Bio Pharma Dive
OCTOBER 10, 2022
Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH. The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 10, 2022
A three-year-long study has tracked dozens of patients with an ultra-rare disorder that gradually turns muscle, tendons, and ligaments to bone. The lifelong, irreversible condition is known as fibrodysplasia ossificans progressiva (FOP). While estimates on its prevalence vary, confirmed cases occur in roughly one out of every 1 to 2 million births. Only about 800 […].
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Bio Pharma Dive
OCTOBER 10, 2022
The company said it will work with the FDA to address issues flagged by the agency in a complete response letter for the apomorphine infusion device.
Pharmaceutical Technology
OCTOBER 10, 2022
Health Canada has approved Pfizer ’s subsidiary Pfizer Canada and BioNTech’s bivalent Covid-19 vaccine, Comirnaty, as a 30?g booster shot for 12 years and above aged individuals. The regulatory approval for Comirnaty Original & Omicron BA.4/BA.5 booster dose is based on the clinical data obtained from the companies’ monovalent, Omicron BA.1-adapted bivalent vaccine.
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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
OCTOBER 10, 2022
By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product.
Pharmaceutical Technology
OCTOBER 10, 2022
Concept: Indian software development startup Lucidity has launched an autonomous storage orchestration solution called Lucidity Auto-Scaler to keep cloud block storage neat, tidy, and cost-efficient. Lucidity claims its no operations (NoOps) orchestration layer can make a company’s cloud block storage 70% cheaper and 10 times faster, without any code changes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 10, 2022
The China National Medical Products Administration (NMPA) has approved Innovent Biologics ’ new drug application (NDA) for selpercatinib to treat lung and thyroid cancers. Selpercatinib obtained the approval to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
Bio Pharma Dive
OCTOBER 10, 2022
A monitoring committee recommended the mid-stage trial continue after reviewing preliminary results. The drug, called reldesemtiv, previously fell short in Phase 2.
Pharmaceutical Technology
OCTOBER 10, 2022
The health concern over COVID-19 in September 2022 increased by two percentage points to 24.5%, compared to 22.3% recorded in August 2022 , shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly con
NPR Health - Shots
OCTOBER 10, 2022
Everything from your vocal cord vibrations to breathing patterns when you speak offers potential information about your health. Researchers are collecting voice data to one day use in an app.
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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
OCTOBER 10, 2022
Does eating red meat increase one’s risk of heart disease? Would eating more vegetables help? Is leaving high blood pressure untreated really a death wish? The answers might vary, depending on who a person asks, which friend or TikTok nurse, and when. Researchers at the University of Washington want to make it easier to find current, evidence-based health advice.
BioSpace
OCTOBER 10, 2022
Immatics announced plans to raise about $110 million in a common stock offering following the release of promising early-stage data that supports its ACTengine technology platform.
STAT News
OCTOBER 10, 2022
I first met Wes Ely in 2016, when I wrote about ICU delirium and Ely’s attempts, as a critical-care physician at Vanderbilt University Medical Center, to urge fellow health care workers to rethink the use of heavy sedation in ICUs. His research was an attempt to limit the crippling cognitive and physical impairments he saw develop in many critical-care patients long after they left the hospital, something he came to call post intensive care syndrome, or PICS.
pharmaphorum
OCTOBER 10, 2022
For the 32 million individuals in the US with food allergies, more research into symptoms, causes, and treatments has been long sought after, but historically underfunded. The National Institutes of Health (NIH), which oversees disease research, has a total annual budget equivalent to $120 per person, with only $0.19 per person being spent on food allergy research.
