Tue.Mar 21, 2023

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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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A biotech stumbles in its bid to challenge Novo’s obesity drug

Bio Pharma Dive

Altimmune’s drug aided weight loss in a Phase 2 trial, but also came with side effects that could hamper its ability to compete with Novo Nordisk’s Wegovy.

Drugs 208
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Cannabidiol milling: Selecting the right equipment for CBD testing

Pharmaceutical Technology

Cannabidiol is the second most prevalent active ingredient in cannabis (marijuana) and for medical purposes it is derived directly from the hemp plant (which is closely related to marijuana) or made in a laboratory. So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i].

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Gilead’s Yescarta extends survival in lymphoma study

Bio Pharma Dive

The results, the first for a CAR-T therapy, are further evidence supporting the use of the complex therapies earlier in a patient’s disease course.

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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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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

The biotech industry is currently undergoing a wider financial upheaval after the collapse of Silicon Valley Bank (SVB) , which was favoured by many biotech companies. In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs).

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PCI to extend approval for existing courses for the academic year 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has decided to extend the approval of existing courses for the academic year 2023-24 for the institutions which are approved by the Council, in the larger interest of the students and to maintain the timeline for the academic session.

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More Trending

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Opinion: Americans should be able to register to vote when they apply for health insurance on HealthCare.gov

STAT News

The last time you renewed your driver’s license, you likely had the opportunity to register to vote at the same time. As former administrators at the Centers for Medicare & Medicaid Services in the Department of Health & Human Services, we believe Americans should have a similarly frictionless opportunity for voter registration when they submit an application for health insurance on HealthCare.gov, the federal government’s online health insurance marketplace.

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Gilead Sciences to exclusively license Nurix Therapeutics’ protein degrader

Pharmaceutical Technology

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. The potent, selective, oral IRAK4 degrader named GS-6791 targets the scaffold and kinase functions of the IRAK4 protein kinase for blocking the pro-inflammatory IL1 cytokine family of receptors (IL1Rs) and inflammatory responses downstream of toll-like receptors (TLR).

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Private opulence, public squalor: How the U.S. helps the rich and hurts the poor

NPR Health - Shots

Poverty, by America author Matthew Desmond says if the top 1% of Americans paid the taxes they owed, it would raise $175 billion each year: "That is just about enough to pull everyone out of poverty.

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Tanzania reports a Marburg outbreak, Africa’s second this year

STAT News

Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.

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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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FDA gives 2nd safety nod to cultivated meat, produced without slaughtering animals

NPR Health - Shots

GOOD Meat, which grows chicken and other meat from animal cells in a production facility, is the second company to cross this hurdle. The move brings no-kill meat closer to sale in the U.S. (Image credit: Brian L. Frank for NPR/Brian L.

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Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

                                           Speaker Ethan Basch, MD, MSc Richard M. Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care.

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What to know about xylazine, the drug authorities are calling a public safety threat

NPR Health - Shots

The veterinary tranquilizer has been linked to a growing number of overdose deaths across the country, especially in the Northeast. It's often combined with fentanyl, but can't be treated with Narcan.

Drugs 133
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Study finds same small rise in breast cancer risk in many forms of hormonal birth control

STAT News

Pills, patches, implants, and injections — the various forms of hormonal birth control have different formulations and doses of estrogen, progestin, or both. One might think, then, that they may have an unequal influence on breast cancer risk, but a new study in PLOS Medicine on Tuesday suggests that’s not so. The analysis found that most forms of hormonal birth control, regardless of their formulation, seem to confer roughly the same, small increase to breast cancer risk.

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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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Medicaid renewals are starting. Those who don't reenroll could get kicked off

NPR Health - Shots

With a pandemic-era rule expiring this month, people on Medicaid will have to re-qualify to keep their coverage. Language barriers, housing instability and computer literacy could stand in their way.

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STAT+: A new Medicare ruling could give virtual reality companies an easier path to payment

STAT News

The path to payment for virtual reality companies working in health care just became slightly smoother. AppliedVR, a company targeting chronic pain, has become the first digital therapeutic to find an easy way to secure reimbursement from the Centers for Medicare and Medicaid Services. CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment.

Drugs 119
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Smartphone games can help to detect the long-lasting effects of traumatic brain injuries

Medical Xpress

New research from the University of Hertfordshire has found that a mobile-phone game app can help identify ongoing problems with navigation—a common long-term symptom of traumatic brain injuries (TBIs)—making these issues easier to diagnose and treat.

Research 105
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Opinion: The lab leak conversation shows it’s time to rethink our biosecurity infrastructure, not just policies

STAT News

The Covid pandemic exacerbated fear and panic regarding the potential for a future bioterrorism agent. As the lab leak theory continues to cause debate, politicians want to be able to tell their constituents that they are solving the problem by adding more oversight to biological research. But if all they are doing is adding more burden, bureaucracy, and box-checking, is it really making anyone more secure?

