Bio Pharma Dive
JUNE 7, 2021
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.
World of DTC Marketing
JUNE 6, 2021
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost? The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware.
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Camargo
JUNE 9, 2021
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone a light on both the creativity and the broad range of specialized capabilities needed for such complex development programs.
BioSpace
JUNE 9, 2021
An immunocompromised patient in South Africa became a veritable COVID-19 variant laboratory as the virus mutated more than 30 times in 216 days of her infection, according to recent, not-yet-peer-reviewed research paper published in medRxiv.
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 10, 2021
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next.
World of DTC Marketing
JUNE 8, 2021
SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 10, 2021
Three Gold Standards awarded for partnership work in patient advocacy and communications
Bio Pharma Dive
JUNE 9, 2021
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.
World of DTC Marketing
JUNE 5, 2021
SUMMARY: Obesity has many causes, and while we would like to think the answer is as easy as people exercising more and eating less, it isn’t that simple. There is disagreement whether obesity is really considered a disease or a behavioral risk factor, similar to smoking, alcohol, and substance abuse that may lead to disease. Obesity is a multifactorial disease in which environmental conditions and several genes play an important role in developing this disease.
pharmaphorum
JUNE 9, 2021
“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.
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
Pharma Times
JUNE 11, 2021
New guidance enables earlier access to certain treatments, including biologics
Bio Pharma Dive
JUNE 11, 2021
The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.
World of DTC Marketing
JUNE 11, 2021
Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. Out of nearly 450 U.S. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased. Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now wit
pharmaphorum
JUNE 11, 2021
A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.
Pharma Times
JUNE 9, 2021
The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease
Bio Pharma Dive
JUNE 10, 2021
The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.
World of DTC Marketing
JUNE 10, 2021
SUMMARY: Several online providers promise that they can reach physicians with your message, but I would argue that numbers are only important if they can be measured against key brand objectives. Ask your target audience what THEY use and how they use it to understand each platform’s relevance. According to research from HealthLink Dimensions, more than a third of physicians reported using social networks to communicate with their professional peers, and 59% said they see the value in s
Pharma Mirror
JUNE 11, 2021
In the new normal scenario of Healthcare, where the approaches are patient-centric and no longer product-centric, traditional and integrative medicinal practices are rooting to the greater extent so does the ‘Ethno-pharmacy’ At the intersection of social and natural sciences, Ethno-pharmacy is a field that focuses on the traditional medicines (and pharmaceuticals) and the cultural determinants to investigate the possible use/perception of traditional medicines (and also pharmaceutica
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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
Pharma Times
JUNE 9, 2021
Under Operation Pangea, officers were also able to shut down or block 113,000 illegally operating websites
Bio Pharma Dive
JUNE 8, 2021
Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face.
BioSpace
JUNE 9, 2021
David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
Pharma Mirror
JUNE 6, 2021
Terrassa (Barcelona): Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production and integrated turnkey engineering & construction services for process facilities at Achema Pulse 2021. The company will be present at the digital flagship event of the global process industries during the whole of June and will be live during 15-16th June.
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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.
Pharma Times
JUNE 7, 2021
Conditional marketing authorisation granted for the treatment of recurrent or advanced endometrial cancer
Bio Pharma Dive
JUNE 9, 2021
Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.
BioPharma Reporter
JUNE 7, 2021
The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
Pharma Mirror
JUNE 6, 2021
Emergency medical response requires a coordinated effort. It’s a field that burdens people with the task of providing an organized and immediate medical response in an often chaotic and high-pressure environment. To be able to do this in a consistent and timely manner, many emergency medical services (EMS) providers rely on electronic patient care reports (ePCR) solutions. ePCR is critical to the operation of EMS organizations because it allows staff members and response coordinators to stay on
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.
Pharma Times
JUNE 9, 2021
The NIHR-supported RECOVERY trial found that the anti-inflammatory drug does not improve survival for hospitalised patients with COVID-19
Bio Pharma Dive
JUNE 7, 2021
Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine.
BioSpace
JUNE 7, 2021
The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?
Pharma Mirror
JUNE 5, 2021
Ashfield Engage, part of UDG Healthcare plc, today announced that it has been selected by US-based Pacira BioSciences, Inc. to provide strategic commercialization services for its non-opioid pain management products in select European countries. Pacira has partnered with Ashfield Engage to develop a commercial strategy and deliver outsourced operations in numerous European countries, including the UK, Germany, Sweden, Austria, Netherlands and Finland.
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