prices

MedCity News

Multiple studies have shown no correlation between R&D costs and the launch price of new drugs though that is an argument often used by drugmakers to prevent a cap on pricing. Still, one way to keep costs low, is for organizations to leverage health technology like AI and improve formulary compliance.

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Using AI to Become Pharma's Next Superhero

Fierce Pharma

“AI is becoming part of the pharma fabric, and it really is set to disrupt the industry.” | Viz.ai’s Nina Binetti is joined by colleagues at CrowdPharm and Remedy Product Studio to explore the various ways in which AI is being used among pharma companies – from improving patient diagnoses and treatments to unlocking operating efficiencies.

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Surviving and Thriving in the Age of AI: How Healthcare Leaders Can Learn What They Need to Know

MedCity News

AI may transform health care across the board, but not by itself. It’s a tool, and like any tool, it will work more effectively and more safely in trained hands. As the AI revolution continues to grow, we believe organizations should invest in that training now.

Training 124
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA pushes back decision date on BMS, 2seventy bio's Abecma in earlier line of treatment

Fierce Pharma

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. | It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting.

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What One Medicaid Insurer Looks for From Potential Health Tech Vendors

MedCity News

Many digital health startups aren’t built with Medicaid members in mind. That’s why Health Net created a request for information process to help the insurer determine which startups are the best fit for its Medicaid population, according to Dr. Pooja Mittal, vice president and chief health equity officer at Health Net.

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More Trending

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How Digital Health Can Support Suicide Prevention Among Adolescents

MedCity News

Engaging parents in their kids’ mental health treatment can improve health outcomes. With digital health, it’s easier to do this, according to one mental health executive.

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FDA approves Pfizer spinout SpringWorks' Ogsiveo as first treatment for disfiguring rare tumor type

Fierce Pharma

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. | Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

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5 Questions Providers Must Ask to Ensure More Equitable AI Deployment

MedCity News

Experts agree there are some concrete steps healthcare providers can take to ensure AI will be integrated more smoothly and equitably. Some of these measures include ensuring that models are trained on diverse datasets, keeping clinicians in the loop and prioritizing patient consent.

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Teva granted pretrial appeal in high-stakes Copaxone kickbacks case

Fierce Pharma

Teva’s latest play in its yearslong defense against kickback claims levied by the U.S. government has secured the company a slight legal reprieve. | With the high-stakes trial now on pause, the U.S. First Circuit Court of Appeals will review a prior ruling that determines how the case can play out.

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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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Phone Attachment for Pupil Measurements with Any Skin Tone

Medgadget

A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those with a dark iris, which is more common in people with darker skin tones, because it can be challenging to distinguish between the iris and the pupil.

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Bayer Falls Short in Bid to Beat Eliquis in Afib, But Key Stroke Study Continues

MedCity News

An independent data monitoring committee concluded Bayer’s experimental drug for atrial fibrillation would not be more effective than Eliquis, a blockbuster product currently used for the indication. Consequently, Bayer decided to stop that Phase 3 test for the once-daily oral small molecule.

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Biohaven wants to muscle in on the Ozempic craze with a competing class of drugs

PharmaVoice

Biohaven and other companies are aiming to develop meds with a different mechanism of action that trim the waistline while building lean tissue.

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Enhancing Dementia Care and Empowering Caregivers with GUIDE

MedCity News

GUIDE — Guiding an Improved Dementia Experience — is the new dementia care model from the CMS and the CMMI (Centers for Medicare and Medicaid Innovation) for beneficiaries covered by traditional fee-for-service (FFS) Medicare and their caregivers. It represents an incremental step forward in managing neurodegenerative diseases effectively.

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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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Stretchable E-Skin for Robotic Prostheses

Medgadget

Engineers at the University of British Columbia have collaborated with the Japanese automotive company Honda to develop an e-skin for robotic prostheses that allows such devices to sense their environment in significant detail. The soft skin is highly sensitive, letting robotic hands to perform tasks that require a significant degree of dexterity and tactile feedback, such as grasping an egg or lifting a glass of water without breaking it.

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Takeda wins EU approval for paediatric use of Takhzyro in HAE

Pharmaceutical Technology

Takhzyro has been approved for the routine prevention of recurrent hereditary angioedema attacks in patients aged 2 years and older.

