MedCity News
AUGUST 26, 2022
When pharmacies engage on a human level with patient support programs, patients become more fully engaged in their treatment, leading to potentially significant health benefits and good business for pharmacies.
Pharmaceutical Technology
AUGUST 26, 2022
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is banking on a collaborative approach to scientific innovation to address the growing problem of drug resistance in tuberculosis (TB). Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023.
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MedCity News
AUGUST 26, 2022
The healthcare industry is under constant threat from cyberattacks. By adopting the measures identified in this article, healthcare organizations can help to improve their cybersecurity and mitigate risk.
European Pharmaceutical Review
AUGUST 26, 2022
Moderna has filed patent infringement lawsuits alleging that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty ® infringes patents Moderna filed between 2010 and 2016 covering its foundational messenger RNA (mRNA) technology. The lawsuits were filed in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
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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
MedCity News
AUGUST 26, 2022
Moderna is suing Pfizer and BioNTech, claiming they copied its messenger RNA work in developing their Covid-19 vaccine. The company notes that its patented work in respiratory infectious disease began years before the start of the Covid-19 pandemic, when the biotech was pursuing an mRNA vaccine for a different coronavirus.
European Pharmaceutical Review
AUGUST 26, 2022
Substandard and falsified medicines pose a significant threat to patients and health systems globally because they cause a range of problems from being ineffective to, in the worst case, causing severe adverse reactions and avoidable deaths. While the World Health Organization (WHO) reports that one in 10 essential medicines in low- and middle-income countries (LMICs) fail quality tests, because substandard and falsified medicines are often reported together – without distinguishing what pharmac
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmaTimes
AUGUST 26, 2022
The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing
MedCity News
AUGUST 26, 2022
The future of healthcare is unfolding with interoperability and FHIR at the forefront. Access to data can lead patients and healthcare teams to make better, more informed and effective decisions about clinical care.
PharmaTimes
AUGUST 26, 2022
It is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year in the US alone
MedCity News
AUGUST 26, 2022
A federal judge blocks HHS protections for emergency abortion assistance, and a new suit is filed against Texas prosecutors who have threatened groups that help Texans travel for safe abortions.
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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.
Pharmaceutical Technology
AUGUST 26, 2022
ElevateBio has signed a long-term strategic collaboration with the University of Pittsburgh, US, to establish a biomanufacturing centre for expediting cell and gene therapy development. Under the 30-year deal, ElevateBio will set up its next BaseCamp process development and Good Manufacturing Practice (GMP) manufacturing facility in Pittsburgh. This centre will be equipped with its supporting technologies, such as gene editing induced pluripotent stem cell (iPSC) and cell, vector and protein eng
pharmaphorum
AUGUST 26, 2022
The rivalry between Moderna and Pfizer/BioNTech in commercialising their COVID-19 vaccines has now spilled over into the courts, in the form of a patent infringement lawsuit. Moderna has filed complaints in the US and Germany claiming that the mRNA technology used to make Pfizer and BioNTech’s Comirnaty vaccine infringes multiple patents that cover its own Spikevax shot.
Pharmaceutical Technology
AUGUST 26, 2022
Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. The latest development is intended to increase shareholder value by establishing a top European generics firm and a leader in biosimilars internationally. This will aid shareholders of Novartis to entirely take part in possible upside for Sandoz and Novartis Innovative Medicines businesses in the future.
Cesare Ferrari
AUGUST 26, 2022
I’m deeply convinced that it’s essential for R&D engineers and medical device customers like surgeons, nurses, and other HCPs to interact closely. If you’d like to know how I arrived at this conclusion, you’ll only need to continue reading; perhaps you too will see reasons with me. I realized that today it is almost impossible to find someone who insists that close contact between medical device users and R&D staff is unnecessary.
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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.
