Bio Pharma Dive
MARCH 25, 2022
The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.
pharmaphorum
MARCH 25, 2022
Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. Fitbit is already approved by the FDA to provide electrocardiogram (ECG) monitoring of heart rhythms, and in 2020 its Sense Smartwatch was cleared by the regulator to use the ECG functionality to detect AFib – although that requires active input from the user.
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Pharma Times
MARCH 25, 2022
The site in Kent will support the manufacture of regulatory approved cannabis-based medicines while also leveraging environmental practices
pharmaphorum
MARCH 25, 2022
In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without digging further, one might think the current case for digital therapeutics is weak.
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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
Intouch Solutions
MARCH 25, 2022
Two years into the pandemic and some of us, while enjoying and appreciating the opportunity to work safely at home, have been itching to get back into the office and see each other … to do the things we used to do. There were cake days and happy hours and meeting up in the office kitchens to just take a minute — to be friends and catch up on each others’ lives — agency life is fast and furious, so breaks and fun are a must sometimes.
pharmaphorum
MARCH 25, 2022
The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for their Cabenuva product that does away with the need for an oral lead-in period. The label update means that people living with HIV who want to trade their daily oral doses of antiretroviral therapy (ART) for an injection delivered once a month or every two months will no long need to transition to oral therapy with the active ingredients in Cabenuva
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 25, 2022
AstraZeneca’s hopes of developing its PD-L1 inhibitor Imfinzi for cervical cancer have been hit by a failed phase 3 trial of the drug alongside chemotherapy as a first-line treatment for women with locally-advanced tumours. The CALLA trial compared Imfinzi (durvalumab) with chemoradiotherapy (CRT) to CRT alone in an all-comer cervical cancer population – regardless of PD-L1 biomarker status – hoping to extend the use of immunotherapy in this type of cancer.
BioPharma Reporter
MARCH 25, 2022
Exothera, a CDMO specializing in the industrialization of vaccine and gene therapy processes, reports that it has achieved GMP certification for its facilities in Jumet, Belgium.
XTalks
MARCH 25, 2022
Pfizer has issued voluntary recalls for several lots of its blood pressure medication Accuretic, and two generic versions of it, over concerns of higher than acceptable levels of a nitrosamine called N-nitroso-quinapril, which is associated with an increased risk of cancer. The affected medications include six lots of Accuretic tablets and batches of two authorized generics of the drug distributed by Greenstone that include one lot of quinapril and hydrochlorothiazide tablets and four lots of qu
Pharma Times
MARCH 25, 2022
STP1 has demonstrated good safety and tolerability profiles, while also showing positive results for neurological function
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Scienmag
MARCH 25, 2022
Embargoed press materials are now available for the Experimental Biology (EB) 2022 meeting, featuring cutting-edge research from across the life sciences. EB 2022, to be held April 2–5 in Philadelphia, is the annual meeting of five scientific societies bringing together thousands of scientists and 25 guest societies in one interdisciplinary community.
Outsourcing Pharma
MARCH 25, 2022
The Pancreatic Cancer Action Network has engaged five new clinical trial sites in the US, which will aid in evaluation of Novartisâ investigational therapy.
Scienmag
MARCH 25, 2022
PHILADELPHIA – The American Association for Cancer Research (AACR) announced today that John E. Dick, PhD, Fellow of the AACR Academy, will receive the inaugural AACR Award for Outstanding Achievement in Blood Cancer Research. The AACR established this award to recognize an individual for meritorious achievements and contributions to basic, translational, or clinical research related […].
NY Times
MARCH 25, 2022
A drug to prevent preterm birth may provide the next test of the agency’s process for speedily getting drugs on the market, despite limited evidence that some work.
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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.
Scienmag
MARCH 25, 2022
March 25, 2022 – Fabio Demontis, Ph.D., will present the latest research on the topic Myokine-based interventions to contrast muscle and brain aging at the worlds’ largest annual Aging Research and Drug Discovery conference (9th ARDD). Dr. Fabio Demontis is the Associate Member and Principal Investigator at St. Jude Children’s Research Hospital, USA.
