Trending Articles

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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.

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AI in Pharma: Navigating New Frontiers in Drug Discovery and Development

Pharma IQ

Bringing a new drug to market typically takes a decade or more and approximately US$2.5 billion. However, new technology, including AI, can dramatically shorten the drug discovery process and reduce t.

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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.

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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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Dentistry’s Technological Revolution Is Transforming Patient Trust

MedCity News

The way dentistry has embraced technological innovation to make patient care both safer and more comfortable serves as an example for the rest of the healthcare sector.

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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

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More Trending

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CHMP backs AZ’s danicopan for anaemia in patients with PNH

pharmaphorum

AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).

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‘Nation-State’ Cyberattack Hits Change Healthcare, Disrupting Pharmacy Services Across the Country

MedCity News

Pharmacies across the country are facing disruptions following a cyberattack on Change Healthcare — which is owned by Optum, a subsidiary of UnitedHealth Group. In a filing with the SEC, UnitedHealth stated that the unauthorized party that gained access to Change Healthcare’s systems was a “suspected nation-state associated cyber security threat actor.

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Small Press Values

Copyright Clearance Center

SPD takes risks on books by new or marginalized writers, enabling their works to develop an audience and to gain recognition, says Kent Watson.

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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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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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For Moderna, COVID vaccines were a ‘proof of concept’ — now comes the big test

PharmaVoice

Following Moderna’s COVID-19 vaccine success, therapeutics head Dr. Kyle Holen discusses scaling mRNA development to bring candidates to the finish line in oncology and more.

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FDA starts review of Argenx drug in rare disease CIDP

pharmaphorum

The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).

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At ViVE 2024, Panelists Share Prior Authorization Progress and Frustration in Payer Insights Program [Sponsored]

MedCity News

At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.

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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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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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After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

Fierce Pharma

As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new owner in the U.S. | As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new U.S. owner in Rigel Pharmaceuticals.

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Value and potential of IoT and AI for chronic diseases treatment

PharmaVoice

A significant growth is predicted for both AI and IoT in healthcare. By 2030, the AI market is expected to reach $187.95 billion USD, while the IoT market is projected to climb even higher to $312.7 billion USD.

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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.

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What to Expect from Your Language Services Provider during CMS Test Call Season

MedCity News

Performance on these test calls impacts the organization’s Star Rating, which is a marker of plan quality published on the Medicare Pathfinder. A lower rating can mean the loss of millions of dollars in reimbursements.

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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 Accepts Biologics License Application for Datopotamab Deruxtecan

Pharmaceutical Commerce

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

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Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.

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Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study

Pharmaceutical Technology

US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.

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Pfizer’s ulcerative colitis drug Velsipity gets EU okay

pharmaphorum

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

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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.

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Meet the Marketplace Providers Are Using to Overcome the ‘Notorious Challenge’ of Radiology AI Adoption

MedCity News

About 80% of all FDA-approved healthcare AI applications are related to radiology — but due to a massive workforce shortage, radiologists don’t have the time to explore, choose, validate and implement the tools available to them. Some providers are using a radiology AI marketplace called CARPL to address this problem, including Massachusetts General Hospital and University Hospitals.

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Analyzing PCSK9 Inhibitor Use in Adults With Cardiovascular Disease

Pharmaceutical Commerce

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

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Sanofi CEO Hudson takes another small dip in pay to €10.57M

Fierce Pharma

For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. | For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. For 2023, Hudson will receive 10.57 million euros ($11.44 million) in total pay, according to the company’s annual filing.

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SK bioscience’s typhoid vaccine receives WHO prequalification

Pharmaceutical Technology

SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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AI improves adenoma detection in colonoscopies

pharmaphorum

AI software developed by Israeli medtech Magentiq-Eye has been shown to improve detection rates for adenoma, a precursor to colorectal cancer, in colonoscopy procedures

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When It Comes to Egg Donation, the Ethical Option is Choice for All

MedCity News

Providers have an ethical imperative to facilitate a truly informed choice for parents and donors, which means educating them about the facts around anonymous donation, the potential needs of their donor-conceived child, and the importance of choosing programs that dedicate time and effort toward obtaining updated medical information.

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Identifying Trends Surrounding the Use of In-House Pharmacies for High-Cost Drugs

Pharmaceutical Commerce

A cross-sectional study investigates how this supply chain link helps increase Medicare Part D spending on self-administered specialty drugs.

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BeiGene grows global workforce by 1,000+ as Brukinsa surges, Tevimbra launches outside China

Fierce Pharma

The chilling wind of the biotech winter has apparently spared BeiGene. | The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.