Bio Pharma Dive
MAY 4, 2022
Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.
World of DTC Marketing
MAY 4, 2022
A 2015 Commonwealth Fund brie f showed that — before the major provisions of the Affordable Care Act were introduced — the United States had worse outcomes and spent more on health care, primarily because of greater use of medical technology and higher prices, compared to other high-income countries. The United States ranks last overall, despite spending far more of its gross domestic product on health care.
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Bio Pharma Dive
MAY 4, 2022
Though executives claimed that inking deals and derisking research programs are priorities, analysts questioned whether any meaningful strategic changes will occur in the near term.
pharmaphorum
MAY 4, 2022
Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves discovers how the technology could provide more accurate safety predictions and even discover new treatments. The limits of animal models in drug discovery are well known.
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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
MAY 4, 2022
The trajectory of COVID-19 vaccine sales is now harder to predict amid questions about the rollout of additional doses and whether purchasing in the U.S. might shift from the federal government to private payers.
BioPharma Reporter
MAY 4, 2022
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 4, 2022
Cognitive problems affecting memory and attention can be substantial and long-lasting in patients who suffer severe COVID-19 infections, according to a study by researchers in the UK. The study used computerised cognitive assessments to follow-up 46 people who were hospitalised with COVID-19 at the Addenbrooke’s Hospital in Cambridge over a three-month period in 2020, comparing the results with 460 matched control subjects.
XTalks
MAY 4, 2022
Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 mg, 5 mg, 10 mg and 15 mg capsules of Camzyos for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.
BioPharma Reporter
MAY 4, 2022
CPhI North America 2022 host city Philadelphia is set to become one of the worldâs biggest cell and gene therapy manufacturing hubs. But itâs just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
XTalks
MAY 4, 2022
Pathotrak, a Maryland-based startup that aims to increase the speed of food safety testing, reached a milestone with the certification of its test sample preparation process. Last month, the company received AOAC Performance Tested certification for its foodborne pathogen enrichment kits. So, how does Pathrotrak detect foodborne illnesses-causing pathogens?
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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
MAY 4, 2022
COLUMBIA, Mo. – As an eighth-grade science teacher in Missouri, Jeannie Sneller knows firsthand it can be challenging for some middle school students to have the stamina and reading comprehension skills needed to make sense of the complex texts, tables, charts and graphs required to understand eighth-grade science, engineering and mathematics topics.
BioPharma Reporter
MAY 4, 2022
âOpen scienceâ encourages the public sharing of research data, helping researchers tackle biological threats. And yet, as the biotech industry moves forward in leaps and bounds, the risk of accidental or deliberate misuse of biological research increases. Researchers from the University of Oxford call for greater attention to ensure these two areas are properly balanced.
Scienmag
MAY 4, 2022
New Orleans, LA, May 5, 2022—Significant imaging findings (cancer, infection, pseudoaneurysm, fracture, bowel perforation) can occur in emergency department (ED) patients undergoing imaging, an award-winning Electronic Exhibit noted this morning during the 2022 ARRS Annual Meeting in New Orleans, LA. Credit: American Roentgen Ray Society New Orleans, LA, May 5, 2022—Significant imaging findings (cancer, infection, […].
Pharma Times
MAY 4, 2022
Platform will enable patients to monitor and share updates of their post-surgical wound healing
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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
MAY 4, 2022
(Boston)— Overwhelming evidence shows that infection with severe acute respiratory syndrome (SARS-CoV-2) causes dysfunction of multiple organ systems, including the nervous system. Neurologic symptoms are frequently reported even in patients with mild illness and for some, these neurologic symptoms may persist as part of long-haul COVID. To describe the prevalence, associated risk factors and outcomes […].
