September, 2024

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Top three trends in precision medicine

Pharmaceutical Technology

An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.

Medicine 264
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Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

Bio Pharma Dive

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

Drugs 334
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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

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.

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Summit lung cancer drug shows ‘striking’ benefit over Keytruda

Bio Pharma Dive

Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.

Drugs 340
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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September 24, 2024: GRACE Team Identifies Barriers to Integrating Acupuncture Into US Healthcare System

Rethinking Clinical Trials

In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.

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Your Eyesight Could Be Putting You at Risk of Developing Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

(ImagesBazaar/Getty Images) A new study suggests staying on top of your eye health could offer a simple avenue for reducing your risks of future brain problems.

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AI-Powered chest X-Rays detect lung cancer early

Pharma Times

New evidence highlights AI’s potential in early lung cancer detection

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

Marketing 133
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A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

Bio Pharma Dive

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

Drugs 351
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September 12, 2024: NIH Collaboratory Biostatisticians Evaluate Analytic Models for Individually Randomized Group Treatment Trials

Rethinking Clinical Trials

Dr. Jonathan Moyer To avoid inflation in the rate of type 1 error, or false positives, in individually randomized group treatment (IRGT) trials, researchers should choose an analytic model that accounts for the correlations in outcome measures that arise when study participants receive an intervention from the same source, according to a report from the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core.

Trials 173
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Health ministry notifies Rules to register CROs under NDCTR, 2019

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union health ministry has issued final notification defining the clinical research organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The amended rules will come into force from April 1, 2025.

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“PBMs favour high list prices”- Novo Nordisk CEO targets PBMs in US Senate hearing

Pharmaceutical Technology

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

Insulin 312
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WHO adds first mpox vaccine to prequalification list

Pharma Times

The decision is expected to facilitate timely access to Bavarian Nordic’s Imvanex

Vaccine 131
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AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg

Fierce Pharma

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.

Drugs 134
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Three biotechs raise $700M in rare burst of IPO activity

Bio Pharma Dive

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.

Marketing 331
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September 25, 2024: Randomizing Entire Countries, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tom Lietman of the University of California, San Francisco, will present “Azithromycin for Childhood Mortality: Randomizing Entire Countries.” The Grand Rounds session will be held on Friday, September 27, 2024, at 1:00 pm eastern. Lietman is the Ruth Lee and Phillips Thygeson Distinguished Professor in the Department of Ophthalmology and the Department of Epidemiology and Biostatistics at the University of California, San Francisco, and the d

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Some Coffee And Tea Drinkers Could Be Lowering Their Risk of Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

(juanma hache/Getty Images) A new study has investigated whether drinking coffee or tea can reduce the risk of developing dementia, and the findings help explain some murky past results. Researchers at Ningxia Medical University in China have found that some coffee or tea drinkers are lowering their risk of dementia.

Research 228
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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

Drugs 310
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Why Nitrile Exam Gloves Are the Preferred Choice for Medical Professionals

Pharma Mirror

In healthcare, safety is always the top priority—whether it's protecting patients or the staff who care for them. Personal protective equipment (PPE) plays a vital role in ensuring this safety, and one item that stands out is nitrile exam gloves. The post Why Nitrile Exam Gloves Are the Preferred Choice for Medical Professionals appeared first on Pharma Mirror Magazine.

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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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ArsenalBio raises $325M in one of the year’s largest biotech funding rounds

Bio Pharma Dive

The funding comes amid a slowdown in venture investment for gene and cell therapy startups, and will support development of multiple solid tumor programs.

Gene 331
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September 16, 2024: Researchers Examine Feasibility of Enhanced TSOS Intervention for Trauma Survivors in Australia

Rethinking Clinical Trials

Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.

Research 162
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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.

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Psychologist Explains How to Stop Using Food as a Coping Mechanism

AuroBlog - Aurous Healthcare Clinical Trials blog

(Aja Koska/E+/Getty Images) Have you ever noticed changes in your eating habits when you are sad, bored or anxious? Many people report eating either more, or less, as a way of helping them to cope when they experience difficult emotions.

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Into the unknown: How quickly can vaccines be developed for Disease X

Pharmaceutical Technology

R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.

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Eli Lilly’s once-weekly insulin shows promise in phase 3 trials

Pharma Times

New treatment could simplify diabetes management for millions

Insulin 128
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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

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.

Drugs 125
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Can the Fed’s rate cut change biotech’s ‘new normal’?

Bio Pharma Dive

Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.

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September 30, 2024: New Guide From NIH Collaboratory Promotes Health Equity in Pragmatic Clinical Trials

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory’s Health Equity Core released a new Health Equity in Pragmatic Clinical Trials guide designed to help research teams define health equity and provide examples of how to promote it in clinical research. “Understanding what we mean by health equity is a fundamental step for integrating a health equity lens into research,” said Rosa Gonzalez-Guarda, cochair of the Health Equity Core and an associate professor and assistant dean in the Duke Un

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Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 223
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After the Lykos debacle, what’s next for psychedelic therapies?

Pharmaceutical Technology

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

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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