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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
OCTOBER 10, 2022
Merck said Monday the key drug from its $11.5 billion purchase of the biotech Acceleron met its main goal in a key clinical trial. The medicine, sotatercept, is meant to treat pulmonary arterial hypertension, a disease in which high blood pressure in the arteries of the lungs leads to difficulty breathing and walking. Merck did not disclose detailed results in its press release, but said that the medicine resulted in a “statistically significant and clinically meaningful” increase
BioPharma Reporter
OCTOBER 10, 2022
Colossal Biosciences spins out Form Bio, which emerges with funding and a software platform that is designed to be used across drug discovery, cell and gene therapy, manufacturing, and academic research.
STAT News
OCTOBER 10, 2022
One child dies every two minutes from malaria. Wider use of a new vaccine can make a dent in that devastating statistic. The World Health Organization recommends the vaccine for broad use in sub-Saharan Africa and other areas with moderate to high malaria transmission, after years of studies in some 900,000 children showed it to be safe and effective.
NPR Health - Shots
OCTOBER 10, 2022
The mental health crisis and the shortage of providers to treat them is creating a parallel problem for families: debt. But how much Americans are having to pay for this care is hidden in the shadows.
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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.
STAT News
OCTOBER 10, 2022
The U.S. is about to have not just one, but two, standalone publicly-traded oncology providers. Florida-based American Oncology Network, a company with more than 100 affiliated doctors across 18 states, announced last week it plans to go public. The news comes about a year after another large oncology provider chain hit the stock market. Its shares have since lost roughly half their value.
NPR Health - Shots
OCTOBER 10, 2022
In the health industry, there is growing focus on providing effective therapies using on-demand care. That includes a hypnosis app to help manage the symptoms of irritable bowel syndrome.
STAT News
OCTOBER 10, 2022
After three years of probing, the European Commission has reached a preliminary decision that Teva Pharmaceuticals illegally used different strategies to prevent rival companies from introducing versions of a top-selling medicine. The review found that Teva used various patent maneuvers to thwart generic manufacturers from being able to market copycat versions of the Copaxone multiple sclerosis treatment.
Drug Discovery World
OCTOBER 10, 2022
By Dr Dina Finan, PhD, Product Manager at 10x Genomics and Dr Nick Downey, PhD, NGS Collaborations Lead at Integrated DNA Technologies. RNA sequencing has become a widely used tool that can explore the transcriptome in a seemingly endless number of applications. While bulk sequencing—or sequencing the transcriptome of an entire sample at once—has contributed to many [.].
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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.
STAT News
OCTOBER 10, 2022
Congress has taken the necessary step of including critical reauthorizations for the Prescription Drug User Fee Act in its continuing resolution that will avert a partial government shutdown. Successful reauthorization of the act, which sets the funding structure for the Food and Drug Administration, will ensure that it has the funds to fulfill its vital mission.
BioSpace
OCTOBER 10, 2022
One year after raising $500 million, Neumora Therapeutics secured an additional $112 million in a Series B financing round to support the advancement of its neuroscience portfolio.
Antidote
OCTOBER 10, 2022
October 10 is World Mental Health Day , a day aimed at raising awareness of mental health and wellness around the globe. For many mental health conditions , it can take a period of trial and error to find the right treatment plan for patients — but through clinical trials, discovering new and more efficient treatments can be made possible.
BioSpace
OCTOBER 10, 2022
ImmunityBio is laying off 38 employees at its Dunkirk site in New York, Amneal will shutter a Long Island facility and Rigel culls 30 employees following wAIHA regulatory decision.
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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
OCTOBER 10, 2022
Biogen has started a global Phase 2/3 study for litifilimab, a humanized IgG1 monoclonal antibody (mAb), in participants with cutaneous lupus erythematosus (CLE).
Pharma Times
OCTOBER 10, 2022
Medicines repurposing offers new avenues for treating a range of common and rare diseases
BioSpace
OCTOBER 10, 2022
Last week, rumors spread that PureTech Health was preparing to merge with Nektar Therapeutics. Now the deal, never officially announced, has been called off.
Pharma Times
OCTOBER 10, 2022
Partnership will evaluate AI-powered technology in lung cancer care
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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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