Pharmaceutical Technology
AUGUST 26, 2022
PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. In the initial stage, the deal will focus on key translational research in oncology, fibrosis and immunology areas to advance the work into clinical development.
pharmaphorum
AUGUST 26, 2022
Aktis Oncology has gone back for another bite of the cherry in its Series A round, adding another $84 million to the $72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round saw participation from the venture capital arm of Merck & Co plus other investors – Bristol-Myers Squibb and Novartis were already on board – and takes the total raised by the Massachusetts biotech to $161 million.
Pharmaceutical Technology
AUGUST 26, 2022
Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On August 4, the US Department of Health and Human Services (HHS) declared monkeypox a public health emergency, a move required to grant EUAs.
pharmaphorum
AUGUST 26, 2022
Merck & Co’s negotiations with Seagen over a possible takeover have stalled because the two sides cannot agree on a price, according to Bloomberg, citing people familiar with the matter. The impasse is threatening the deal, says the report , although those involved said talks could still resume and lead to an agreement. Neither Merck nor Seagen have said they will comment.
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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.
eMediWrite
AUGUST 26, 2022
The Nationwide Pharma Marketing Excellence Awards 2022 are designed to recognize individuals who have contributed to developing innovative pharmaceutical products and services that may aid in providing patients with top-notch healthcare. They honor the initiative and dedication of specific individuals who toiled in the background and oversaw advancements in general healthcare for the benefit of Indian patients.
Pharmacy Times
AUGUST 26, 2022
Additionally, approximately 70% who responded to the EnlivenHealth survey say that one-third or more of their revenue comes from individuals eligible for the government health insurance.
PharmExec
AUGUST 26, 2022
Capsulomics announces leadership appointment of industry veterans Stacey Gilbert and Lisa Kann.
Pharmacy Times
AUGUST 26, 2022
Pemigatinib is the first targeted therapy to gain FDA approval for the treatment of adult patients with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
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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.
PharmaTech
AUGUST 26, 2022
Watson-Marlow and Franz Ziel GmbH have launched a new integrated solution to fast-track cell, gene, and biological therapies.
Pharmacy Times
AUGUST 26, 2022
Yoona Kim, PharmD, PhD, co-founder and CEO of Arine, discusses some of the key takeaways from the launch of Mark Cuban's pharmacy Mark Cuban Cost Plus Drug Co.
pharmaphorum
AUGUST 26, 2022
BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe. The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII.
Pharmacy Times
AUGUST 26, 2022
The FDA has approved glycopyrrolate orally disintegrating tablets (Dartisla ODT; Edenbridge Pharmaceuticals) to reduce symptoms of peptic ulcer as an adjunct to peptic ulcer treatment in adults.
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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
pharmaphorum
AUGUST 26, 2022
A clinical trial has found that a digital care programme for people with musculoskeletal pain developed by Sword Health can improve their productivity at work, even if they also have mental health issues. Sword Health’s virtual musculoskeletal programme care programme pairs patients with a physical therapist they can talk with via telehealth, guiding them through exercises to address pain and other symptoms and also provides cognitive behavioural therapy (CBT) modules to help them develop
Pharmacy Times
AUGUST 26, 2022
Routine depression screening in the primary care setting lowered screening disparities and increased recognition of symptoms for groups at risk of undertreatment, including racial and ethnic minority individuals and patients of older age.
European Pharmaceutical Review
AUGUST 26, 2022
Scientists from the Gladstone Institutes and University of California San Francisco (UCSF) say a new variation of the CRISPR-Cas9 gene editing system enables especially long DNA sequences to be introduced to precise locations in the genomes of cells with remarkably high efficiency without the need for viral vectors. “One of our goals for many years has been to put lengthy DNA instructions into a targeted site in the genome in a way that doesn’t depend on viral vectors,” commented Alex Marson, MD
Pharmacy Times
AUGUST 26, 2022
Risk factors associated with declining health-related quality of life for adult survivors of childhood cancer, such as physical inactivity and chronic health conditions, should be targets of surveillance and intervention.
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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.
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