November, 2022

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Long-COVID personalized medicine enters Phase 2 trial

BioPharma Reporter

GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.

Trials 144
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Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy

Fierce Pharma

Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy. ntaylor. Mon, 11/28/2022 - 10:11.

Trials 119
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AI will continue to attract investment in near future in the healthcare industry

Pharmaceutical Technology

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

Big Data 363
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FDA approves first gene therapy for hemophilia B

Bio Pharma Dive

The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.

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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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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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NYC Mayor Adams faces backlash for move to involuntarily hospitalize homeless people

NPR Health - Shots

Mayor Eric Adams announced this week that officials will begin hospitalizing more homeless people by involuntarily providing care to those deemed to be in "psychiatric crisis." (Image credit: Michael M.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

Antibody 362
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Building a biotech in a downturn: 3 lessons from VCs and startup CEOs

Bio Pharma Dive

In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.

Marketing 362
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Scientists Discover X Chromosomes Being ‘Silenced’ in Male Cancer Cells

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists from the Dana-Farber Cancer Institute have found some male cancer cells, those with X and Y chromosomes, show signs of having their X chromosome silenced. In normal mammal cells, the X chromosome is only muted when a female cell has a pair of Xs to choose from. Randomly turning off an extra X is […].

Scientist 246
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Raters & Therapists: Protecting the validity of your study’s data in a psychedelic trial

Worldwide Clinical Trials

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

Trials 147
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Opinion: A tripledemic hurricane is making landfall. We need masks, not just tent hospitals

STAT News

A viral hurricane is making landfall on health care systems battered by three pandemic years. With the official start of winter still weeks away, pediatric hospitals are facing crushing caseloads of children sick with RSV and other viral illnesses. Schools that promised a “return to normal” now report widespread absences and even closures from RSV and flu in many parts of the country , contributing to parents missing work in record numbers.

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Twitter will no longer enforce its COVID misinformation policy

NPR Health - Shots

Public health experts and social media researchers are concerned that the change could have serious consequences if it discourages vaccination and other efforts to combat the still-spreading virus.

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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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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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What to make of Eisai and Biogen’s latest Alzheimer’s drug data

Bio Pharma Dive

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

Doctors 359
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The Most Common Pain Relief Drug in The World Induces Risky Behavior, Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

One of the most consumed drugs in the US – and the most commonly taken analgesic worldwide – could do a lot more than simply take the edge off your headache. Acetaminophen, also known as paracetamol and sold widely under the brand names Tylenol and Panadol, also increases risk-taking, according to a study from 2020 […].

Drugs 245
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Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial

BioPharma Reporter

A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.

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Bacteria that break down nicotine found in the guts of mice

Medical Xpress

A team of researchers affiliated with multiple institutions in China, working with a colleague in the U.S., has isolated a type of bacteria in the guts of mice that break down nicotine. In their paper published in the journal Nature, the group describes how they isolated the bacteria and why their finding could reduce incidences of fatty liver disease in humans.

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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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How monoclonal antibodies lost the fight with new COVID variants

NPR Health - Shots

The treatments were highly popular earlier in the pandemic. One by one, they got knocked out by more convenient, less expensive treatment options, and new COVID variants.

Antibody 145
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NHS expedites rollout of Bayer’s darolutamide for prostate cancer

Pharmaceutical Technology

The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.

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Narcan developer to be acquired by Indivior

Bio Pharma Dive

The deal, which could carry a total value of roughly $145 million, is in large part focused on a nasal formulation of the opioid overdose drug nalmefene.

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Teens’ Brains Develop Differently Depending on if They’re Night Owls or Early Birds

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s 11 pm on a weeknight and your teenager still has their bedroom light on. You want them to get enough sleep for school the next day, but it’s a struggle. Our new research shows what happens to the brains and behavior of young teenagers, years after they’ve become “night owls” We found this shift […].

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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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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

STAT News

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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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.

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Carrying out executions took a secret toll on workers — then changed their politics

NPR Health - Shots

NPR spoke with 26 people who were involved with more than 200 executions across the country. Most said their health suffered and they had little support to help them cope with their unusual jobs.

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Pfizer records 6% decline in revenue in Q3 2022

Pharmaceutical Technology

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

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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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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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The Cause of Alzheimer’s Could Be Coming From Inside Your Mouth

AuroBlog - Aurous Healthcare Clinical Trials blog

In recent years, a growing number of scientific studies have backed an alarming hypothesis: Alzheimer’s disease isn’t just a disease, it’s an infection. While the exact mechanisms of this infection are something researchers are still trying to isolate, numerous studies suggest the deadly spread of Alzheimer’s goes way beyond what we used to think.

Research 244
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Holmes gets more than 11 years in prison for Theranos scam

STAT News

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

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Wireless smart bandage provides new insights on healing chronic wounds

Medical Xpress

Some wounds just won't heal. Infections, diseases like diabetes, and suppressed immune systems often stack up to slow healing. Chronic wounds can last months and lead to anxiety and depression. In the worst cases, they are life threatening. Cost of treatment has soared to $25 billion each year.

Research 143
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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