Bio Pharma Dive
SEPTEMBER 12, 2022
Scientists at Pretzel believe fixing mutated mitochondrial DNA with a mix of small molecule therapies and gene editing could be key to solving a number of hard-to-treat diseases.
Pharmaceutical Technology
SEPTEMBER 12, 2022
The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy. It should not be used along with other immunosuppressants.
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Bio Pharma Dive
SEPTEMBER 12, 2022
The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline.
World of DTC Marketing
SEPTEMBER 12, 2022
Apple’s Health app gets new capabilities with iOS 16. The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. Will it matter? The health app will also tell users about potential interactions between medications, and it’s possible to connect with healthcare providers to see a list of past medications, get future updates, or add items to your schedule.
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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
SEPTEMBER 12, 2022
Results from the company’s Phase 3 study show Lumakras outperformed chemotherapy. But that effect didn’t translate into patients living longer.
Pharmaceutical Technology
SEPTEMBER 12, 2022
Health Canada has granted authorisation for Pfizer ’s unit Pfizer Canada and BioNTech’s Covid-19 vaccine, Comirnaty, as a three 3?g initial regimen for usage in children aged six months to under five years. This dosage was chosen as the preferred dose in children aged under five years based on safety, tolerability and immunogenicity findings. The latest development is based on the findings from the randomised, controlled Phase II/III trial that enrolled 4,526 children of this age group.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
SEPTEMBER 12, 2022
Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.
Bio Pharma Dive
SEPTEMBER 12, 2022
The money will help fund development of a TYK2 inhibitor that Nimbus CEO Jeb Keiper claims is more selective than Bristol Myers’ Sotyktu.
STAT News
SEPTEMBER 12, 2022
President Joe Biden plans to appoint longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health. Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized.
Bio Pharma Dive
SEPTEMBER 12, 2022
You need current, reliable data, but other factors are critical in assessing this information.
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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
STAT News
SEPTEMBER 12, 2022
You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system. Sign up here to get it in your inbox. Bucking the RUC. A heavyweight group of former Medicare officials and payment experts is calling on the federal government to overhaul how Medicare pays physicians, which they say has morphed into a system that is “mind-numbingly complex and nontransparent.
NPR Health - Shots
SEPTEMBER 12, 2022
A new study suggests that. yes, there are superdodgers. But explaining why they've been able to avoid the virus is a bit complicated.
STAT News
SEPTEMBER 12, 2022
A heavyweight group of former Medicare officials and payment experts are calling on the federal government to overhaul how Medicare pays physicians, which they say has morphed into a system that is “mind-numbingly complex and nontransparent.” One of the most integral components of this fee system is the American Medical Association’s Relative Value Scale Update Committee, or RUC, a group of 32 physicians that meets behind closed doors a few times every year.
NPR Health - Shots
SEPTEMBER 12, 2022
Drug price reforms passed as part of the Inflation Reduction Act did not solve the problem of skyrocketing costs of insulin. States are taking their own action.
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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.
STAT News
SEPTEMBER 12, 2022
Even before the new Covid booster shots arrived, the arguments about them got shrill. There’s a dizzying kaleidoscope of defensible opinions about the new Covid shots, which are designed to match the BA.5 strain of the virus that currently accounts for 9 in 10 Covid cases in the U.S.
NPR Health - Shots
SEPTEMBER 12, 2022
Dr. Demetre Daskalakis is steering the U.S. monkeypox response. A month into the job, he sees signs of success, but there's still more to be done.
STAT News
SEPTEMBER 12, 2022
Clinical trial results reported Monday by Amgen may be enough to confirm the U.S. approval of its KRAS-targeting lung cancer drug called Lumakras. But the new data also show lung cancer patients are not benefiting from Lumakras as much as previously hoped, and liver toxicity remains a safety concern. In the study, called CodeBreaK 200, Lumakras delayed tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel — a lower-than-expected improvement that non
NPR Health - Shots
SEPTEMBER 12, 2022
For some people, a rare genetic mutation makes dementia inescapable. Three sisters have decided to confront fate with a genetic test and have joined a research project on possible treatments.