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Carmot’s IPO Filing Makes Case for Bias in Drugging Key Obesity, Diabetes Targets

MedCity News

Carmot Therapeutics isn’t the first company targeting both the GLP-1 and GIP receptors to treat metabolic diseases. But the company contends that biased signaling—activating certain pathways but not others—is key to setting its drugs apart from others in the same class.

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Are haemophilia gene therapies truly “one and done”?

Pharmaceutical Technology

The value of haemophilia gene therapies like Roctavian and Hemgenix hinge on long-term efficacy and innovative payment structures play a key role.

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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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Eli Lilly reveals plans for new high-tech parenteral manufacturing site

European Pharmaceutical Review

Eli Lilly and Company has announced that it plans to construct a new $2.5 billion parenteral (injectable) manufacturing site in Alzey, Rhineland-Palatinate, Germany. Supporting European parenteral manufacture and supply Alongside expanding the company’s global parenteral product and device manufacturing network, the new facility will support the higher demand for Eli Lilly’s medicines, including its diabetes and obesity portfolio.

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After FDA no, Almirall’s eczema drug gets EU okay

pharmaphorum

The European Commission has approved Almirall’s lebrikizumab as Ebglyss for the treatment of moderate-to-severe atopic dermatitis (AD), with an EU rollout set to start in Germany next year.

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AstraZeneca launches new digital health solutions business Evinova 

Pharmaceutical Technology

AstraZeneca has launched a new digital health solutions business, Evinova, to expedite innovation in the life sciences industry.

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What We’re Watching for 2024 – Top Trends in Market Access

Eversana Intouch

In the rapidly changing landscape of global markets, staying ahead of the curve is crucial for businesses aiming to expand and thrive. As we step into 2024, the realm of market access undergoes dynamic shifts influenced by technological advancements, policy changes, and evolving consumer behaviors. There are the usual suspects like evolving provider models, the continued transition to value-based care and pharma/biotech companies increased investment in “access,” but there are two trends that ar

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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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BHF and UKDRI announce first UK centre for vascular dementia research

PharmaTimes

The centre will help discover new treatments to prevent, halt and cure the condition - News - PharmaTimes

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EU pharma legislation key in tackling AMR

European Pharmaceutical Review

On World Antibiotic Awareness Week (WAAW), 18-24 November 2023, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the importance of efficient legislation for determining the EU’s future actions in the challenge to overcome antimicrobial resistance (AMR). The trade association for Europe’s pharmaceutical industry urged in a statement that in facing the threat of AMR, a “comprehensive approach, encompassing enhanced surveillance, prudent use, preventive

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NHS expands COVID-19 research platform for other major diseases

PharmaTimes

The OpenSAFELY platform will support the discovery of new treatments - News - PharmaTimes

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Coaching Publishers

Copyright Clearance Center

“A good coach can change a game,” said UCLA’s John Wooden. “A great coach can change a life.

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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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The Outsource Decision: Key Considerations When Optimizing Trademark Renewal Operations

Clarivate

For trademark portfolios with hundreds or thousands of marks registered in jurisdictions around the world, keeping up with renewals is a complex task with significant risk potential. Missing a renewal deadline can be catastrophic. This mistake can potentially lead to the loss of trademark rights in one or more jurisdictions or classes. Even in the best case, it may require re-registration—a costly, time-consuming process.

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Bayer pulls atrial fibrillation study for asundexian

pharmaphorum

Bayer pulls atrial fibrillation study for asundexian Phil.

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Selling To Distributors: 9 Steps For Success In 2024

Spotio

There are many different ways to sell the products you manufacture. You can, for example, sell directly to end consumers via your website and in-person meetings. Or to retail outlets like Walmart, The Home Depot, and Best Buy. Or both. But what if you don’t have the desire or technical know-how to build a full-fledged direct-to-consumer (D2C) business?

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Do physician incentives work to change behavior patterns?

Clarify Health

Physician incentive programs have been around for decades. However, the question remains: Are they actually effective at changing provider behavior? Incentive programs have the potential to significantly influence physician behavior for the better, but their effectiveness hinges on the design and implementation of the program. Factors such as the type of incentive, clarity of performance metrics and measurement, and frequency of feedback play a crucial role in determining their ability to influ

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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.