Sat.Nov 05, 2022 - Fri.Nov 11, 2022

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Amgen to test new way to lower heart risk with large drug trial

Bio Pharma Dive

Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).

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Cyagen and Neurophth partner to develop gene therapy vectors

Pharmaceutical Technology

Cyagen and Neurophth Therapeutics have entered a strategic partnership to jointly develop next-generation AAV gene therapy vectors for specific kinds of genetic ophthalmic ailments. According to the deal, Cyagen will leverage its artificial intelligence (AI)-driven high-throughput platform for discovering new AAV vectors with enhanced tissue targeting expertise, tissue specificity and productivity. .

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Magic Mushroom Psychedelic Relieves Severe Depression in Largest Trial Yet

AuroBlog - Aurous Healthcare Clinical Trials blog

For some years now, scientists have been investigating how psilocybin, the psychedelic compound in magic mushrooms, can ease the symptoms of depression. More evidence of the link has arrived with a phase 2, double-blind trial involving 233 participants, the largest study on this subject carried out so far in terms of sample size. The volunteers […].

Trials 263
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From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

Worldwide Clinical Trials

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

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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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Centerview grows role as go-to adviser for biopharma dealmaking

Bio Pharma Dive

Over the past several years, the investment firm has served as a financial adviser on biopharma acquisitions worth more than $200 billion in total, with the latest announced Monday.

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Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies.

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AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments

Fierce Pharma

AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.

Antibody 145
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Biogen names former Sanofi head Viehbacher to replace Vounatsos as CEO

Bio Pharma Dive

Viehbacher, who ran Sanofi from 2008 to 2014, will take over as CEO on Nov. 14, more than six months after Biogen began its search for a new leader.

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EC grants approval for Sanofi-GSK’s Covid-19 booster

Pharmaceutical Technology

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.

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This Single Blood Test Can Detect Multiple Kinds of Cancer Early

AuroBlog - Aurous Healthcare Clinical Trials blog

Detecting cancer early before it spreads throughout the body can be lifesaving. This is why doctors recommend regular screening for several common cancer types, using a variety of methods. Colonoscopies, for example, screen for colon cancer, while mammograms screen for breast cancer. While important, getting all these tests done can be logistically challenging, expensive, and […].

Doctor 244
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Meditation works as well as a popular drug to reduce anxiety, study finds

NPR Health - Shots

Researchers compared a practice of daily mindfulness meditation to taking Lexapro to control anxiety symptoms. The meditators got equivalent relief, without the side effects.

Drugs 145
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Early data hint at benefit for Amgen’s obesity drug

Bio Pharma Dive

Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

Drugs 340
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NKGen and Parkinson’s Foundation partner to advance cell therapy

Pharmaceutical Technology

NKGen Biotech and the Parkinson’s Foundation have entered a partnership to progress the former’s new natural killer (NK) cell therapy development for advanced Parkinson’s disease (PD). The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network.

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Expert Explains How Opioids Caused a Celebrity’s Gut to Burst

AuroBlog - Aurous Healthcare Clinical Trials blog

In his new autobiography, Matthew Perry reveals that his colon burst as a result of his addiction to opioid painkillers. The 53-year-old actor, who played Chandler Bing in Friends, was in a coma for two weeks following the incident and had to wear a colostomy bag for nine months. Many people take prescription opioids, such […].

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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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New VA study finds Paxlovid may cut the risk of long COVID

NPR Health - Shots

For those at high risk, Pfizer's antiviral drug helps stave off severe COVID-19. Now research suggests it may also reduce their chances of long COVID.

Drugs 145
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Novavax details trial results for omicron-targeting booster shots

Bio Pharma Dive

A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.

Antibody 327
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AstraZeneca reports 9% rise in Q3 2022 total revenue

Pharmaceutical Technology

AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.

