Summit lung cancer drug shows ‘striking’ benefit over Keytruda
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.
September, 2024
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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.
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A Common Sleeping Pill May Reduce Buildup of Alzheimer’s Proteins, Study Finds
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.
September 11, 2024: HARMONIE and a New Approach to Commercial Clinical Trials, in This Week’s PCT Grand Rounds
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
AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg
Fierce Pharma
SEPTEMBER 5, 2024
AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.
Novel drug reduces neuronal death in neurodegenerative disease
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
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How to optimize efficiencies at site-centric clinical trials
Pharmaceutical Technology
SEPTEMBER 4, 2024
By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.
Scientists Reveal The Absolute Worst Thickness For a Paper Cut
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.
September 4, 2024: NIH HEAL Initiative Supports New Funding Opportunity for Pragmatic Trials in the Pain Management Collaboratory
Rethinking Clinical Trials
SEPTEMBER 4, 2024
The National Center for Complementary and Integrative Health (NCCIH), with support from the Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , published a notice of funding opportunity for pragmatic clinical trials within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-011).
Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer
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.
The New Age of Decentralized Clinical Trials
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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
The Life Sciences Generative AI Council and a sustainable technological future
pharmaphorum
SEPTEMBER 5, 2024
Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.
Gene therapy startup emerges with green light for first-of-its-kind trial
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.
Prodrugs and patents: Enhancing therapy adherence and reducing side effects
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.
Type 2 Diabetes Drug Linked to 35% Lower Dementia Risk in Patients
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Digital Solution Implementation
Pharmaceutical Commerce
SEPTEMBER 9, 2024
In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.
With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug
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.
Apple AirPods get FDA okay for use as OTC hearing aids
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.
New research could ease concerns over suicide risk of obesity drugs
Bio Pharma Dive
SEPTEMBER 3, 2024
While results from two after-the-fact analyses were “reassuring,” outside experts urged “continued vigilance” to ensure GLP-1 drugs don’t worsen problems in people with preexisting mental health conditions.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Novavax wins FDA emergency approval for updated Covid-19 vaccine
Pharmaceutical Technology
SEPTEMBER 2, 2024
The US regulatory agency has also approved updated versions of Covid-19 vaccines from Moderna and Pfizer / BioNTech’s in the past two weeks.
Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules
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.
The ‘Rule of Three’: How the FDA is Hacking Drug Prices
Drug Patent Watch
SEPTEMBER 12, 2024
In the labyrinthine world of pharmaceuticals, where the cost of life-saving medications can often feel like a roll of the dice, the FDA is implementing a strategy that aims to bring some much-needed transparency and affordability to the market. This strategy, known as the ‘Rule of Three,’ is a game-changer in the battle against soaring drug prices.
After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug
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.
2022 Research: The Rapid Rise of Ocean Freight Visibility
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.
Meet MILTON, AZ's AI that can predict 1,000+ diseases
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
ArsenalBio raises $325M in one of the year’s largest biotech funding rounds
Bio Pharma Dive
SEPTEMBER 4, 2024
The funding comes amid a slowdown in venture investment for gene and cell therapy startups, and will support development of multiple solid tumor programs.
ESC 2024: GLP-1RAs show lower CV risk in 32,883-strong meta-analysis
Pharmaceutical Technology
SEPTEMBER 2, 2024
GLP-1RAs’ reduce CV risk, including reducing all-cause mortality and risk of MI, promoting weight loss and enhancing blood pressure control.
DoP to frame ‘Disposal Policy’ for safe removal of unused and expired drugs from household & sale premises
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 10, 2024
In order to avoid environmental hazards due to pharmaceutical products, the Department of Pharmaceuticals (DoP) is thinking of framing a ‘Disposal Policy’ for removing the unused and date-expired drugs from the sale premises and from the households.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
GSK’s Depemokimab Significantly Reduces Asthma Exacerbations
Pharmaceutical Commerce
SEPTEMBER 10, 2024
A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.
After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned
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.
Starmer says no extra NHS funding without big reforms
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
Lilly builds case for weekly insulin shot
Bio Pharma Dive
SEPTEMBER 5, 2024
New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.
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