Thu.Jul 18, 2024

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Pfizer's ATTR heart disease drug needs hefty discount, says ICER draft report. What about Alnylam's Amvuttra?

Fierce Pharma

Pfizer’s blockbuster drug tafamidis for the treatment of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) needs at least a 96% discount off its list price to be considered cost | Pfizer’s blockbuster tafamidis for the treatment of the rare heart disease ATTR-CM needs at least a 96% discount off its list price to be considered cost-effective under common benchmarks, a draft report by ICER has found.

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The FTC Released a Scathing Interim Report on PBMs. What’s Next?

MedCity News

The Federal Trade Commission recently released an interim report that details how the practices of pharmacy benefit managers negatively impact patients and pharmacies. Some experts hope for legislative action based on the report. The post The FTC Released a Scathing Interim Report on PBMs. What’s Next? appeared first on MedCity News.

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Novartis CEO sees IRA impact ‘manageable’ in short run, maintains midterm growth goal

Fierce Pharma

As biopharma companies and the U.S. | As biopharma companies and the U.S. government near the deadline of their drug price talks under the Inflation Reduction Act, Novartis CEO said the cost cuts “might be manageable” in the short term for the firm’s first few products to be included.

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What the Medicare Quality Rating Change Means for Healthcare Companies — and Patient Health

MedCity News

SMS is reevaluating its Star Ratings. Not only do health plans stand to benefit from the new calculations — all healthcare companies and millions of patients will reap the rewards. The post What the Medicare Quality Rating Change Means for Healthcare Companies — and Patient Health appeared first on MedCity News.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Roche shows durability of eye disease treatments Vabysmo, Susvimo

Fierce Pharma

After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo | After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo.

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PBMs will face House committee grilling next week

pharmaphorum

The House Committee on Oversight and Accountability will quiz leaders of pharmacy benefit managers (PBMs) at a hearing next week, amid scrutiny of the sector's role in rising healthcare costs in the US.The hearing – scheduled for 23rd July – is part of an ongoing investigation by the committee into PBMs' alleged anticompetitive practices launched last year and spearheaded by chairman James Comer (R-Ky).

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Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

MedCity News

Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). Phathom licensed its flagship product from Takeda Pharmaceutical. The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News.

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Argenx posts J&J-rivaling Sjögren's data, massively upscales Vyvgart patient population at R&D day

Fierce Pharma

Even as argenx begins to chart a course toward a future beyond Vyvgart, the company’s flagship FcRn inhibitor still has plenty of tricks in store for the remainder of the decade. | Even as argenx begins to chart a course toward a future beyond Vyvgart, the company’s flagship FcRn inhibitor still has plenty of tricks in store for the remainder of the decade.

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Specialty Pharmacy: A Sound Strategy to Weather Hospital Financial Storms, Enhance Patient Care

MedCity News

In addition to increasing medication access for underserved populations, an in-house specialty pharmacy improves patient care and provides opportunities for efficiency and enhancement across hospital operations. The post Specialty Pharmacy: A Sound Strategy to Weather Hospital Financial Storms, Enhance Patient Care appeared first on MedCity News.

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Aveo spins a silver lining in failed trial of kidney cancer drug Fotivda

Fierce Pharma

The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death in kidney cancer patients who had tried an im | The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death compared with Fotivda alone in kidney cancer patients who had tried an immune checkpoint inhibitor.

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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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What Intermountain Health Hopes to Achieve with its New Behavioral Health Partnership

MedCity News

The Salt Lake City health system will pilot NeuroFlow’s behavioral health tech platform and services in five primary care locations in Colorado. The first step is to integrate technology into its Epic EHR but the broader goal is to create the mechanism by which behavioral healthcare can be standardized and measured. The post What Intermountain Health Hopes to Achieve with its New Behavioral Health Partnership appeared first on MedCity News.

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Paratek looks to bolster pneumonia antibiotic Nuzyra with win in post-marketing study

Fierce Pharma

After its buyout last summer by Novo Holdings and Gurnet Point, Paratek Pharmaceuticals reaffirmed the benefits of its Biomedical Advanced Research and Development Authority (BARDA)-backed Nuzyra w | After its buyout last summer by Novo Holdings and Gurnet Point, Paratek Pharmaceuticals reaffirmed the benefits of its BARDA-backed Nuzyra with a positive post-marketing study.