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Care-Keralam plans multi-pronged strategy to boost Ayush SMEs with special focus on marketing companies

AuroBlog - Aurous Healthcare Clinical Trials blog

The Ayush cluster in Kerala, Care-Keralam Ayurvedic Resource Centre at Koratty in Thrissur, is planning to adopt a multi-pronged strategy to support the small and medium ayurvedic drug manufacturing enterprises (SMEs) by focusing on their production growth and marketing of products. Similar support will be provided to other streams of the Ayush like Siddha and […].

Marketing 187
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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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More older Americans become homeless as inflation rises and housing costs spike

NPR Health - Shots

In Montana and across the nation, homeless shelters report the worrisome trend that seniors are a growing proportion of their residents.

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Pharma earnings outline drug law’s looming impact on sales, development

Bio Pharma Dive

While many companies are still unsure of the Inflation Reduction Act's effects, some have begun to warn investors about the likelihood of lower sales and reduced profitability.

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The pharmaceutical industry found it easier to fill artificial intelligence vacancies in Q3 2022

Pharmaceutical Technology

Artificial intelligence related jobs that were closed during Q3 2022 had been online for an average of 36.5 days when they were taken offline. This was a decrease compared to the equivalent figure a year earlier, indicating that the required skillset for these roles has become easier to find in the past year. Artificial intelligence is one of the topics that GlobalData, our parent company and from whom the data for this article is taken, have identified as being a key disruptive technology force

Marketing 211
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AI-enabled devices and technologies will improve patient care in India: GlobalData

AuroBlog - Aurous Healthcare Clinical Trials blog

Major healthcare and technology companies are looking at exploring the market for artificial intelligence (AI) enabled devices and technologies in the healthcare market in India, according to experts. With the rise of AI and machine learning-focused healthtech startups in India, big companies are looking for opportunities to invest and expand their footprint in the country […].

Marketing 187
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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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How a team of Black paramedics set the gold standard for emergency medical response

NPR Health - Shots

In American Sirens, writer Kevin Hazzard recounts how a group of Black paramedics in Pittsburgh in the 1970s pioneered and professionalized the modern day ambulance service.

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FDA halts Verve plans to test gene editing therapy for heart disease in US

Bio Pharma Dive

Verve didn’t say what led to the FDA’s decision, but claimed it hasn’t observed any safety issues in an ongoing trial in New Zealand and the U.K, where enrollment will continue.

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Artificial intelligence hiring levels in the pharma industry dropped in October 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for artificial intelligence related positions dropped in October 2022 compared with the equivalent month last year, with 37.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was lower than the 38.6% of companies who were hiring for artificial intelligence related jobs a year ago and a decrease compared to the figure of 39.8% in September 2022.

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NIMHANS works to end stigma around mental healthcare, highlights early detection for faster treatment access

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institute of Mental Health and Neuro Sciences (NIMHANS) is concerned about the poor mental literacy levels and is working to reduce stigma around it. This could enable people to access care without any hesitation. The Institute sees stigma and discrimination as a major constraint to access mental healthcare. Worldwide it is reported that […].

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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New omicron subvariants now dominant in the U.S., raising fears of a winter surge

NPR Health - Shots

Step aside, BA.5. The new variants BQ.1 and BQ.1.1, appear to be among the most adept yet at evading immunity from previous infection and vaccination.

Vaccine 141
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Arrowhead capitalizes on Amgen drug progress with royalty rights deal

Bio Pharma Dive

The biotech will sell its royalty interest in a heart disease drug Amgen is developing for $250 million, extending its operating runway by several quarters.

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FDA grants EUA for Sobi’s Covid-19 treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. Kineret is indicated for such patients needing supplemental oxygen and are at increased risk of advancing to severe respiratory failure.

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ICMR to promote research into stillbirths to reduce it to single digits by 2030

AuroBlog - Aurous Healthcare Clinical Trials blog

In a bid to bring down stillbirths to single digits by 2030, the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has taken an initiative to encourage collaborative, multi-center/multi-institutional interdisciplinary research to investigate and examine the issue of stillbirths and find appropriate antenatal […].

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The New Age of Decentralized Clinical Trials

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.