Pharmaceutical Technology
NOVEMBER 25, 2024
The biopharmaceutical industry is being called to take its sustainability efforts to the next level. A new report sheds light on the topic.
Bio Pharma Dive
NOVEMBER 25, 2024
The setback likely removes one competitor to an emerging spinal muscular atrophy medicine from Scholar Rock, but sets the stage for a pair of readouts with implications for weight loss research.
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Rethinking Clinical Trials
NOVEMBER 25, 2024
Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and saf
Bio Pharma Dive
NOVEMBER 25, 2024
Positive results from a study of Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.
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
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 25, 2024
Illustrative example of damaged skin, in this case from sunburn. (Jennifer A Smith/Getty Images) A rare and potentially fatal skin infection with nightmarish outcomes may soon have a cure.
Pharmaceutical Technology
NOVEMBER 25, 2024
GSK has received approval from Japan's MHLW for its application to extend the indication of its RSV vaccine, Arexvy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 25, 2024
China’s NMPA has approved MSD’s WELIREG (belzutifan) to treat adult individuals with certain types of VHL disease-associated tumours.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 25, 2024
Digital technologies have transformed biology research to provide in-depth insights into unravelling the mysteries of living systems. Bioengineering is the new frontier in advanced technology, said Kiran Mazumdar-Shaw, chairperson, Biocon Group and Association of Biotechnology Led Enterprises (ABLE). Genetic engineering has unleashed a power house of bio manufacturing in the fermentation industry.
Pharmaceutical Technology
NOVEMBER 25, 2024
The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.
Fierce Pharma
NOVEMBER 25, 2024
On a Zoom call last month from California, BridgeBio CEO Neil Kumar needled a colleague about the remote possibility of the New York Yankees rallying to win the World Series as they trailed the Los | The FDA has signed off on BridgeBio's Attruby (acoramidis), a potential blockbuster to treat patients with the rare heart disease transthyretin amyloid cardiomyopathy.
Pharmaceutical Technology
NOVEMBER 25, 2024
Since 2023, the pharmaceutical industry operating in Europe has faced an unprecedented challenge related to drug shortages.
pharmaphorum
NOVEMBER 25, 2024
IT industry group techUK has called on the government to guarantee funding for digital transformation and cyber resilience in health and social care.
Pharmaceutical Technology
NOVEMBER 25, 2024
The US FDA has approved BridgeBio Pharma’s Attruby (acoramidis) for treating adult individuals with ATTR-CM.
Fierce Pharma
NOVEMBER 25, 2024
Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition. | In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair met its primary endpoint of time to first morbidity or mortality event, which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening in patients with PAH.
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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
NOVEMBER 25, 2024
This latest raise is intended to accelerate the development of the biotech’s four antibody-drug conjugates.
Fierce Pharma
NOVEMBER 25, 2024
Incyte’s previously disclosed phase 3 win in relapsed or refract | In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb's Revlimid and Roche's Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan.
pharmaphorum
NOVEMBER 25, 2024
After a disappointing result with Truqap in triple-negative breast cancer, AstraZeneca chalks up a win in prostate cancer.
Fierce Pharma
NOVEMBER 25, 2024
Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. | Bristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. The company has handed pink slips to 195 more employees, according to a New Jersey Worker Adjustment and Retraining Notification (WARN) update.
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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.
XTalks
NOVEMBER 25, 2024
Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. Imkeldi introduces an accessible alternative to traditional tablets, particularly for those who struggle with swallowing or require customized dosing. Imkeldi’s innovative formulation provides consistent dosing accuracy while offering a palatable strawberry flavor and stable storage without refrigeration.
Fierce Pharma
NOVEMBER 25, 2024
After a recent failed showing in a breast cancer subgroup raised doubts around AstraZeneca’s Truqap, the first-in-class AKT inhibitor is making inroads in a prostate cancer subtype. | The AKT inhibitor's early win in a prostate cancer subtype follows a recent surprise flop in a breast cancer study. AZ has been working to grow Truqap beyond its current limited approval in a niche breast cancer category.
pharmaphorum
NOVEMBER 25, 2024
Watch this exclusive interview with health innovators Lori Fletcher and Amber Beimer from Advanced Clinical as they discuss the latest trends and advancements in the Functional Service Provider (FSP) field.
Pharmaceutical Commerce
NOVEMBER 25, 2024
In the second part of this roundtable discussion, key opinion leaders discuss the potential technological challenges surrounding RFID, and the likelihood of not only utilizing this tech at the item level but for product security purposes as well.
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.
pharmaphorum
NOVEMBER 25, 2024
Halozyme Therapeutics has withdrawn its offer to acquire Evotec, saying that the German company had been unwilling to engage with negotiations.
Antidote
NOVEMBER 25, 2024
November is National Caregivers Month, a time to celebrate and acknowledge the often-unseen heroes who provide vital support to individuals with chronic illnesses, disabilities, or age-related conditions. Whether they are family members, friends, or professional aides, caregivers offer essential day-to-day assistance that helps their loved ones maintain their health and quality of life.
Crucial Data Soutions
NOVEMBER 25, 2024
When it comes to managing imaging data in clinical trials, researchers find many challenges. Disjointed systems that don’t talk to. The post From Imaging to Analysis: 5 Steps for Success with TrialKit PACS appeared first on Crucial Data Solutions.
Drug Discovery World podcast
NOVEMBER 25, 2024
The latest episode of the DDW Highlights podcast is now available to listen to and watch below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This week’s most exciting news stories all represent innovative solutions to the treatment of disease, proving that ‘thinking outside the box’ can by the key to success in drug discovery.
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.
pharmaphorum
NOVEMBER 25, 2024
BridgeBio grabs FDA approval for its ATTR cardiomyopathy drug Attruby, setting up a challenge to market leader Pfizer
Pharma Times
NOVEMBER 25, 2024
Commit Biologics has appointed Mikkel Wandahl Pedersen as CSO
Drug Channels
NOVEMBER 25, 2024
Happy Thanksgiving, everyone! Before you stretch your stomach, stretch your mind with our extra-stuffed helping of food for thought. In this issue: Intriguing data on how employers oversee their PBMs State Medicaid programs carve out PBMs—and get a 340B windfall Are U.S. drug prices really higher than other countries? Plus, Dr. Glaucomflecken gets us ready for the open enrollment season.
Pharmaceutical Commerce
NOVEMBER 25, 2024
The CDMO’s offerings will now feature automated fill-finish.
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