Fierce Pharma

APRIL 11, 2024

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

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Biopharma Pharma 326

Dominic Tyer

APRIL 11, 2024

Online changes pose some pressing questions for the industry and demand a new approach to websites and data

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Pharma Pharmaceutical Marketing 130

Fierce Pharma

APRIL 11, 2024

The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea. | The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea.

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Government 302

MedCity News

APRIL 11, 2024

Grow Therapy’s $88 million Series C funding round was led by Sequoia Capital. The financing will help the company invest in its team, improve its product and expand its footprint. The post Grow Therapy Secures $88M To Expand Mental Health Services appeared first on MedCity News.

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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

Distribution

Fierce Pharma

APRIL 11, 2024

After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., told lawmakers that the agency, as the "referee," needs to be given more authority in order to preemptively halt drug shortages.

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FDA 293

MedCity News

APRIL 11, 2024

Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant. The post Novartis Pays $150M to Nab a Phase 3-Ready Protein Degrader for Prostate Cancer appeared first on MedCity News.

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Biopharma Pharma 123

MedCity News

APRIL 11, 2024

Following an extensive investigative report from the New York Times, the AHA is calling for the Labor Department to probe into the business practices of data analytics firm MultiPlan. The report revealed that MultiPlan works with major payers to negotiate reduced reimbursements for out-of-network medical providers — and this that practice ends up costing patients and employers.

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Networking Medical Patients 120

Fierce Pharma

APRIL 11, 2024

As the contract manufacturing industry stands at a crossroads, certain CDMOs are prospering while other stalwarts are going the sell-off route or warding off political and economic threats to their | Fujifilm Diosynth is investing $1.2 billion more to soup up its end-to-end biomanufacturing facility in Holly Springs, North Carolina, bringing the total project to more than $3.2 billion, the company said Thursday.

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Manufacturing 242

PharmaTech

APRIL 11, 2024

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

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FDA 116

Fierce Pharma

APRIL 11, 2024

Geopolitical tensions are casting uncertainties over cross-border biotech deals. | Geopolitical tensions are casting uncertainties over cross-border biotech deals. Johnson & Johnson and Legend Biotech's Carvykti, plus AstraZeneca and Daiichi Sankyo's Enhertu, secured new FDA approvals. Fujifilm is making a big investment in its facility in North Carolina.

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Pharma FDA 179

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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.

Safety

MedCity News

APRIL 11, 2024

As the healthcare evolves toward service-based models, providers increasingly look to balance service delivery demands while keeping their core medical values without yielding to an overburdened system’s pressures. The post A Guide for Specialty Practices Navigating a Future of Healthcare that Does Good and Feels Good appeared first on MedCity News.

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Healthcare Healthcare Medical 111

European Pharmaceutical Review

APRIL 11, 2024

Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, [which has] resulted in increased competition and price pressure, driving the growth of the biosimilar market” A report published by Towards Healthcare has estimated that the global biosimilar market will value $1,26,019.67 million by 2032, at 17.6 percent CAGR between 2023 and 2032.

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Marketing Competition Manufacturing Healthcare Provider 102

pharmaphorum

APRIL 11, 2024

The European Parliament has voted through reforms to legislation regulating the pharma sector, which the industry claims could compromise competitiveness and patient care.

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Pharma Competition Patients 94

European Pharmaceutical Review

APRIL 11, 2024

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. 1 That’s more than the automotive sector, which released 46.4 megatonnes in the same year, and the increased demand and complexity of medicines since then will only have swollen this figure. 1 Every major pharmaceutical manufact

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Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 102

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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.

Specialization

pharmaphorum

APRIL 11, 2024

Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.

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FDA 110

PharmaTimes

APRIL 11, 2024

RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR

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Prescription Medical 116

Pharmaceutical Technology

APRIL 11, 2024

The oral drug, which gained UK approval in September 2023, is used for the prevention of both chronic and episodic migraines.

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pharmaphorum

APRIL 11, 2024

Novartis accelerates its protein degrader programmes by licensing a phase 3-ready prostate cancer candidate from Arvinas in a deal worth over $1 billion

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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.

Safety

PharmaTimes

APRIL 11, 2024

Prostate cancer is responsible for around 12,000 deaths a year in the UK and is the second biggest cause of death for men

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Leads 92

pharmaphorum

APRIL 11, 2024

AbbVie’s Aquipta has become the first oral therapy for chronic and episodic migraine prevention to be recommended by NICE for NHS use.

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PharmaTech

APRIL 11, 2024

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews Dr. Krizia M. Karry, Global Head of Technical Marketing for BASF Pharma Solutions, on the topic of hot melt extrusion.

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Pharma Pharmaceutical Marketing 69

pharmaphorum

APRIL 11, 2024

US files a lawsuit against Regeneron, accusing the pharma company of fraudulent price reporting for ophthalmology drug Eylea

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Pharma 87

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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.

Management

Pharmaceutical Commerce

APRIL 11, 2024

Companies striving for transformed and targeted growth are exploring strategies that include partnerships, artificial intelligence, increased efficiencies, and competitive intelligence.

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Pharma Competition 59

MedCity News

APRIL 11, 2024

Share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health, healthcare navigation, and more. The post Health Benefit Consultants, Share Your Expert Insights in Our Survey appeared first on MedCity News.

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Consulting Healthcare Healthcare 56

Pharmaceutical Commerce

APRIL 11, 2024

The latest news for pharma industry insiders.

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Pharma Medicine 104

European Pharmaceutical Review

APRIL 11, 2024

A current good manufacturing practice (cGMP) oligonucleotide manufacturing facility is set to be built Berlin. Planned under a new strategic partnership between Asahi Kasei Bioprocess (AKB) and contract research development & manufacturing organisation (CRDMO) Axolabs , it will help to accelerate oligonucleotide therapeutics development globally.

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Manufacturing Sales Management Pharmaceutical 52

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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

Leads

Copyright Clearance Center

APRIL 11, 2024

April 11, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced the election of international intellectual property and artificial intelligence (AI) law expert Dr. Daniel J. Gervais to its Board of Directors. Gervais currently serves as the Milton R. Underwood Chair in Law at Vanderbilt University Law School , where he is also director of the Vanderbilt Intellectual Property Program and co-director of the Master of L

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Government Consulting Education Leads 52

PharmaTech

APRIL 11, 2024

Charles River has entered into separate agreements with Axovia Therapeutics and Ship of Theseus to offer plasmid DNA manufacturing services for a gene therapy and a lead candidate program, respectively.

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Manufacturing Leads 52

Pharmaceutical Commerce

APRIL 11, 2024

A cohort study digs into whether there is an improvement in overall survival or quality of life within five years of the FDA granting accelerated approval to oncology drugs.

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FDA 52

PharmExec

APRIL 11, 2024

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses how a personalized approach in obesity treatment can benefit access.

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Pharmaceutical 52

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients