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Dr. Sanjit Jolly In this Friday’s PCT Grand Rounds, Sanjit Jolly of McMaster University will present “Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial.” The Grand Rounds session will be held on Friday, April 18, 2025, at 1:00 pm eastern. Jolly is an interventional cardiologist at Hamilton Health Sciences and the Stuart Connolly Chair in Cardiology and a professor of medicine at McMaster University.
The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.
The Indian pharmaceutical industry is at the forefront of a transformative effort to make CAR-T cell therapy more affordable and accessible, offering renewed hope to cancer patients nationwide. This cutting-edge treatment, particularly effective against blood cancers such as leukaemia and lymphoma, has remained prohibitively expensive due to its complex manufacturing process and high international pricing.
The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). This marks BioconBiologics seventh biosimilar cleared for use in the US. Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). By preventing VEGF from binding its receptors on blood vessel linings, the drug cuts off tumors oxygen and nutrient supply.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
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 TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis.
Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Despite their clinical heterogeneity, these diseases often share overlapping pathological mechanisms, including protein misfolding and aggregation, synaptic dysfunction, neuroinflammation, and axonal degeneration.
Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Despite their clinical heterogeneity, these diseases often share overlapping pathological mechanisms, including protein misfolding and aggregation, synaptic dysfunction, neuroinflammation, and axonal degeneration.
Fast Companys annual Most Innovative Companies list recognizes leaders across industries and in 2025, food once again stole the spotlight. This years honorees tackle the sectors biggest challenges: cutting waste, boosting nutrition and engineering better flavor without compromise. Fast Company also flagged four foodtech trends to likely define 2025: personalized nutrition powered by data, AIenabled product development, alternativeprotein scaleup and robotics in processing.
"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies. At DrugPatentWatch, we've seen firsthand the importance of staying on top of regulatory changes and maintaining a robust compliance program.
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
This is a sponsored message. Technology has undeniably contributed to growing chaos at research sites. Seventy percent of sites report using more than six systems per trial, and for the first time, managing these systems is their top challenge. The impact is significant: 52% of sites are struggling to take on new studies, and sponsors are seeing a 45% increase in timelines from protocol approval to first-patient-first-visit.
The FDA has authorized the marketing of CT-132, a prescription digital therapeutic (DTx) developed by Click Therapeutics for the preventive treatment of episodic migraine in adults. CT132 is the first FDA-cleared digital therapeutic for migraine prevention, expanding treatment options beyond conventional medications. It also aligns with the growing interest in software-based interventions.
"Unlocking New Hope for Neurological Disorders As we continue to push the boundaries of medical innovation, I'm excited to share with you a game-changing development in the fight against neurological disorders. At the forefront of this revolution is AI-based drug repurposing. By leveraging cutting-edge technology, researchers are re-examining existing medications to identify new uses for treating conditions such as Alzheimer's, Parkinson's, and multiple sclerosis.
By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV). As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards.
Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.
The FDA has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. GSKs Blujepa represents the first new oral antibiotic in almost 30 years to address the growing challenge of antibiotic resistance in UTIs. uUTIs are the most common type of bacterial infection, affecting up to 16 million women in the US each year.
What if the next patient who needs your medication is already searching onlineand youre not there? In today’s competitive healthcare landscape, PPC campaigns (Pay-Per-Click advertising) have emerged as a critical lever for pharma marketers aiming to deliver timely, targeted, and measurable impact. Gone are the days when print ads and in-person detailing alone could carry a brand.
Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.
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.
On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods. The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. For years, drug makers have relied on animal studies using rodents, dogs or primates to flag safety concerns, even though these models often fall short in pred
Exercise therapy is suggested as a first-line treatment to improve joint pain and loss of function caused by osteoarthritis (OA), a musculoskeletal disorder that affects more than 595 million people worldwide. Yoga and strengthening exercises are both known to be effective ways of managing knee OA, but is one better than the other?
By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Soleno Therapeutics has announced the FDA approval of Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia an intense, persistent hunger in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder. After a series of failures in the indication, Soleno has achieved a breakthrough with the approval.
In a highly regulated industry like pharmaceuticals, standing out online can feel like navigating a maze. Unlike retail or tech brands, pharma companies must balance compliance with creativity while communicating with multiple audiences. This is where SEO marketing strategies become essentialallowing brands to boost visibility, earn trust, and support both HCP and patient journeys without violating regulatory guidelines.
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
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