Bio Pharma Dive
FEBRUARY 28, 2023
The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run.
Pharmaceutical Technology
FEBRUARY 28, 2023
The prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) continues to increase, compounded by risk factors such as advanced age, obesity, ethnicity, and type 2 diabetes mellitus (T2DM). As NAFLD progresses to NASH, the same factors also contribute to liver fibrogenesis (abnormal accumulation of fibrous tissue).
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Bio Pharma Dive
FEBRUARY 28, 2023
Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.
Pharmaceutical Technology
FEBRUARY 28, 2023
KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. According to GlobalData, Phase I drugs for Melanoma have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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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
FEBRUARY 28, 2023
An alliance with the startup brings Vertex an RNA-based medicine for the disease, adding to a portfolio that already includes a gene editing treatment.
Rethinking Clinical Trials
FEBRUARY 28, 2023
The Society for Medical Decision Making (SMDM) will host a free, live webinar on Thursday, March 2, to discuss equity and patient engagement. The webinar, “Equity in Medical Decision Making: Perspectives from Patient Partners and SMDM Members,” was organized by the SMDM Patient Advisory Council. From the announcement: In this webinar we will discuss equity, what it is and isn’t, the role of equity in medical decision making and gaps in the literature.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
FEBRUARY 28, 2023
95% of rare diseases don’t have a treatment approved and won’t anytime soon. Uplifting Athletes (UA) is on a mission to change that. Back in 2010, Rob Long was a 22-year-old football player at Syracuse University on the path towards his dream career of becoming a punter in the NFL. But just a few months before his college graduation and the start of his career, Rob’s dreams fell to pieces.
Pharmaceutical Technology
FEBRUARY 28, 2023
Dr Reddy’s Laboratories has signed a definitive agreement to buy Australian company Mayne Pharma Group’s US generic prescription product portfolio in a deal valued at approximately $105m. Under the deal, the company will buy the portfolio for around $90m in an upfront cash payment. It will also make contingent payments of up to $15m towards inventory and credits for certain accrued channel liabilities that will be determined on the closure date.
Bio Pharma Dive
FEBRUARY 28, 2023
The company is laying off 17% of its workforce and stopping work on inhaled JAK inhibitors in its latest restructuring move.
Pharmaceutical Technology
FEBRUARY 28, 2023
Rhythm Pharmaceuticals’ subsidiary Rhythm Pharmaceuticals Netherlands has purchased Dutch biotech company Xinvento and its portfolio of investigational therapeutics. Under the deal, Rhythm will acquire Xinvento’s 100% fully diluted equity for a $5m upfront payment and pay up to an additional $6m in preclinical development milestones. On receiving certain EU or US regulatory approvals, Rhythm will also pay up to an additional $50m.
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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
NPR Health - Shots
FEBRUARY 28, 2023
Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.
STAT News
FEBRUARY 28, 2023
Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!
NPR Health - Shots
FEBRUARY 28, 2023
When Lauren Miller found out one of her twins had a fatal condition, she discovered her doctors in Texas would only say: You need to leave the state. She went to Colorado for a selective reduction.
Pharmaceutical Technology
FEBRUARY 28, 2023
Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Paroxysmal Nocturnal Hemoglobinuria. According to GlobalData, Phase III drugs for Paroxysmal Nocturnal Hemoglobinuria have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Iptacopan hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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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.
NPR Health - Shots
FEBRUARY 28, 2023
Billing experts and lawmakers are playing catch-up as providers get around new consumer protections, leaving patients like Danielle Laskey of Washington state with big bills for emergency care.
Pharmaceutical Technology
FEBRUARY 28, 2023
MCLA-129 is under clinical development by Merus and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC). According to GlobalData, Phase II drugs for Esophageal Squamous Cell Carcinoma (ESCC) have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how MCLA-129’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
NPR Health - Shots
FEBRUARY 28, 2023
People's likeliness to wear a mask can depend on how attractive they deem themselves and how important it is to them to make a first impression given certain circumstances.
Pharmaceutical Technology
FEBRUARY 28, 2023
KFA-115 is under clinical development by Novartis and currently in Phase I for Malignant Mesothelioma. According to GlobalData, Phase I drugs for Malignant Mesothelioma have a 77% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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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.
NPR Health - Shots
FEBRUARY 28, 2023
When a dire disease strikes, it's easy to slip into war terms to describe the experience. But that sort of talk turns life into two outcomes: winning and losing. And that's not the way life works.
Pharmaceutical Technology
FEBRUARY 28, 2023
Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Glomerulonephritis. According to GlobalData, Phase III drugs for Glomerulonephritis have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Iptacopan hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Medical Xpress
FEBRUARY 28, 2023
A team of scientists from Scripps Research and the University of North Carolina (UNC) has found antibodies in the blood of certain COVID-19 donors that can block infection from a broad set of coronaviruses—specifically, in people who have recovered from the virus and were then vaccinated. They found this includes not only the COVID-19-causing SARS-CoV-2, but also SARS-CoV-1 and MERS-CoV.
NPR Health - Shots
FEBRUARY 28, 2023
PEPFAR is the "most amazing thing in the history of HIV," says Dr. Sharon Lewin, president of the International AIDS Society. Bush himself came to Washington this month to urge reauthorization.
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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.
Fierce Pharma
FEBRUARY 28, 2023
FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55
NPR Health - Shots
FEBRUARY 28, 2023
On Fox News, the FBI director reiterated the agency's assessment that COVID was unleashed after a potential lab incident. That's not the consensus among intelligence and scientific communities.
STAT News
FEBRUARY 28, 2023
SAN FRANCISCO — The mental health startup Mindstrong had the makings of a trailblazer in the field: top-tier leaders from companies like Google and Uber with expertise in neuroscience, medicine, and computer science. About $160 million from the same heavyweight Silicon Valley investors who bankrolled industry-shifting companies like Warby Parker and Airbnb.
Medical Xpress
FEBRUARY 28, 2023
A long-established Alzheimer's drug can help people with a disorder that causes them to compulsively pull at their hair or pick at their skin, a new clinical trial has concluded.
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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.
STAT News
FEBRUARY 28, 2023
My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the type known as CLN3 — is stealing his childhood. And then this rare disease will steal my child. Wheeler is missing the DNA needed to recycle a waste product called lipofuscin that his cells naturally produce. As lipofuscin builds up, his condition will get worse, robbing him of his eyesight, his speech, his mobility, and ultimately his life.
Medical Xpress
FEBRUARY 28, 2023
One in ten early deaths could be prevented if everyone managed at least half the recommended level of physical activity, say a team led by researchers at the University of Cambridge.
STAT News
FEBRUARY 28, 2023
Dementia thoroughly altered my dad — and our family — and taught me just how hard it can be to care for someone with dementia. When I don’t understand something, my impulse as a photojournalist is to do a story about it. That instinct, by way of a Facebook group for caregivers of people with dementia, connected me with Leandra and George Manos, whose lives I have been chronicling since the spring of 2021.
Medical Xpress
FEBRUARY 28, 2023
A team of reproductive specialists from Queens Medical Research Institute, Imperial College London and University College London, all in the U.K., has conducted a systematic review and associated meta-analysis of data on pregnant women receiving COVID vaccines. In their paper published in the journal Human Reproduction, the team reports that they found no increased risk of miscarriage by women receiving any of the COVID vaccines.
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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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