Bio Pharma Dive
NOVEMBER 15, 2024
At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.
Pharmaceutical Technology
NOVEMBER 18, 2024
During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,
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Pharmaceutical Technology
NOVEMBER 15, 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 13, 2024
(PeopleImages/Getty Images) For a long time it was assumed that somewhere between 5 and 6% of children have attention-deficit hyperactivity disorder ( ADHD). But the rates, in practice, are often higher. The American Centers for Disease Control and Prevention put the prevalence at 11.4% in children in 2022.
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
Rethinking Clinical Trials
NOVEMBER 19, 2024
Dr. Greg Simon Greg Simon, a longtime member of the Coordinating Center leadership team for the NIH Pragmatic Trials Collaboratory, was selected by the Health Care Systems Research Network (HCSRN) Governing Board of Directors to receive the organization’s inaugural Founders’ Award. The new award recognizes individuals who best exemplify the spirit of the HCSRN’s early founders in their service and lasting contributions to the network.
Worldwide Clinical Trials
NOVEMBER 13, 2024
By; Brooke Kaplan, Director, People Partner- HR Compliance & Human Capital Initiatives In April 2007, at 19 years old, I was a sophomore at the University of Maryland. I had always been relatively healthy, exercised recreationally, and worked part-time at the campus gym. I’d just returned from spring break at Disney World with my boyfriend (now husband), Zak, and we were gearing up for the Jewish holiday of Passover.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 14, 2024
BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 18, 2024
(Stefania Pelfini, La Waziya Photography/Getty Images) Some 2.3 million of U.S. adults over 65 – more than 4% – have a diagnosis of dementia. But even without a diagnosis, a certain amount of cognitive decline is normal as age sets in.
Rethinking Clinical Trials
NOVEMBER 13, 2024
In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at the University of Pennsylvania and the director of the Penn Medicine Nudge Unit, which “designs an
Fierce Pharma
NOVEMBER 19, 2024
Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.
Bio Pharma Dive
NOVEMBER 14, 2024
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
Pharmaceutical Technology
NOVEMBER 13, 2024
Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
(Taokinesis/Canva) Because there are typically no symptoms until the first fracture occurs, osteoporosis is considered a silent disease. Some call it a silent killer. Osteoporosis is a bone disease characterized by decreased bone density and strength, leading to fragile, brittle bones that increase the risk of fractures, especially in the spine, hips and wrists.
Rethinking Clinical Trials
NOVEMBER 20, 2024
Dr. Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif and Mary-Lou Hanna Chair in Surgical Oncology Research, a joint appointment at the Sunnybrook Research
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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
Fierce Pharma
NOVEMBER 18, 2024
Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.
Bio Pharma Dive
NOVEMBER 13, 2024
Biotheus’ antibody drug targets PD-L1 and VEGF, a design that’s high on drugmakers’ radars after the success of Summit Therapeutics’ ivonescimab over Keytruda.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 19, 2024
(Flavio Coelho/Moment/Getty Images) While it’s not possible to stop the brain from aging – at least not yet – there might be ways to slow down its decline, and a new study shows the vital role blood sugar levels play in how rapidly the brain ages.
Rethinking Clinical Trials
NOVEMBER 14, 2024
The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominati ons for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. The committee will include: health professionals and scientists who are leaders in the field of pain research patients with pain-related conditions, patient-advocates, and community organizations for individuals with pain-related conditions.
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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.
BioPharma Reporter
NOVEMBER 19, 2024
PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.
Bio Pharma Dive
NOVEMBER 18, 2024
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
Pharmaceutical Technology
NOVEMBER 18, 2024
The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 18, 2024
In a move to streamline its growing intellectual property (IP) management needs, the Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EOI) for the procurement of an online intellectual property management software. Technical proposals must be submitted by November 22, 2024, by 9:00 am.
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.
Fierce Pharma
NOVEMBER 19, 2024
Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.
pharmaphorum
NOVEMBER 18, 2024
Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).
Bio Pharma Dive
NOVEMBER 18, 2024
Explore solutions to reduce variability in gene expression during cell line development.
Pharmaceutical Technology
NOVEMBER 18, 2024
The US FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating acute leukaemia with KMT2A translocation.
Advertiser: FourKites
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 17, 2024
The Indian healthcare industry has made significant strides in improving the accessibility and effectiveness of epilepsy treatments in recent years. With the advent of new drugs, advanced surgical options, better diagnostic tools and increased awareness, epilepsy management has seen a positive transformation.
Fierce Pharma
NOVEMBER 13, 2024
As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.
pharmaphorum
NOVEMBER 19, 2024
Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.
Bio Pharma Dive
NOVEMBER 18, 2024
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain pediatric patients with an aggressive form of acute leukemia.
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