Wed.Sep 21, 2022

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Alzheimer’s Might Not Actually Be a Brain Disease, Expert Says

AuroBlog - Aurous Healthcare Clinical Trials blog

The pursuit of a cure for Alzheimer’s disease is becoming an increasingly competitive and contentious quest with recent years witnessing several important controversies. In July 2022, Science magazine reported that a key 2006 research paper, published in the prestigious journal Nature, which identified a subtype of brain protein called beta-amyloid as the cause of Alzheimer’s, […].

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Industrial automation hiring levels in the pharmaceutical industry rose in August 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for industrial automation related positions rose in August 2022 compared with the equivalent month last year, with 52% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 49.7% of companies who were hiring for industrial automation related jobs a year ago but a decrease compared to the figure of 58.3% in July 2022.

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September 21, 2022: In PCT Grand Rounds, Birth Outcomes of a Nurse Home Visiting Program in a Medicaid-Eligible Population

Rethinking Clinical Trials

Dr. Margarat McConnell. In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “ Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern.

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Rocket agrees to acquire biotech firm Renovacor

Pharmaceutical Technology

Rocket Pharmaceuticals has entered a definitive agreement for the acquisition of biotechnology firm Renovacor in an all-stock equity deal worth nearly $53m, or $2.60 for each share. Renovacor focuses on offering precision treatments for genetic cardiovascular and mechanistically-related ailments. The most advanced programme of the company is adeno-associated virus (AAV)-based gene therapy, REN-001.

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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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Parliamentary Committee recommends govt to bring DoP under ministry of health

AuroBlog - Aurous Healthcare Clinical Trials blog

The department-related Parliamentary Committee for ministry of health and family welfare, which has looked into the medical devices regulations and recommended the way forward, has sought the Central government to bring the Department of Pharmaceuticals (DoP) under the Ministry, for better coordination. It has also pitched an idea of setting up a department of medical […].

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Pfizer and CytoReason extend partnership for AI-driven drug discovery

Pharmaceutical Technology

Pfizer and CytoReason have expanded their multi-year collaboration to leverage the latter’s artificial intelligence (AI) technology to discover and develop the former’s drug programmes. According to the deal, Pfizer will invest $20m in equity, hold options for licencing the platform and disease models of CytoReason, and provide additional funding for supporting supplementary projects.

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Industrial automation hiring levels in the pharmaceutical industry rose in August 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for industrial automation related positions rose in August 2022 compared with the equivalent month last year, with 52% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 49.7% of companies who were hiring for industrial automation related jobs a year ago but a decrease compared to the figure of 58.3% in July 2022.

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To stem overdoses, Canada is offering safer opioids. Advocates want the U.S. to do the same

STAT News

TORONTO — The Finks, married just a month earlier, sat down for their appointment, Kim dressed in head-to-toe pink and Chris in all black. He was taciturn, while she joked she couldn’t stop talking long enough to have her blood pressure taken. Jouvence Tshiyoyo Bukumba, a nurse, asked Kim, 46, about her cardiology appointment and Chris, 54, about his nerve pain.

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AstraZeneca’s Tezspire for severe asthma gets green light in EU

pharmaphorum

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. Tezspire (tezepelumab) has been cleared for use in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal produ

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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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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Patch vaccine innovator Vaxxas receives $8.2m grant to scale-up manufacturing facility

BioPharma Reporter

Vaxxas will receive an AU$8.2m second round grant as part of the Australian Federal Governmentâs Modern Manufacturing Initiative (MMI) to support the manufacturing scale-up of its technology that enables vaccines to be applied to the skin using a small patch.

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Opinion: Termination is the safest course for some high-risk pregnancies. Dobbs decision threatens that care

STAT News

Ava was excited about her pregnancy. As her rheumatologists, we were anxious about it. Her death left a newborn without its mother, shattered a family, and may be a harbinger of what’s to come for pregnant people with serious medical conditions. Ava (not her real name) was a 28-year-old Hispanic woman with systemic lupus erythematosus, an autoimmune disease in which the immune system mistakenly attacks the body’s tissues and organs.

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Newly discovered protein connected to Alzheimer's disease risk

Medical Xpress

A mutation in a newly discovered small protein is connected to a significant increase in the risk for Alzheimer's disease, expanding the known gene targets for the disease and presenting a new potential avenue for treatment, according to a new USC study.

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STAT+: Researchers show they can quickly turn CAR-T cells on and off, raising hopes for safer cancer treatments

STAT News

Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off in cancer patients, giving scientists an unprecedented level of control over this potent — but at times dangerous — oncology therapy. The findings, presented at the CAR-TCR Summit in Boston, come from an early-stage clinical trial by Scripps Research of patients with B cell cancers.

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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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How fear memories get stuck in some brains

Medical Xpress

Researchers at Linköping University, Sweden, have discovered a biological mechanism that increases the strength with which fear memories are stored in the brain. The study, carried out in rats, is published in Molecular Psychiatry. It provides new knowledge on the mechanisms behind anxiety-related disorders, and identifies shared mechanisms behind anxiety and alcohol dependence.

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STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

STAT News

Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized.

