Thu.Nov 23, 2023

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HHS Proposes Rule to Bolster Prohibitions Against Discrimination on the Basis of a Disability in HHS Programs

MedCity News

With proposed requirements ranging from accessible self-service kiosks to accessible medical equipment, the impact of this new rule will be wide-ranging with financial, operational, and practical consequences.

Medical 126
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Moderna completes next stage of UK R&D facility build

pharmaphorum

US biotech Moderna has completed the installation of its clinical laboratories at its new R&D facility in the UK dedicated to the discovery of new mRNA vaccines and therapeutics, part of a 10-year partnership with the government agreed last year that has been estimated to be worth around £1 billion.

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PBMs Are in Regulators’ Crosshairs But Are Regulators Missing the Point?

MedCity News

Proposals targeting misaligned financial incentives, price transparency, and pharmacy access are important and necessary reforms. But the consequences of failing to address pharmacy benefit managers’ use of market power to block competition and extract monopoly profits from payers and consumers will not be limited to drug costs – it will change all of healthcare for generations.

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Oligonucleotide manufacturing centre to open in Scotland

European Pharmaceutical Review

Following the UK government’s recent announcement of a £520 million funding boost for UK manufacturing, a new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland will develop innovative and sustainable techniques for these medicines. According to the Centre for Process Innovation (CPI), oligonucleotides therapeutics use short, chemically synthesised fragments of DNA or RNA to modulate protein expression and ultimately treat the underlying cause of disease.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Boehringer Ingelheim acquires T3 Pharma for $509m

Pharmaceutical Technology

T3 Pharma uses a bacterial secretion system for the delivery of immune-modulating proteins to cancer cells and tumour micro-environments.

Pharma 96
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Genentech and NVIDIA enter into strategic AI research collaboration

PharmaTimes

Both companies will use their platforms to accelerate drug discovery and development - News - PharmaTimes

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Digitalisation and PAT: current landscape and future trends

European Pharmaceutical Review

Last month at CPHI Barcelona 2023 , EPR interviewed Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training ( NIBRT ). During the conversation, Noor shed light on how digitalisation is impacting the biopharmaceutical industry. Additionally, he explored the trends, challenges and opportunities for process analytical technology (PAT).

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UK “keeping up momentum” on clinical trials review

pharmaphorum

Lord James O’Shaughnessy has welcomed the UK government’s official response to his review of commercial clinical trials, saying there have been a number of positive developments since it was published in the spring.

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Trends in Virtual Collaboration

Impetus Digital

A version of this article was previously published in the Journal of mHealth. With the end of the year quickly approaching, you will likely see multiple articles on the key trends of 2023 and predictions for 2024 start popping up. Many of these will discuss the expanding role and capabilities of AI and machine learning in the Pharma space. Others might talk about the return of in-person meetings after the COVID-19 pandemic.

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Best practices for AI and ML use across the drug discovery and development lifecycle

Clarivate

As AI becomes part of the fabric of our personal and professional lives, its use continues to reveal both its potential and limitations. The speed and accuracy of drug discovery and development are being transformed by AI and machine learning (ML) applications. AI and life science companies alike need to conduct due diligence to ensure optimal results and avoid the pitfalls of poor data sources and an over-reliance on technology’s capabilities.

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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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Novo Nordisk will invest €2.1bn in French manufacturing site

pharmaphorum

Novo Nordisk will invest €2.1bn in French manufacturing site Phil.

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EirGenix and Sandoz win EU approval for Herceptin biosimilar

Pharmaceutical Technology

EirGenix and Sandoz's biosimilar has been approved for all the indications as the reference biologic, Roche’s Herceptin.

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InDex craters on phase 3 ulcerative colitis failure

pharmaphorum

InDex craters on phase 3 ulcerative colitis failure Phil.

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SK bioscience and Hilleman to develop Ebola-Zaire virus vaccine

Pharmaceutical Technology

SK bioscience has signed an agreement with Hilleman Laboratories Singapore for the co-development of a vaccine against the Zaire Ebola virus.

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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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Centering Sustainability and Environmental Impact in the Supply Chain

PharmaTech

Chris Spivey, editorial director for Pharmaceutical Technology and Biopharm International, spoke with Concetto Andrea Rizza, Marketing and Communications manager, ICE Pharma, on sustainability and ICE’s green approach at CPhI Barcelona 2023.

Pharma 52
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FDA fast tracks Alladapt’s multi-food allergy immunotherapy

Pharmaceutical Technology

The fast track designation for the paediatric multi-food allergy therapy ADP101 was based on the Phase I/II data.

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Hovione Expands Technology Platforms with ExtremoChem Acquisition

PharmaTech

Hovione has acquired start-up company, ExtremoChem, expanding its technology platforms.

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China’s NMPA accepts NDA for AnHeart and Innovent’s lung cancer therapy

Pharmaceutical Technology

China’s NMPA has accepted NDA for AnHeart Therapeutics taletrectinib to treat locally advanced or metastatic ROS1-positive NSCLC.

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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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Industry Responds to the UK’s Autumn Statement

PharmaTech

UK industry body, ABPI, has responded positively to the recent Autumn Statement.

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The benefits of using an app to manage gestational diabetes: Niki’s story

Pharmaceutical Technology

When expectant mothers are diagnosed with gestational diabetes mellitus (GDM) they often feel anxious and need extra support.

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Children Remain High Risk for Antiphospholipid Syndrome

Pharmacy Times

Pediatric individuals that are higher risk for APS must be followed to better understand affects

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Simcere and Connect sign licensing agreement for anti IL-4R? AD drug  

Pharmaceutical Technology

Simcere will have the rights to develop and commercialise rademikibart in mainland China, Macau, Taiwan, and Hong Kong.

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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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Boehringer Ingelheim to advance bacterial cancer therapeutics

European Pharmaceutical Review

Boehringer Ingelheim is acquiring Swiss biotech T3 Pharmaceuticals AG (T3 Pharma), for up to £406 million (450 million CHF), boosting its immuno-oncology portfolio. The pharmaceutical company will utilise T3 Pharmaceutical’s proprietary bacterial cancer therapy platform that consisting that delivers immune-modulating bioactive proteins to cancer cells and tumour micro-environments.

Pharma 106
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Syncona to acquire biotechnology company Freeline Therapeutics

Pharmaceutical Technology

Syncona has signed a definitive agreement to acquire clinical-stage biotechnology company Freeline Therapeutics

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Alladapt’s allergy treatment receives FDA fast track designation

PharmaTimes

ADP101 is an oral immunotherapy to treat multi-food and single-food allergies - News - PharmaTimes

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Vivodyne raises funding for lab-grown human organs

Pharmaceutical Technology

Biotech company Vivodyne has raised $38m in total seed financing for the development of lab-grown human organs.

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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