Pharmaceutical Technology
SEPTEMBER 11, 2024
As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 9, 2024
(Derek Berwin/Getty Images) TThe human papillomavirus (HPV) is responsible for the vast majority of cervical cancer cases, but this isn’t a sexually transmitted infection that just one half of the population needs to worry about.
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XTalks
SEPTEMBER 9, 2024
Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. It is important for the principles of DEI to be understood for their goals, intended outcomes and applications; otherwise, they may be regarded as mere buzzwords or just another box to tick on organizational mandates. DEI are critical components of building a thriving, fair, all-encompassing, respectful and innovative society.
Drug Patent Watch
SEPTEMBER 11, 2024
The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of nanotechnology. This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients.
Bio Pharma Dive
SEPTEMBER 10, 2024
A small, early study produced what one analyst called “highly compelling” results that lifted the company’s shares by as much as 15% Tuesday.
Fierce Pharma
SEPTEMBER 10, 2024
After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
SEPTEMBER 10, 2024
Adaptin Bio has announced that the FDA has given the green light to start phase 1 clinical trials for its program APTN-101 targeting glioblastoma, the most common and aggressive form of brain cancer.
pharmaphorum
SEPTEMBER 11, 2024
A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis
Bio Pharma Dive
SEPTEMBER 12, 2024
The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.
Pharmaceutical Technology
SEPTEMBER 13, 2024
R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 13, 2024
Illustration of a cancer cell. (Science Photo Library/Canva Pro) Scientists have discovered a remarkable way to destroy cancer cells. Stimulating aminocyanine molecules with near-infrared light caused them to vibrate in sync, enough to break apart the membranes of cancer cells. [link] Aminocyanine molecules are already used in bioimaging as synthetic dyes.
Rethinking Clinical Trials
SEPTEMBER 11, 2024
Professor Saul Faust In this Friday’s PCT Grand Rounds, Saul Faust of the University of Southampton will present “The HARMONIE Trial: Reimagining How to Design and Deliver Contract Commercial Clinical Trials.” The Grand Rounds session will be held on Friday, September 13, 2024, at 1:00 pm eastern. The HARMONIE trial was a pragmatic trial of the effect of nirsevimab on hospitalizations for respiratory syncytial virus–associated lower respiratory tract infection when administered
Bio Pharma Dive
SEPTEMBER 8, 2024
Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.
Pharmaceutical Technology
SEPTEMBER 13, 2024
The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 11, 2024
(nomadsoulphotos/Canva) A Korean study published recently suggests people with type 2 diabetes who are prescribed a particular class of drug might be at a significantly lower risk of dementia.
Fierce Pharma
SEPTEMBER 8, 2024
The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.
Bio Pharma Dive
SEPTEMBER 12, 2024
Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.
Pharmaceutical Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 8, 2024
(Tero Vesalainen/iStock/Getty Images) There’s still so much we don’t know about Alzheimer’s disease, but the link between poor sleep and worsening disease is one that researchers are exploring with gusto.
Fierce Pharma
SEPTEMBER 12, 2024
Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.
Bio Pharma Dive
SEPTEMBER 13, 2024
During an investor presentation Thursday, executives admitted to being overly optimistic their vaccine could wrest significant market share away from GSK's and Pfizer's products this year.
Pharmaceutical Technology
SEPTEMBER 10, 2024
Baltimore opted out of a national settlement last year, instead pursuing its own claim against the opioid manufacturer.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 9, 2024
The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.
Fierce Pharma
SEPTEMBER 13, 2024
It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.
Bio Pharma Dive
SEPTEMBER 12, 2024
The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago.
Pharmaceutical Technology
SEPTEMBER 12, 2024
The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 10, 2024
(cookiecatagency/Getty Images) It’s happened to the best of us. There you are, minding your own business, sealing envelopes or replacing the printer ream, and tsssss ouch! A freshly minted paper cut, oozing ruby-red human juice, all over the clean white surface.
Fierce Pharma
SEPTEMBER 12, 2024
Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.
Bio Pharma Dive
SEPTEMBER 9, 2024
A once-daily pill the biotech is developing helped some people with obesity lose more than 5% of their weight in a month, spurring a stock bump and plans to bring the drug into further testing.
Pharmaceutical Technology
SEPTEMBER 9, 2024
PRV-3279 is under clinical development by Sanofi and currently in Phase II for Systemic Lupus Erythematosus.
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