Bio Pharma Dive
AUGUST 31, 2021
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.
Pharma Mirror
SEPTEMBER 2, 2021
Frankfurt/Hyderabad, DoKaSch Temperature Solutions has opened a new service station in India. It is located at GMR Hyderabad Air Cargo terminal. Strategically, the Hyderabad Airport location is a very important network station for the global supply of lifesaving medicines given Hyderabad’s status as a major pharma production and export hub. With the new location in India, DoKaSch strengthens its network in the region and globally.
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Deltaclinical
AUGUST 31, 2021
Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, … Contact us for the right solution!
World of DTC Marketing
AUGUST 31, 2021
SUMMARY: Online health seekers are increasing in number, but so is the prevalence of inaccurate health information. Drug side effects are among the most talked about in social media, and patients are more concerned about side effects. They may not be willing to risk potential side effects like pancreatitis. DTC marketers need to reassure their audiences that drugs have been thoroughly tested and are indeed “safe and effective.” Online health seekers are not having an easy time gettin
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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
Bio Pharma Dive
AUGUST 30, 2021
Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus.
pharmaphorum
SEPTEMBER 2, 2021
An online tool used by people in Italy to manage their potential exposure to COVID-19 using a simple chat interface has shown that it can spot emerging trends days ahead of the national surveillance system. The decision support system (DSS) – developed by Italian digital health startup Paginemediche – provided a way for people to assess and interpret their symptoms and provide guidance on what to do next, such as self-isolate or seek out a test.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 29, 2021
A new variant, C.1.2. is causing public health experts worldwide to keep an eye out for its presence as it seems to be more infectious and even more resistant to vaccines than other variants.
Bio Pharma Dive
SEPTEMBER 3, 2021
A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field.
pharmaphorum
AUGUST 31, 2021
Fitness wearable company Whoop has raised another $200 million in funding that will help fund its expansion into international markets – and take on deep-pocketed rivals like Amazon, Apple and Google. The sixth-round financing was led by SoftBank’s Vision Fund 2, taking the total raised by the company to date to around $400 million, and catapults Whoop’s valuation to a massive $3.6 billion.
Deltaclinical
AUGUST 31, 2021
Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, …. Contact us for the right solution!
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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
XTalks
AUGUST 30, 2021
Desert farming has existed for thousands of years , but one center in Dubai has created desert farming equipped to handle rising temperatures and extreme weather events. While these climate change-induced factors tend to make farming difficult and disrupt food distribution, Dubai’s International Center of Biosaline Agriculture (ICBA) is creating solutions to boost local food production in the driest and hottest conditions.
Bio Pharma Dive
SEPTEMBER 1, 2021
A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them.
pharmaphorum
SEPTEMBER 1, 2021
An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers. The AI – developed by the Bristol Myers Squibb-Pfizer Alliance on cardiovascular disease – was developed using machine learning from a UK dataset of almost 3 million patients and previously found to be more effective than existing testing at identifying patients at risk of AF based on retrospective stud
Deltaclinical
AUGUST 31, 2021
Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, …. Contact us for the right solution!
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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.
NY Times
AUGUST 30, 2021
Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.
Bio Pharma Dive
SEPTEMBER 1, 2021
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
Outsourcing Pharma
AUGUST 30, 2021
A leader from the rare and infectious disease treatment specialist talks about ongoing research into a potential treatment for mild-to-moderate COVID-19.
BioSpace
AUGUST 30, 2021
?A new study on COVID-19 behavior has found that patients affected by the virus might have died due to a buildup of coronavirus directly in the lungs and not because of a secondary infection.
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.
BioPharma Reporter
SEPTEMBER 2, 2021
Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.
Bio Pharma Dive
SEPTEMBER 1, 2021
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.
NY Times
SEPTEMBER 1, 2021
The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.
BioSpace
SEPTEMBER 1, 2021
The pandemic and its subsequent effect on the workplace has been the source of stress for many professionals and executives in various industries.
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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.
Triage Cancer
SEPTEMBER 2, 2021
Breaking News: Thanks to a new decision by the U.S. Department of Education , many people with disabilities will receive automatic student loan forgiveness through the Total and Permanent Disability (TPD) Discharge program! What is a Total and Permanent Disability (TPD) Discharge? If you have a disability and are unable to work because of your medical condition, you might not have to pay off your remaining student loan balance.
Bio Pharma Dive
SEPTEMBER 3, 2021
The U.K.-based drugmaker fell behind on its promise to supply 300 million doses by the end of June to countries in the trading bloc. Now, it's set to reach that target by March 2022.
XTalks
SEPTEMBER 2, 2021
Results from a clinical validation study show that Diadem’s AlzoSure , a blood-based biomarker test, accurately predicts progression to Alzheimer’s disease (AD) up to six years prior to diagnosis. The data from the retrospective longitudinal study has been made available in a medRxiv preprint before its submission to the Journal of Neuroscience. The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood us
BioSpace
AUGUST 31, 2021
Belgium researchers compared the Moderna and Pfizer-BioNTech COVID-19 vaccines and found that the Moderna jabs generated twice the antibodies than the Pfizer-BioNTech vaccine.
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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.
BioPharma Reporter
SEPTEMBER 1, 2021
The US National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a COVID-19 vaccine booster in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.
Bio Pharma Dive
AUGUST 30, 2021
While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication.
XTalks
SEPTEMBER 1, 2021
Global medical technology leader Zimmer Biomet (NYSE and SIX: ZBH) and Canadian medical data startup Canary Medical received de novo clearance and market authorization from the US Food and Drug Administration (FDA) for a tibial extension for Persona IQ, the world’s first “smart” knee implant. The Persona IQ system is the first and only smart knee with FDA clearance for total knee replacement surgery.
pharmaphorum
SEPTEMBER 2, 2021
A US federal judge has approved a bankruptcy settlement for Purdue Pharma that grants the Sackler family that owned the business immunity from any further civil lawsuits accusing them of contributing to opioid epidemic – to the consternation of campaigners. The agreement will dissolve the OxyContin (oxycodone) manufacturer – which Judge Robert Drain said was a “bitter result” – will see around $4.5 billion being paid out by the Sackler family to projects that support victims of the o
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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.
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