Research 119
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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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Waist-to-height ratio, not BMI, accurately indicates outcomes in patients with heart failure, says study

Medical Xpress

New research has debunked the idea that there is an "obesity paradox," whereby patients with heart failure who are overweight or obese are thought to be less likely to end up in hospital or die than people of normal weight.

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Methadone doses haven’t kept up in the age of fentanyl. A new rule aims to help

STAT News

Patients beginning treatment for opioid addiction often face excruciating withdrawal symptoms. But for people struggling to transition from ultra-potent illicit fentanyl to comparatively weaker addiction medications, help may be on the way. A new federal regulation would make it easier for some patients to begin treatment on significantly higher doses of methadone , a key medicine used to treat opioid use disorder.

Medicine 105
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For clues to healthy brain aging, look to the Bolivian Amazon

Medical Xpress

Some of the lowest rates of heart and brain disease ever reported by science are found among Indigenous communities inhabiting the tropical forests of lowland Bolivia. New USC research on two of these societies, the Tsimané and Mosetén, suggests that there are optimal levels of food consumption and exercise that maximize healthy brain aging and reduce the risk of disease.

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STAT+: Patient groups balk at former AstraZeneca official negotiating U.K.-India free trade deal

STAT News

More than 200 civil society and patient advocacy groups are urging the U.K. government to remove the key negotiator working on a free trade agreement with the Indian government because of his previous ties to a major pharmaceutical company. A leaked version of the agreement already sparked concerns last year that the proposed deal would impede the supply of affordable generic medicines in poor countries around the world.

Medicine 105
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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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Cannabis use in adolescent years may create reproductive complications in women, according to new study

Medical Xpress

In a new study, University of California, Irvine researchers found that exposure to the compound tetrahydrocannabinol (THC, a component of cannabis) at a young age could lead to depleted ovarian follicles and matured eggs in adulthood by nearly 50 percent.

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STAT+: 8 burning questions Bernie Sanders and other senators should ask Moderna’s Stéphane Bancel

STAT News

WASHINGTON — Moderna CEO Stéphane Bancel has some explaining to do. Bancel will appear alone before Sen. Bernie Sanders’ health committee on Wednesday, where he’ll have to defend his company’s suggestion it will likely quadruple the price of its Covid vaccines once sales transition from bulk federal purchases to the open market.

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Researchers identify new genes that modulate the toxicity of the protein ?-amyloid, responsible for causing Alzheimer's

Medical Xpress

An international study led by the Molecular Physiology Laboratory at the UPF Department of Medicine and Life Sciences (MELIS) identifies new genes that modulate the toxicity of the protein β-amyloid, responsible for causing Alzheimer's disease.

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Have you had difficulty getting access to medications for opioid addiction?

STAT News

STAT is reporting on the obstacles that prevent many Americans from accessing methadone and buprenorphine , two key medications used to treat opioid use disorder. People and organizations that sometimes make it difficult to access medication can include doctors, methadone clinics, health insurance companies, recovery groups, law enforcement agencies, jails, prisons, drug courts, and labor unions.

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Biden signs bill on COVID origins declassification

Medical Xpress

President Joe Biden signed a bipartisan bill Monday that directs the federal government to declassify as much intelligence as possible about the origins of COVID-19 more than three years after the start of the pandemic.

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Steroid drug reduces death rate in severe pneumonia, study shows

STAT News

Giving doses of the steroid hydrocortisone to patients with severe pneumonia cut the risk of death by about half, according to a study released Tuesday. In the study, researchers funded by the French Ministry of Health randomly assigned 800 patients who had been placed in the intensive care unit to receive either hydrocortisone or a placebo. In the hydrocortisone group, about 6% of patients died within 28 days.

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Research reveals substantial human cost of international COVID-19 travel and border restrictions

Medical Xpress

New research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (April 15-18) reveals the high human costs and negative impacts of border restrictions and travel bans during the COVID-19 pandemic on citizens stranded abroad.

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STAT+: Altimmune’s obesity drug fails to stand out from blockbuster treatments in early data

STAT News

A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market. The drug, called pemvidutide, is part of a growing class of medications that target the GLP-1 receptor, mimicking the effects of a hormone that can help people feel full.

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Alcohol abuse and anxiety sensitivity are linked in different but mutually reinforcing ways, finds study

Medical Xpress

Anxiety sensitivity—the fear of anxiety-related sensations—has a long and not very healthy relationship with alcohol use and abuse. People who display high levels of AS are more likely to drink heavily and use alcohol as a coping method or to reduce tensions. For young adults, who drink the most, high AS can put them at risk for drinking to cope, which poses risks for long-term consequences on their personal and professional lives, including underemployment and addiction.

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STAT+: Pharmalittle: FDA official wants to use accelerated approval for gene therapies; pharma asks Biden for tax breaks in the semiconductor package

STAT News

Top of the morning to you, and a fine one it is. A bright, shiny sun and clear blue skies are hovering over the Pharmalot campus, where the short person is sleeping in and the official mascot is bounding about in search of furry creatures. As for us, we are following our usual routine of brewing cups of stimulation — our choice today is maple bourbon — and foraging for items of interest.