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J&J IRA pricing offer is in, as it sticks with 2025 guidance

pharmaphorum

J&J has three of its top-selling drugs in Medicare pricing negotiations but does not expect a major hit to its finances next year

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FDA launches new rare disease innovation hub

Pharmaceutical Technology

The new hub will act as a central point of connection and engagement for the rare disease community for FDA-related concerns.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Supplemental Benefits are Worth Fighting for to Support Senior Health

MedCity News

The new CMS guidelines represent a transformative moment for Medicare Advantage — here are three ways to be good stewards of taxpayer dollars and create a healthier future for seniors The post Supplemental Benefits are Worth Fighting for to Support Senior Health appeared first on MedCity News.

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Boehringer backs Brainomix AI software for lung fibrosis

pharmaphorum

Boehringer Ingelheim has joined forces with digital health firm Brainomix on a project to improve the care of people with fibrosing lung diseases

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Johnson & Johnson’s Q2 2024 net earnings drop 12.8% to $4.6bn

Pharmaceutical Technology

Johnson & Johnson has reported a 12.8% decrease in net earnings for Q2 2024, with figures falling to $4.6bn from $5.3bn in Q2 2023.

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Re-elected von der Leyen pledges EU measures for biotech

pharmaphorum

Ursula von der Leyen highlights biotech and AI as key sectors in speech as she is re-elected as President of the European Commission

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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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Gilead eyes ‘ending the HIV epidemic’ via incremental progress

PharmaVoice

With a long elusive HIV cure ever on the horizon, Gilead’s latest long-acting PrEP study shows that every step counts.

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Cystic fibrosis drug improves outcomes in severe COVID-19 pneumonia

PharmaTimes

Genentech’s Pulmozyme could also treat other respiratory infections and conditions

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Merdad Parsey will leave Gilead next year

pharmaphorum

Gilead Sciences' chief medical officer Merdad Parsey has said he will leave the company in early 2025

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Study reveals new AI tool predicts recurrence of prostate cancer by a decade

PharmaTimes

The most commonly diagnosed cancer in men in the UK leads to over 12,000 annual deaths

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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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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. They are also increasingly the focus of R&D across the world and remain a modality that is regularly the focus of deals across the industry. 1 As they can be highly targeted in their action, they could become the treatment of choice for clinicians and patients due to the reduc

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Tips for on-time tech transfers that stay on budget

pharmaphorum

Discover valuable tips for ensuring on-time tech transfers within budget in this podcast featuring industry experts Frantz Maignan, Grant Brock from Lannett CDMO.

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Inside Canary Wharf’s infectious disease testing facility

Pharmaceutical Technology

hVIVO specialises in human challenge trials for influenza and RSV therapeutic candidates.

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CCC Takes a Big Step in Helping to License Copyrighted Materials in AI Systems

Copyright Clearance Center

CCC introduced artificial intelligence (AI) re-use rights within its Annual Copyright Licenses (ACL), an enterprise-wide content licensing solution offering rights from millions of works to businesses that subscribe.

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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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CMS Proposes New Reimbursement for Advanced Primary Care Management Services

Nixon Gwilt Law

The New Advanced Primary Care Management HCPCS Codes Under the Proposed Rule, physicians and non-physician practitioners – for example, nurse practitioners (NPs) and physician assistants (PAs) – can order and bill for APCM services. Notably, CMS specifically states that the practitioner who bills for APCM services intends to be responsible for the patient’s primary care and is the continuing focal point for all needed health care services.

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Progressive Medical, Inc. Welcomes EdgeX to our Family of Products

Progressive Medical

EdgeX is a GAMECHANGER PMI is happy to announce a partnership with EdgeX, Inc. to to introduce its EdgeX […] The post Progressive Medical, Inc. Welcomes EdgeX to our Family of Products appeared first on Progressive Medical, Inc.

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Sentiments Surrounding At-Home Diagnostic Testing

Pharmaceutical Commerce

In an interview with Pharma Commerce editor Nicholas Saraceno, Matthew Walsh, ixlayer’s manager of biopharma, discusses findings of a new physician survey that the company conducted.

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UK needs RNA workforce “fit for the future”

European Pharmaceutical Review

A report produced by the Centre for Process Innovation (CPI), alongside CDMO FUJIFILM Diosynth Biotechnologies, has acknowledged “significant” gaps in the UK skills and workforce for RNA therapeutics. The future workforce could require “at least 150 future capabilities to meet RNA vaccine and treatment demand”, according to the report. To support the manufacturing of RNA medicines, these capabilities include development of new equipment and reagents to increase efficiencies, the report

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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.