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Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.
The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) and current […]
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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Presented by BetterHelp. Accessing affordable mental health services can significantly impact overall well-being. Learning how to connect with a therapist and access the kind of mental health care that you can afford can pave the way to a more satisfying and successful life. Even the WHO launched an initiative surrounding this issue in 2019. Launched in 2019, the WHO Special Initiative for Mental Health aims to ensure universal health coverage involving access to quality and affordable care for
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As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.
On today’s podcast, host Jonah Comstock welcomes Jane Reed, director of life sciences at IQVIA NLP, the new name for recent IQVIA acquisition Linguamatics. Reed talks through some of these different technologies and use cases and describes how natural language processing has exciting potential in translating real-world conversations on social media into pharmaceutical adverse event reports.
Gilead and MSD showcase once-weekly oral HIV regimen at CROI congress, as ViiV presents new data on injectable Cabenuva in patients with low adherence to daily oral therapy
GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug conjugate (ADC), given in a regimen with pomalidomide plus dexamethasone (PomDex), was shown to be more effective at preventing disease progression or death than Johnson & Johnson’s $10 billion-a-year anti-CD38 antibody Darzalex (daratumumab) with PomDex in the head-to-head DREAMM-8 trial.
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By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, discusses the biggest roadblocks to the widespread adoption of novel modalities, and how new biotech companies can navigate the current funding slowdown while securing the capital crucial for their success.
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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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