XTalks
APRIL 16, 2025
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.
Rethinking Clinical Trials
APRIL 17, 2025
Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. The work, which was supported by the NIH Pragmatic Trials Collaboratory’s Distributed Research Network and by a grant from the National Institute on Aging, was published this week in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.
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Bio Pharma Dive
APRIL 16, 2025
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.
Pharmaceutical Technology
APRIL 15, 2025
At the ESCMID Global conference in Austria, the development of climate-informed infectious disease risk management systems was discussed.
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.
Worldwide Clinical Trials
APRIL 15, 2025
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.
Rethinking Clinical Trials
APRIL 16, 2025
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 14, 2025
Kyowa Kirin has concluded the construction of its new drug substance (DS) manufacturing facility, the HB7 building in Japan.
XTalks
APRIL 15, 2025
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.
Rethinking Clinical Trials
APRIL 15, 2025
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.
Bio Pharma Dive
APRIL 18, 2025
The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could be in store for an agency already shaken by large-scale layoffs.
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Pharmaceutical Technology
APRIL 14, 2025
Phase Ib results show VERVE-102 reduced LDL-C levels with no serious safety issues, unlike Verves VERVE-101 programme.
XTalks
APRIL 15, 2025
This World Hemophilia Day 2025, the bleeding disorders community comes together under the theme Access for all: Women and girls bleed too, spotlighting the long-overlooked experiences of women and girls with inherited bleeding disorders. Hemophilia occurs when a clotting protein is missing or deficient, causing prolonged bleeding that can lead to joint damage and chronic pain.
Drug Patent Watch
APRIL 14, 2025
"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.
Bio Pharma Dive
APRIL 16, 2025
The biotech is developing an experimental drug for the most common of a family of disorders all caused by errors in glycosylation.
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!
Pharmaceutical Technology
APRIL 14, 2025
Sandoz is suing Amgen over alleged patent abuse delaying the US launch of a biosimilar to the autoimmune drug Enbrel.
XTalks
APRIL 15, 2025
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.
Pharma Times
APRIL 17, 2025
More than 37 million adults in the US are affected by migraine
Bio Pharma Dive
APRIL 16, 2025
The advisory committee, which met Tuesday for the first time since Robert F. Kennedy Jr. was sworn in as health secretary, also discussed the Texas measles outbreak.
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
Pharmaceutical Technology
APRIL 16, 2025
The agreement is seen as a win for global health ahead of the US withdrawal from the WHO and amidst foreign aid cuts by the US government.
Drug Patent Watch
APRIL 16, 2025
"Patent Expiration: The Secret to Unlocking $100 Billion in Pharmaceutical Value Did you know that patent expirations in the pharmaceutical industry are projected to unlock over $100 billion in new business opportunities? At Drug Patent Watch, we've analyzed the latest data to reveal the top 5 therapeutic areas poised for disruption. From oncology to cardiovascular disease, we've identified the key trends and insights you need to know to make informed investment decisions.
XTalks
APRIL 14, 2025
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
Bio Pharma Dive
APRIL 16, 2025
The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about $29 million upfront.
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
Pharmaceutical Technology
APRIL 15, 2025
The FDA will require an additional Phase III trial for apraglutide, the company's candidate for short bowel syndrome.
ACRP blog
APRIL 14, 2025
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.
FDA Law Blog
APRIL 14, 2025
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.
Bio Pharma Dive
APRIL 14, 2025
As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S. tariffs on their products.
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XTalks
APRIL 15, 2025
The landscape of rare disease clinical trials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes. In a recent interview, Anthea Cherednichenko, MPH, MBA, Vice President, Hematology Franchise Head at Takeda, shared insights with Xtalks into the evolving clinical trial environment, the role of technology and the importance of partnerships in advan
Pharmaceutical Technology
APRIL 18, 2025
The agreement adds to Eli Lillys growing portfolio of AI-enabled drug discovery partnerships.
Pharma Times
APRIL 16, 2025
European Commission grants authorisation for Eisai and Biogen therapy
Bio Pharma Dive
APRIL 18, 2025
Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” biotech companies that have suffered significant setbacks.
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