Pharma Times
MAY 4, 2022
Approval for Kymriah follows a positive CHMP opinion and is applicable to all 27 EU member states
Scienmag
MAY 4, 2022
A team led by University of Minnesota Twin Cities researchers has revealed, for the first time, that landslides can have a major impact on the movement of glaciers. Using satellite imagery to study the effects of a 2019 landslide that occurred on the Amalia Glacier in the Patagonia region of Chile, the researchers found that […].
pharmaphorum
MAY 4, 2022
Hello Heart has raised $70 million in fourth-round financing to help grow its smartphone-based technology for people seeking to improve their heart health. Hello Heart blood pressure monitor. Hello Heart’s digital platform is based on a blood pressure monitor and smartphone app. It deploys artificial intelligence to help users track their blood pressure, pulse rate, weight and activity levels – as well as any medications taken – and give feedback and advice on how to adopt healthy practice
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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
MAY 4, 2022
LA JOLLA, CA—Getting sick with a common cold doesn’t make you immune to COVID-19, but a COVID-19 infection might, at least temporarily, boost the number of antibodies you have against common cold-causing coronaviruses and the SARS-CoV-1 and MERS-CoV viruses, all of which are closely related. Scientists at Scripps Research have now characterized coronavirus antibodies isolated […].
Antidote
MAY 4, 2022
Antidote’s podcast, Talk of the Towne , focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an organization with which Antidote is working, and takes an in-depth look at particular therapeutic areas, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.
Scienmag
MAY 4, 2022
PITTSBURGH, May 4, 2022 – Neurobiologists at the University of Pittsburgh School of Medicine give new meaning to the term “motor mouth” in a study published today in the Proceedings of the National Academy of Sciences. By carefully mapping neural networks in marmoset and macaque monkeys, they determined that multiple areas in the brain’s frontal […].
XTalks
MAY 4, 2022
In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. The editorial team discussed the significant unmet need for this condition and how although many women’s health issues are now given greater spotlight, there still need to be more conversations
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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
MAY 4, 2022
The UK is the last major Western economy not to legislate ‘Powered Micro Vehicles’. The University of Warwick wants to change that and has proposed a new set of regulations for allowing micromobility vehicles, such as e-scooters to operate legally in the UK. The report looks at ways to improve the quality and safety of […].
Cloudbyz
MAY 4, 2022
NAPERVILLE, Ill. , May 4, 2022 /PRNewswire/– Cloudbyz , a fast-growing integrated clinical research and development solution provider with integrated capabilities, today announced that it has partnered with Tech Mahindra to provide integrated Clinical Trial Management Solutions. Tech Mahindra is a leading provider of digital transformation, consulting, and business re-engineering services and solutions.
Scienmag
MAY 4, 2022
The biotech industry is constantly searching for the perfect mutation, where properties from different proteins are synthetically combined to achieve a desired effect. It may be necessary to develop new medicaments or enzymes that prolong the shelf-life of yogurt, break down plastics in the wild, or make washing powder effective at low water temperature.
pharmaphorum
MAY 4, 2022
SAE Media Group’s 3rd Annual Conference. Pre-Filled Syringes San Francisco. September 19 – 20, 2022 | San Francisco, CA, USA. ————————————————————————-. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, a
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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.
Scienmag
MAY 4, 2022
Plant colonisation by biotrophic pathogens requires sophisticated strategies for tissue invasion, defence suppression and metabolic manipulation to loot nutrients necessary for their growth and reproduction. The biotrophic fungus Ustilago maydis secretes a multifaceted effectome during maize plant colonisation to achieve the abovementioned tasks. Effectors are microbial secreted manipulative molecules that act outside or inside the […].
pharmaphorum
MAY 4, 2022
Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ rival Yescarta. Follicular lymphoma is the second most common form of non-Hodgkin lymphoma (NHL), and is a slow developing but incurable disease that represents around 22% of NHL cases.
Scienmag
MAY 4, 2022
DETROIT (May 4, 2022) – Henry Ford Medical Center – Brownstown has earned an Acute Stroke Ready Hospital advanced stroke certification from The Joint Commission, making it the first freestanding Emergency Room in the State of Michigan to do so, and Henry Ford Macomb Hospital has earned recertification as a Primary Stroke Center. The Joint Commission is an independent, not-for-profit organization that […].
pharmaphorum
MAY 4, 2022
The FDA has kicked off a priority review of AstraZeneca’s checkpoint inhibitor Imfinzi for biliary tract cancer (BTC), setting up what could be approval for an immunotherapy for the group of rare and aggressive gastrointestinal tumours. The six-month review means that PD-L1 inhibitor Imfinzi (durvalumab) could get a verdict from the US regulator in the third quarter of the year.
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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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