Sat.Jul 13, 2024 - Fri.Jul 19, 2024

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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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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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

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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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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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Susvimo Demonstrates Sustained Efficacy Over Two Years in Patients with Diabetic Macular Edema and Diabetic Retinopathy

Pharmaceutical Commerce

FDA to review one-year results for Susvimo showing non-inferior visual acuity gains in diabetic macular edema and in the Diabetic Retinopathy Severity Scale for Diabetic Retinopathy.

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The Shifting AI Landscape

MedCity News

A new eBook from MedCity News highlights the variety of technologies emerging from AI tech developers across the healthcare landscape from health tech startups to healthcare organizations, biopharma companies, and a medtech giant. It also explores the ethical issues AI in healthcare presents. The post The Shifting AI Landscape appeared first on MedCity News.

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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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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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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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European Pharmacopoeia makes milestone pyrogen testing commitment

European Pharmaceutical Review

European Pharmacopoeia has confirmed it will remove the rabbit pyrogen test (RPT) from its monographs. This milestone decision was made during the Ph. Eur.’s 179th session in June 2024. The RPT has been the traditional detection method for pyrogens, the European Directorate for the Quality Of Medicines (EDQM) explained. In June 2021, the European Pharmacopoeia Commission (EPC) committed to completely replace the RPT in the 59 Ph.

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Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

MedCity News

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. The post Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial appeared first on MedCity News.

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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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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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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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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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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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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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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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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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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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What Does It Take to Move an Entire Hospital in 1 Day? Intermountain Health Is About to Find Out

MedCity News

For the past two years, Intermountain Health has been planning to move its hospital in the Denver suburb of Wheat Ridge, Colorado about three and a half miles away to a new and updated facility. The health system is planning to complete the move in one day, using about 20 ambulances to move an estimated 180 patients. The post What Does It Take to Move an Entire Hospital in 1 Day?

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GSK moves back to its roots with new central London headquarters

Fierce Pharma

After two decades headquartered in the West London suburb of Brentford, GSK is officially coming home to central London. | After two decades headquartered in the West London suburb of Brentford, GSK's new digs are officially open and will house 3,000 workers in London's Knowledge Quarter.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype

Fierce Pharma

Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC). | Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer.

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Cardurion heads crop of sizeable bio financings

pharmaphorum

While the pace of biotech private rounds seems to have slowed a little of late, this week saw four big financings for Cardurion Pharma, Scorpion Therapeutics, CatalYm, and NGM Bio.Burlington, Massachusetts-based Cardurion led the quartet with a $260 million Series B for its heart-focused drug pipeline, which features two candidates in phase 2 testing – PDE9 inhibitor CRD-750 for heart failure and CaMKII inhibitor CRD-4730 for rare genetic disease catecholaminergic polymorphic ventricular tachyca

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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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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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Roche Weighs In With Encouraging Early Clinical Data for Oral GLP-1 Drug

MedCity News

Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. The post Roche Weighs In With Encouraging Early Clinical Data for Oral GLP-1 Drug appeared first on MedCity News.

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Johnson & Johnson proposes $505M settlement with bankrupt talc miners

Fierce Pharma

As Johnson & Johnson continues to attempt to Texas two-step its way around thousands of claims that its popular talcum powder-based products caused cancer, the drugmaker is putting up hundreds | As Johnson & Johson continues to attempt to Texas two-step its way around thousands of claims that its popular talcum powder-based products caused cancer, the drugmaker is putting up hundreds of millions of dollars to settle a longstanding dispute with a clutch of suppliers.

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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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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.