Pharmaceutical Technology

NOVEMBER 25, 2022

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

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pharmaphorum

NOVEMBER 25, 2022

There are approximately 7,000 different types of rare disease and researchers estimate that there are more than 300 million people worldwide living with such a condition, according to the National Institutes of Health (NIH). However, only 5% of rare diseases are estimated to have at least one approved treatment, known as “orphan” therapies. A rare disease is any disease that affects a small percentage of the population.

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Pharmaceutical Technology

NOVEMBER 25, 2022

In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022. In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.

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pharmaphorum

NOVEMBER 25, 2022

Scientists in the US say they have developed an mRNA-based vaccine that encompasses all 20 known subtypes of influenza that could form the basis of a future universal jab. While the shot is still in preclinical development, if it works in human trials it could raise the prospect of eventually sidestepping the annual scramble to guess the most likely strains to be circulating in the following flu season, and protect against future flu pandemics.

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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

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Pharmaceutical Technology

NOVEMBER 25, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy a

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pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. Hanmi reported the FDA’s rejection of the marketing application first, as the CRL emerged during the Thanksgiving holiday in the US and the Korean company wanted to eliminate “unnecessary misunderstandings” about the timing of the disclosure given the time diff

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pharmaphorum

NOVEMBER 25, 2022

In our final interview from Frontiers Health 2022, pharmaphorum Editor in Chief Jonah Comstock sits down with Paolo Borella, who runs the new VITA digital health accelerator in Italy. Paolo explains how the accelerator works, what the start-ups get, and how it benefits the various partners involved. Jonah and Paolo also talk a bit about what makes an accelerator work and why industry connections are such an important part of the accelerator equation.

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European Pharmaceutical Review

NOVEMBER 25, 2022

If approved, paliperidone palmitate extended-release injectable suspension (LY03010) is primed as a favourable option to treat schizophrenia, due to reduced dosage requirement of a once-a-month, yet it risks being hidden in a crowded long-acting injectable (LAI) market, GlobalData warns. The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ).

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pharmaphorum

NOVEMBER 25, 2022

Following an invite to fly into Parma, Italy to witness first-hand the press launch of the considerable structure – black-painted and as yet under construction, gigantic cranes and all – that is the Chiesi Group’s new Biotech Centre of Excellence, you would be forgiven for thinking this was just another laboratory and/or pharmaceutical manufacturing plant; because it quite simply isn’t.

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European Pharmaceutical Review

NOVEMBER 25, 2022

STC-15, a first-in-class ribonucleic acid (RNA) modifying enzyme inhibitor, has been dosed in the first patient in a clinical trial, making it the first molecule targeting an RNA methyltransferase to enter clinical development. Storm Therapeutics oral METTL3 inhibitor is being assessed in the Phase I study ( NCT05584111 ) to examine the drug’s effect on solid tumours.

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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.

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pharmaphorum

NOVEMBER 25, 2022

The European Commission has provided around €7 million ($7.2 million) in funding to a new project that aims to boost the ability of hospitals within the EU to collect real-world data (RWD) to gauge the effectiveness of novel cancer therapies. Dubbed ONCOVALUE, the initiative will set up a consortium that will develop an artificial intelligence (AI) platform that will be used for routine collection and analysis of clinical data on new oncology medicines to support their assessment by regulators a

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PharmaTimes

NOVEMBER 25, 2022

Research supports use of Spravato nasal spray in adults with major depressive disorder

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Spotio

NOVEMBER 25, 2022

What’s your gig? Do you drive a truck for a living? Maybe you manage a field sales team. Whatever the case may be, you need access to the best route planner software so you can get where you need to go without hassle. The problem? There are a lot of options available. In this article, we’ll discuss what routing software is, how it differs from everyday navigational apps, and the eight best tools in this category.

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PharmaTimes

NOVEMBER 25, 2022

Treatment involves adults with certain forms of advanced stomach and oesophageal cancer

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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.

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Pharmatutor

NOVEMBER 25, 2022

21 CFR PART 11 - Guidance for Industry. admin. Sat, 11/26/2022 - 12:48. This guidance is intended to describe the FDA's current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations (CFR); Electronic Records; Electronic Signatures and is in effect since August 20 1997.