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Patient centricity is becoming business critical for pharma

pharmaphorum

New book sets the pharmaceutical industry on a course for bridging the patient centricity optimism gap. Bridging the gulf between patient centricity ambition and reality has never been more important for pharma – luckily, this seemingly insurmountable goal isn’t as far out of reach as many envision. That’s according to Sharon Suchotliff, patient centricity lead at consultancy firm ZS Associates, which has just published a book on the art of patient involvement.

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Rare human gene variant in ADHD, autism exposes fundamental sex differences

Medical Xpress

The prevalence, age of onset, and clinical symptoms for virtually all neuropsychiatric disorders differ between men and women. Among the disorders with pronounced sex bias are Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD), where the ratio of males/females diagnosed is approximately 4 to 1. Whether this skewed ratio arises from roles played in brain development by sex-specific DNA sequences or hormones or reflects the way that biological mechanisms and environ

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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

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Opinion: Listen: Polio is back in the U.S. Two physicians offer ways to fight its spread

STAT News

Polio has exploded back into Americans’ consciousness after being out of the spotlight in the U.S. for half a century or so: In late summer, it paralyzed an adult in New York state, and the poliovirus has been detected in New York City’s wastewater. This week on the “First Opinion Podcast,” doctors Sallie Permar and Jay Varma make the case that pediatricians are the frontline for fending off this “old foe,” but they need help.

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Diabetes and oral diseases affect each other and hinder treatment

Medical Xpress

Research shows that common chronic diseases and problems associated with oral health have a detrimental and long-term reciprocal effect on each other. To achieve the best possible treatment outcomes, the general and oral health of patients should be considered as a whole.

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STAT+: Pharmalittle: FDA scolds Catalent over quality control at plant making Covid shots; Novartis will ask SCOTUS to protect a key patent

STAT News

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple cinnamon French toast, a yummy concoction that has quickly become one of our favorites.

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Looking at images of people smiling at you extends the antidepressant effects of ketamine

Medical Xpress

Simple computer-based neurocognitive training—using positive words and pictures designed to boost self-worth—prolongs the antidepressant effects of ketamine in people with treatment-resistant depression, University of Pittsburgh researchers report today in the American Journal of Psychiatry.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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Dispelling myths about memory loss for World Alzheimer's Day

Antidote

September 21 is World Alzheimer’s Day , a day of recognition aimed at increasing awareness of and understanding the issues faced by people living with Alzheimer’s. Though there are many conditions that can cause memory loss , Alzheimer’s is one of the most common — it is estimated that 5.4 million Americans are living with the condition , most of whom are over the age of 65.

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Rising obesity projected to hamper developing economies: report

Medical Xpress

Rising levels of obesity are set to cost the world economy 3.3 percent of GDP by 2060, slowing development in lower-income countries and making it hard for people to lead healthy lives, according to a new study published Wednesday.

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FDA seems poised to approve a new drug for ALS, but does it work?

NPR Health - Shots

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

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Non-communicable diseases cause 74% of global deaths: WHO

Medical Xpress

Non-communicable diseases like heart disease, cancer and diabetes are responsible for 74 percent of deaths globally and cracking down on risk factors could save millions of lives, the WHO said Wednesday.

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Fennec finally pushes drug to prevent chemotherapy-induced hearing loss across the FDA finish line

Fierce Pharma

Fennec finally pushes drug to prevent chemotherapy-induced hearing loss across the FDA finish line. esagonowsky. Wed, 09/21/2022 - 09:58.

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Launch of global type 1 diabetes index

Medical Xpress

JDRF, a global type 1 diabetes (T1D) research and advocacy organization, announces the launch of the Type 1 Diabetes Index (T1D Index). The T1D Index is a first-of-its-kind data simulation tool that measures the human and public health impact of the T1D crisis in every country across the globe. Until now, there have been wide gaps in the data about the incidence and impact of T1D.

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13th PM Society Digital Awards – celebrating creative innovation

pharmaphorum

Although a tone of respectful sobriety lay over the PM Society Awards this year, as the nation’s citizens came from far and wide to London to pay their final respects to Her Majesty Queen Elizabeth II, Thursday 15 th September was, nonetheless, in equal measure an evening that paid serious homage to the best and brightest in creative digital innovation and its effectiveness within the healthcare arena.

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Do sleep timing and duration affect dementia risk?

Medical Xpress

New research published in the Journal of the American Geriatrics Society suggests that the time people go to bed and the amount of time they sleep may affect their risk of developing dementia.

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Lannett, Par join the list of companies struggling to supply Adderall and its generics

Fierce Pharma

Lannett, Par join the list of companies struggling to supply Adderall and its generics. zbecker. Wed, 09/21/2022 - 08:46.

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Researchers use artificial intelligence to explore cellular origins of Alzheimer's disease and other cognitive disorders

Medical Xpress

Mount Sinai researchers have used novel artificial intelligence methods to examine structural and cellular features of human brain tissues to help determine the causes of Alzheimer's disease and other related disorders. The research team found that studying the causes of cognitive impairment by using an unbiased AI-based method—as opposed to traditional markers such as amyloid plaques—revealed unexpected microscopic abnormalities that can predict the presence of cognitive impairment.