Drug Channels
MARCH 25, 2022
Today’s guest post comes from Ian Ocilka, Senior VP of Client Solutions at ConnectiveRx. Ian explains some of the challenges associated with negotiating the medical benefit for both patients and providers. He goes on to describe the need for combining technology solutions and meaningful human connection for improved patient outcomes. To learn more, join experts from ConnectiveRx on April 26th at 1 pm ET for a free, online panel discussion: The Evolving Medical Benefits Landscape—Are you Ready fo
Scienmag
MARCH 25, 2022
Scientists at Nanyang Technological University, Singapore (NTU Singapore) have developed probiotics with a unique edible coating that ensures the beneficial bacteria successfully reach the intestine once they are ingested. Credit: NTU Singapore Scientists at Nanyang Technological University, Singapore (NTU Singapore) have developed probiotics with a unique edible coating that ensures the beneficial bacteria successfully reach […].
ECRG Media's Clinical Research Podcast
MARCH 25, 2022
Clinical Research Q&A Part 2 Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or
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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.
Scienmag
MARCH 25, 2022
An obscure species of wild grass contains “blockbuster” disease resistance that can be cross bred into wheat to give immunity against one of the deadliest crop pathogens. Credit: Pablo Olivera Firpo An obscure species of wild grass contains “blockbuster” disease resistance that can be cross bred into wheat to give immunity against one of the […].
ECRG Media's Clinical Research Podcast
MARCH 25, 2022
Clinical Research Q&A Part 2. Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.
Scienmag
MARCH 25, 2022
GPS tracking of Caspian terns showed that male parents carry the main responsibility for leading young during their first migration from the Baltic Sea to Africa. Credit: Petri Hirva GPS tracking of Caspian terns showed that male parents carry the main responsibility for leading young during their first migration from the Baltic Sea to Africa. […].
Drug Discovery World podcast
MARCH 25, 2022
This is the latest episode of the free DDW podcast, “ Scientific data management: What does your lab need? ”. It covers three narrated articles written for Volume 22, Issue 3 – Summer 2021 and Volume 22, Issue 4 – Fall 2021 of DDW. . The articles are called “The benefits of bioinformatics in genomics sequencing” and “LIMs vs ELNs – what does your lab need?
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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.
Scienmag
MARCH 25, 2022
The Bank of Okinawa has announced that Genome Miner and Menopause and Beyond, two startups participating in the Innovation Square Startup Accelerator Program at the Okinawa Institute of Science and Technology (OIST), will each receive a ¥1 million grant to support their entrepreneurial journey. The grant award is a key result of a Memorandum of […].
Drug Patent Watch
MARCH 25, 2022
Annual Drug Patent Expirations for FINTEPLA Fintepla is a drug marketed by Zogenix Inc and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Zogenix Inc drug FINTEPLA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 25, 2022
NEW YORK, NY (March 25, 2022) – A study published today in Nature Communications unveils a new platform for discovering cellular signatures of disease that integrates robotic systems for studying patient cells with artificial intelligence methods for image analysis. Using their automated cell culture platform, scientists at the NYSCF Research Institute collaborated with Google Research […].
Drug Patent Watch
MARCH 25, 2022
Annual Drug Patent Expirations for QINLOCK Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent for Deciphera Pharms drug QINLOCK appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
MARCH 25, 2022
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg. People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.
Drug Patent Watch
MARCH 25, 2022
Annual Drug Patent Expirations for RECORLEV Recorlev is a drug marketed by Strongbridge and is included in one NDA. There are five patents protecting this drug. This drug has twenty-seven…. The post New patent for Strongbridge drug RECORLEV appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MARCH 25, 2022
Maximizing potential of traditional medicines through modern science and technology. The World Health Organization (WHO) and the Government of India today signed an agreement to establish the WHO Global Centre for Traditional Medicine. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from the Government of India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the heal
Scienmag
MARCH 25, 2022
An orally absorbed tablet containing cannabidiol (CBD) effectively reduces pain after shoulder surgery with no safety concerns, a new study finds. Led by researchers in the Department of Orthopedic Surgery at NYU Langone Health, the study found that the tablet ORAVEXXTM safely managed pain after minimally invasive rotator cuff surgery, and did not produce […].
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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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