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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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Policy Innovation Is Outpacing Technology at the Intersection of Health Care and Human Services

MedCity News

Profound opportunities and challenges are playing out at the intersection of the two. The post Policy Innovation Is Outpacing Technology at the Intersection of Health Care and Human Services appeared first on MedCity News.

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CCC Pioneers Collective Licensing Solution for Content Usage in Internal AI Systems

Copyright Clearance Center

July 16, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced the availability of artificial intelligence (AI) re-use rights within its Annual Copyright License s (ACL), an enterprise-wide content licensing solution offering rights from millions of works to businesses that subscribe.

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

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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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Endo Recalls Clonazepam Because of Mislabeling

PharmaTech

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

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CCC Launches Collective Licensing for AI

Copyright Clearance Center

Copyright Clearance Center has launched a collective licensing solution for the internal use of copyrighted materials in artificial intelligence systems, with the aim of providing streamlined, legal means to use content and compensate creators.

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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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FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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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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CCC Announces a Collective Licensing Subscription for AI Systems

Copyright Clearance Center

Copyright Clearance Center's AI re-use rights offer stands in its Annual Copyright Licenses subscription program for 'millions of works.

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Report: Cost Reduction Is Less of a Priority for Health CFOs Compared to Past Years

MedCity News

Cost reduction is no longer a top priority for healthcare finance leaders, a new Deloitte survey found. In past years, cost reduction was among the top three priorities. The post Report: Cost Reduction Is Less of a Priority for Health CFOs Compared to Past Years appeared first on MedCity News.

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Vertex, Orum partner on safer pre-treatment for gene meds

pharmaphorum

Vertex Pharma has teamed up with Orum Therapeutics to develop a conditioning regimen, used to prepare patients to receive gene-editing medicines, that it hopes will offer a more tolerable alternative to current chemotherapy options.Vertex is paying $15 million upfront to get the ball rolling on the collaboration, which could be worth up to $945 million if it exercises options to use the technology for three developmental programmes and all of them hit various milestones.

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Has pharma emerged from the ‘age of uncertainty’?

PharmaVoice

An industry reeling from a precarious market is showing signs of stabilizing as the future becomes a little less cloudy, an Evaluate report suggests.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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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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AstraZeneca’s Tagrisso gains approval in Canada for NSCLC

Pharmaceutical Technology

AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.

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Digital Health’s Funding Rebound Is Going Well, Market Research Shows

MedCity News

The digital health fundraising market seems to be truly normalizing following the highs and lows of the pandemic, according to market research. During the first half of this year, U.S. digital health startups raked in $5.7 billion across 266 deals. The post Digital Health’s Funding Rebound Is Going Well, Market Research Shows appeared first on MedCity News.

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Ozempic’s latest health benefit may be cutting dementia risk

pharmaphorum

Observational study finds lower risk of cognitive problems and nicotine dependence in diabetics using Novo Nordisk's Ozempic

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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J&J, BMS and AstraZeneca strike back in appeals after IRA litigation losses

Fierce Pharma

Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act. | Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act.

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AstraZeneca completes Amolyt Pharma acquisition

Pharmaceutical Technology

AstraZeneca has closed the acquisition of Amolyt Pharma, a company specialising in treatments for rare endocrine diseases.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo leads $100m financing for Alzheimer's player Asceneuron

pharmaphorum

Novo Holdings leads $100m financing for Swiss biotech Asceneuron, which is developing an oral tau therapy for Alzheimer's disease

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Treating Rheumatoid Arthritis Patients With Biosimilars Versus Leflunomide: An Economic Evaluation

Pharmaceutical Commerce

A study explores the cost-effectiveness of combining methotrexate with various drugs as a way to combat failed methotrexate monotherapy.

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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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The US Biosecure Act threatens to destabilise the pharmaceutical industry 

Pharmaceutical Technology

In January, the US House Select Committee on the Strategic Competition between the US and the Chinese Communist Party introduced the Biosecure Act.

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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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Traditional Member Engagement is Broken. Daily Care Motivation is the Only Way to Improve Outcomes

MedCity News

It’s time to hold ourselves to a higher standard. Our industry needs to reimagine what can be accomplished in member engagement by more effectively incorporating behavioral science principles and personalization into our solutions, just as leaders in other industries have done. The post Traditional Member Engagement is Broken. Daily Care Motivation is the Only Way to Improve Outcomes appeared first on MedCity News.

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GLP-1 bonanza spurs big investment at CDMO CordenPharma

pharmaphorum

CordenPharma has launched a €900 million ($981 million) investment programme to prepare for an expected surge in demand for peptide production capacity – driven by GLP-1 receptor agonists.The three-year plan revolves around parallel programmes in the US and Europe that will include new builds and upgrades and expansion to its existing facilities, according to the German contract development and manufacturing organisation (CDMO).

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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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J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer

Fierce Pharma

CAR-T specialist Legend Biotech has reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser to evaluate its options, StreetInsider

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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.