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 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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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 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.
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
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
pharmaphorum
SEPTEMBER 13, 2024
It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.
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 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.
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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
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.
Drug Discovery World
SEPTEMBER 12, 2024
New research has shown that Ellorarxine, a novel drug compound developed by biotech Nevrargenics, provides a robust neuroprotective effect and reduces neuronal death in cell models of neurodegenerative disease. The peer reviewed study published in Frontiers in Neuroscience was conducted by academics at Aberdeen and Durham Universities in the UK. Based on the results, the company has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to run a human study in the
Fierce Pharma
SEPTEMBER 13, 2024
Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.
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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.
Bio Pharma Dive
SEPTEMBER 13, 2024
Roche has now beat Merck and Bristol Myers to market with its under-the-skin immunotherapy. Elsewhere, Sanofi bought into radiopharmaceuticals and Mene Pangalos joined Biogen's board.
Pharmaceutical Technology
SEPTEMBER 9, 2024
KOS-1803 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Solid Tumor.
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.
pharmaphorum
SEPTEMBER 13, 2024
Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.
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
SEPTEMBER 13, 2024
When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.
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 9, 2024
PRV-3279 is under clinical development by Sanofi and currently in Phase II for Systemic Lupus Erythematosus.
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.
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
SEPTEMBER 12, 2024
Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms
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 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.
Pharmaceutical Technology
SEPTEMBER 11, 2024
EASD 2024 participants are looking for the hottest efficacy data to make predictions on the next trend in the metabolic space.
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.
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
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.
Bio Pharma Dive
SEPTEMBER 11, 2024
Data from an early trial of the therapy fell short of the company’s “threshold to warrant additional capital investment,” an executive said.
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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.
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