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pharmaphorum

NOVEMBER 25, 2022

The latest market study report from the Competition Bureau has provided recommendations to health care providers (HCPs) on how to improve the ways they work within Canada’s public health system. ‘Empowering health care providers in the digital era’ is the Competition Bureau’s third and final report published as part of its digital health care market study , which examines how pro-competitive policies can foster innovation and bring about greater choice and access to digital health care services

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Quantified

NOVEMBER 25, 2022

As organizations shift to create more dynamic structures and resources for their business’s revenue teams, more emphasis on effective sales enablement is reaching every corner of the sales process. Nowhere is this more crucial than sales training. New BDRs and salespeople need engaging, supportive training to learn the ropes; experienced salespeople want to sharpen their skills to grow their commissions.

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pharmaphorum

NOVEMBER 25, 2022

German pharma Grünenthal has started the process of taking ownership of 13 ageing medicines developed by Japan’s Kyowa Kirin, which are currently sold by affiliate companies across Europe. The first stage of the rights transfer is the formation of a joint venture between the two companies – 51% owned by Grünenthal – that will have rights to the brands, which have annual revenues of around €200 million ($207 million) a year.

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Safety

Pharmaceutical Technology

NOVEMBER 25, 2022

The global pharmaceutical industry experienced a 2% drop in new job postings related to environmental sustainability in Q3 2022 compared with the previous quarter, according to GlobalData’s Jobs Analytics. This compares to a 2% increase in the previous quarter and a 22% increase versus Q3 2021. Notably, Building Cleaning Workers jobs accounted for a 9% share of the global pharmaceutical industry’s environmental sustainability-related total new job postings in Q3 2022, up 1% over the

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Pharmacy Times

NOVEMBER 25, 2022

Pharmacists play a significant role in the comprehensive management of this condition through education, intervention, and monitoring.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The global pharmaceutical industry experienced a 30% rise in new job postings related to cybersecurity in Q3 2022 compared with the previous quarter, according to GlobalData’s Jobs Analytics. This compares to a 30% increase in the previous quarter and a 70% increase versus Q3 2021. Notably, Registered Nurses jobs accounted for a 9% share of the global pharmaceutical industry’s cybersecurity-related total new job postings in Q3 2022, up 1315% over the prior quarter.

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Pharmacy Times

NOVEMBER 25, 2022

Leveraging pharmacogenomic testing, simultaneous multidrug analysis can help prevent drug interactions affecting pain management.

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Management 55

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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 Technology

NOVEMBER 25, 2022

The global pharmaceutical industry experienced an 8% drop in new job postings related to cloud in Q3 2022 compared with the previous quarter, according to GlobalData’s Jobs Analytics. This compares to an 8% increase in the previous quarter and a 21% increase versus Q3 2021. Notably, Software and Web Developers, Programmers, and Testers jobs accounted for a 19% share of the global pharmaceutical industry’s cloud -related total new job postings in Q3 2022, down 17% over the prior quart

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Pharmacy Times

NOVEMBER 25, 2022

This issue's OTC Cases answer common questions about a cough.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The global pharmaceutical industry experienced a 7% drop in new job postings related to artificial intelligence in Q3 2022 compared with the previous quarter, according to GlobalData’s Jobs Analytics. This compares to a 7% increase in the previous quarter and a 63% increase versus Q3 2021. Notably, General and Operations Managers jobs accounted for an 11% share of the global pharmaceutical industry’s artificial intelligence-related total new job postings in Q3 2022, up 12% over the p

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European Pharmaceutical Review

NOVEMBER 25, 2022

According to Future Market Insights’ most recent report , the global automated cell biology systems market stands at $14.1 billion in 2022 and is anticipated to be worth around $33.5 billion in 2032, due to rising demand for personalised medicine and increased total lab automation techniques. The research showed lab automation, made possible by new technologies and applications, have become a major focus in the biotechnology sector over the last two decades.

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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

Pharmaceutical Technology

NOVEMBER 25, 2022

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop paediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and sustaining revenue growth through paediatr

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Pharmaceutical Technology

NOVEMBER 25, 2022

All evidence indicated that containment in facilities is in high demand and will be increasingly so in the future as the oncology pipeline and the use of cytotoxic drugs continues to grow. For pharmaceutical manufacturers and contract manufacturing organizations (CMOs) with containment capabilities, this likely means a distinct advantage over those without.

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