Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
World of DTC Marketing
JUNE 15, 2021
QUICK POINTS: Telemedicine claims as a proportion of all commercial health insurance claims decreased by 5.1% nationwide from February to March, after a steeper decline of 15.7% from January to February as vaccination efforts increased and COVID-19 increased. Cases declined as a result. Telehealth claims accounted for 7% of all medical claims positions in January, before falling to 5.9% in February and 5.6% in March, suggesting a steady slowdown in virtual care demand this year.
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Pharma Times
JUNE 15, 2021
New real world data from PHE shows vaccines can protect against hospitalisation caused by variant
pharmaphorum
JUNE 16, 2021
Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
JUNE 18, 2021
The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.
World of DTC Marketing
JUNE 18, 2021
SKIMMERS SUMMARY: According to a GAO Report “Medicare Parts B and D and beneficiaries spent $560 billion on drugs from 2016 through 2018, $324 billion of which was spent on advertised drug” GAO’s review of four advertised drugs found that drug manufacturers changed their DTCA spending during key events, such as increasing spending when a drug was approved to treat additional conditions or decreasing spending following the approval of generic versions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 15, 2021
NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.
Bio Pharma Dive
JUNE 14, 2021
Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.
World of DTC Marketing
JUNE 17, 2021
SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.
Pharma Times
JUNE 18, 2021
Axial spondyloarthritis affects approximately one in 200 people in the UK
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
Camargo
JUNE 15, 2021
Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background. The sponsor’s product used a novel delivery platform technology designed to reduce the treatment burden for people with a rare chronic pituitary gland disorder.
Bio Pharma Dive
JUNE 18, 2021
Compared to vaccines, development of antiviral drugs for the coronavirus has progressed more slowly, although data are expected soon from Merck, Pfizer and Atea.
Pharma Mirror
JUNE 12, 2021
As growing strain on pharmaceutical technology necessitates more efficient practice, Alfa Laval has launched the CultureOne™, the industry’s first premium separator system for single-use cell culture processing. According to Bioplan Associates, single-use bioprocessing technologies now dominate the pre-commercial manufacturing space. However, Alfa Laval states many companies have not been able to make the transition to ‘full-single-use’ when harvesting proteins due to the lack of a single-use di
Pharma Times
JUNE 16, 2021
New antibody tests can detect if an individual has been exposed to COVID-19 variants, including Alpha and Delta variants
BioSpace
JUNE 18, 2021
The data showed that both experimental therapies restored function in the cystic fibrosis transmembrane conductance regulator gene.
Bio Pharma Dive
JUNE 16, 2021
The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.
pharmaphorum
JUNE 15, 2021
The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients infected with delta (B.1.617.2, formerly known as the Indian variant), with no deaths recorded, according to AZ.
Pharma Times
JUNE 16, 2021
The primary endpoint of the study is a 50% reduction in monthly migraine headache days
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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
BioSpace
JUNE 13, 2021
Retinal tissue has been regrown in three patients with age-related macular degeneration with geographic atrophy or dry (atrophic) AMD in a Phase I/IIa study conducted by Lineage Cell Therapeutics.
Bio Pharma Dive
JUNE 16, 2021
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
pharmaphorum
JUNE 14, 2021
Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment of patients with malignant glioma, an aggressive form of brain cancer that affects around 2,500 people in Japan.
Pharma Times
JUNE 18, 2021
NHSX and Accelerated Access Collaborative (AAC) have backed 38 AI-driven research projects
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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.
BioPharma Reporter
JUNE 15, 2021
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
Bio Pharma Dive
JUNE 17, 2021
Capitalizing on investor interest in gene editing, the high-profile startup has secured one of the richest biotech initial public offerings priced this year.
pharmaphorum
JUNE 17, 2021
While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.
Pharma Times
JUNE 18, 2021
Xeljanz reduced the incidence of death or respiratory failure compared to placebo in hospitalised patients
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
NY Times
JUNE 17, 2021
A new $3.2 billion program will support the development of antiviral pills, which could start arriving by the end of this year.
Bio Pharma Dive
JUNE 15, 2021
Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.
pharmaphorum
JUNE 16, 2021
As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.
Pharma Times
JUNE 17, 2021
Company attributed 47% vaccine efficacy to ‘unprecedented’ amount of circulating variants
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