Bio Pharma Dive
JUNE 13, 2024
Investor enthusiasm for precision immunology medicines is providing a tailwind for Santa Ana Therapeutics, a new startup backed by Versant, GV and a16z, among others.
Pharmaceutical Technology
JUNE 13, 2024
The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.
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Bio Pharma Dive
JUNE 13, 2024
The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.
Pharmaceutical Technology
JUNE 13, 2024
Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).
Bio Pharma Dive
JUNE 13, 2024
Trial data suggest the shot — an important component of an upcoming combination inoculation — has proven at least as effective, and in some cases superior, to the company’s initial COVID vaccine.
Rethinking Clinical Trials
JUNE 13, 2024
Dr. Diana Burgess Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based interventions via telehealth for veterans with chronic pain.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Transitional Cell Carcinoma (Urothelial Cell Carcinoma).
BioSpace
JUNE 13, 2024
While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.
Pharmaceutical Technology
JUNE 13, 2024
Two Hepatitis B and coeliac disease candidates will be the priority for the company whilst a prostate cancer asset appears to be sidelined.
FDA Law Blog
JUNE 13, 2024
By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.
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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
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Triple-Negative Breast Cancer (TNBC).
XTalks
JUNE 13, 2024
As reported by Statista, in 2021, the US allocated 17.8 percent of its gross domestic product (GDP) to healthcare, amounting to a whopping 4.4 trillion US dollars in 2022. The burden of chronic diseases and obesity is particularly severe in the US; the 2020 Commonwealth Fund International Health Policy Survey revealed that 30.4 percent of adults reported having two or more chronic conditions such as heart disease, diabetes and depression.
Pharmaceutical Technology
JUNE 13, 2024
PF-07960613 is under clinical development by Pfizer and currently in Phase II for Respiratory Syncytial Virus (RSV) Infections.
BioSpace
JUNE 13, 2024
Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.
Pharmaceutical Technology
JUNE 13, 2024
The new guidelines outline ways to develop NHS-industry partnerships and follow the ABPI’s manifesto.
pharmaphorum
JUNE 13, 2024
Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Pancreatic Ductal Adenocarcinoma.
BioSpace
JUNE 13, 2024
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
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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.
Pharmaceutical Technology
JUNE 13, 2024
GSK has entered into a multi-year data licence agreement with Ochre Bio, aiming to advance the understanding of liver disease.
Fierce Pharma
JUNE 13, 2024
With a phase 3 miss following a fatality in a related study and marking what analysts are calling the “final nail” in Pfizer’s Duchenne muscular dystrophy (DMD) gene therapy coffin, Sarepta Therape | With a phase 3 miss and severe safety signals, Pfizer's Duchenne muscular dystrophy gene therapy candidate is no competition to Sarepta's established Elevidys, according to analysts.
Pharmaceutical Technology
JUNE 13, 2024
NHS England chief executive Amanda Pritchard laid out a three-point plan to help support the future of the health service.
Fierce Pharma
JUNE 13, 2024
Pfizer's oncology division plans to have eight blockbusters by 2030, with contributions from each of its four focused therapeutic areas.
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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
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Non-Small Cell Lung Cancer.
Outsourcing Pharma
JUNE 13, 2024
To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Renal Cell Carcinoma.
pharmaphorum
JUNE 13, 2024
Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome
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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.
Pharmaceutical Technology
JUNE 13, 2024
NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Endometrial Cancer.
XTalks
JUNE 13, 2024
Eating a healthy, balanced diet is no longer just about getting the right mix of vitamins, minerals, carbohydrates, protein and fat. Now, it’s also about balancing one’s needs with the needs of the planet. One effective way to do this is by focusing on the best foods for the environment. These foods not only support one’s health but also have minimal impact on the planet.
Pharmaceutical Technology
JUNE 13, 2024
Flagship Pioneering and ProFound Therapeutics partnered to detect new therapeutics for the treatment of obesity.
pharmaphorum
JUNE 13, 2024
Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.
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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.
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