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A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t
The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.
The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.
Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult
The company, which is only three years removed from one of biotech’s most lucrative IPOs, will cut jobs for a third time and invest more heavily in cell therapies for diabetes and lupus.
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The company, which is only three years removed from one of biotech’s most lucrative IPOs, will cut jobs for a third time and invest more heavily in cell therapies for diabetes and lupus.
Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.
Rallybio is headed into a mid-stage trial with enough cash to last it through 2026, but biotech's down market has made the company's journey difficult.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.
Polyrizon Ltd., an Israeli biotech company specializing in medical device hydrogels, recently closed its initial public offering (IPO), raising $4.2 million in gross proceeds. The IPO, priced at $4.38 per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 per share.
Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.
AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a local report fueled fears of a potentially escalating insurance fraud investigation in China. | AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a report fueled fears of a potentially escalating insurance fraud investigation in China.
Sagimet Biosciences has announced that its experimental drug, denifanstat, will be heading into Phase III clinical trials for metabolic-associated steatohepatitis (MASH). The US Food and Drug Administration (FDA) has supported its advancement after the drug posted positive Phase II data. At the beginning of last month, the agency granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH.
Learn the importance of having a standardised data model as your single source of truth in this insightful video interview. Gain valuable insights on data management and standardisation processes.
Percussionaire has issued a Class I recall for certain lots of its Phasitron 5 breathing circuits, crucial components in intrapulmonary percussive ventilation (IPV) therapy, which aids breathing and keeps airways clear for patients on mechanical ventilation. The US Food and Drug Administration (FDA) marked this as a Class I recall, warning of a serious risk if affected devices are still in use.
Despite witnessing modest growth in demand over the past three months, Apellis Pharmaceuticals’ complement inhibitor for geographic atrophy (GA), Syfovre, may have hit a performance “nadir” in 2024 | Over the latest earnings stretch, Apellis' Syfovre saw sales down about 2% from the previous quarter despite an overall demand increase of about 7%.
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.
Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.
Septerna, Inc., a clinical-stage biotech company focused on pioneering therapies based on G protein-coupled receptors (GPCRs), recently completed its initial public offering (IPO), marking a significant milestone for the South San Francisco-based firm. Known for its innovative approach to GPCR drug discovery, Septerna leveraged its proprietary Native Complex Platform to establish a robust pipeline targeting endocrinology, immunology, inflammation and metabolic diseases.
Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.
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
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