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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.
pharmaphorum
SEPTEMBER 12, 2022
BioNTech has been thrust into the limelight with its mRNA-based vaccines and therapeutics – most notably its Pfizer-partnered COVID-19 shot – but the other side of its business is CAR-T therapies for cancer, and it is making progress in this area as well. At the ESMO congress the German biotech reported updated results from a phase 1/2 trial of its lead candidate BNT-211 for solid tumours, which consists of a CAR-T directed at the antigen Claudin-6 on cancer cells, coupled with an mRNA vaccine (
STAT News
SEPTEMBER 12, 2022
After decades of research documenting the profound effects of social factors on health , such as income, education, employment, food security, and neighborhood, the health care sector has finally begun grappling with these so-called social drivers of health. The health care system’s response has included efforts to identify patients and families experiencing social risk factors.
XTalks
SEPTEMBER 12, 2022
After approvals in Japan and Europe, Sanofi’s Xenpozyme has secured one from the US Food and Drug Administration (FDA) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. ASMD is a rare genetic lysosomal storage disease caused by mutations in the sphingomyelin phophodiesterase-1 ( SMPD1 ) gene that codes for the acid sphingomyelinase (ASM) enzyme.
STAT News
SEPTEMBER 12, 2022
In the life sciences industry, where company names derived from “biology” or “genetics” are a dime a dozen, it helps to have a brand that stands out. Pretzel Therapeutics is one of this year’s more creative gambits, launching Monday with $72.5 million in series A financing — just in time for Oktoberfest season.
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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.
ACRP blog
SEPTEMBER 12, 2022
Modern concepts of self-leadership were initially proposed in 1986 by Charles Manz, the Nirenberg Chaired Professor of Business Leadership at the University of Massachusetts. According to his viewpoint, the self-leadership process begins when a person compares the present condition of a perceived circumstance to a self-set standard. Assessment is then made regarding the normal and current state gap, and behavior is applied to reduce the gap.
STAT News
SEPTEMBER 12, 2022
Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, calls, and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing a cup of stimulation. Our choice today is salted caramel mocha.
Antidote
SEPTEMBER 12, 2022
There are many factors one should consider before deciding to enroll in a clinical trial. Though every clinical trial is designed to help researchers advance their knowledge about a specific condition, the details regarding a study’s duration, risks, benefits, and required time commitment can vary. When determining how to participate in clinical trials, these elements are all good things to discuss with the research team to determine if a study is a good fit.
BioPharma Reporter
SEPTEMBER 12, 2022
A US federal judge ruling that a Californian clinicâs stromal vascular stem cell treatments do not fall under the FDA's regulatory jurisdiction is of significant concern, says the ISCT.
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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
SEPTEMBER 12, 2022
Collaboration will involve sophisticated screening for cardiac-based drug discovery
pharmaphorum
SEPTEMBER 12, 2022
Mobile health specialist Happitech has launched software that it says can help researchers use photoplethysmography (PPG) technology in the development of applications for use in cardiovascular care. The FastStart Research app is designed to be used with optical PPG sensors that can measure heart rate, heart rate variability, and atrial fibrillation (AF) and are increasingly being deployed in smartphones and wearable devices such as Google’s Fitbit range and the Apple Watch.
Pharma Times
SEPTEMBER 12, 2022
Tislelizumab shows favourable safety profile compared to sorafenib among liver cancer patients
JAMA Internal Medicine
SEPTEMBER 12, 2022
This population-based prospective cohort study using UK Biobank data for 78 500 individuals with 7 years of follow-up examines associations of daily step counts and intensity with all-cause mortality and cancer and cardiovascular disease-related morbidity and mortality.
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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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