Sat.Apr 15, 2023 - Fri.Apr 21, 2023

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Post-COVID-19 cognitive impairment: a new target for drug development?

Drug Discovery World

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. We are amidst a shift of focus from dealing with the acute impacts of the Covid-19 pandemic to tackling the ‘long Covid-19’ symptoms that may now represent greater future challenges for healthcare systems and patient quality of life.

Drugs 98
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US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5 strains can now be utilised for all doses administered to those aged six months and above.

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Merck to buy inflammatory disease drugmaker Prometheus for $10.8B

Bio Pharma Dive

The pharma has struck the sector’s second-largest buyout this year, announcing a deal for the developer of an inflammatory bowel disease treatment that’s shown promise in testing.

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New injectable cell therapy could resolve osteoarthritis

Medical Xpress

Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage.

Medicine 145
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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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Tired of ‘dead end’ approach, herpes patients mobilize to demand government action

STAT News

A medical student spoke emotionally about grappling with a diagnosis his classes told him little about. A young queer man took one test, got a different result on the next, and is now saving up the money needed for the most advanced diagnostics, which insurers rarely cover. A young woman tested positive, got little guidance from her doctor and found information on government sites that she interpreted as pushing abstinence.

Doctors 145
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Twist Bioscience and Astellas team up for antibody discovery

Pharmaceutical Technology

Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. This is the third collaboration between the two companies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.

Antibody 264

More Trending

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As pandemic emergencies end, some patients with long COVID feel 'swept under the rug'

NPR Health - Shots

Millions of Americans suffer from long COVID, which can have debilitating physical effects, including fatigue and difficulty breathing. Yet many patients feel abandoned, as federal aid winds down.

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The NIH has poured $1 billion into long Covid research — with little to show for it

STAT News

WASHINGTON — The federal government has burned through more than $1 billion to study long Covid , an effort to help the millions of Americans who experience brain fog, fatigue, and other symptoms after recovering from a coronavirus infection. There’s basically nothing to show for it.

Research 145
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SAB secures FDA breakthrough therapy status for influenza immunotherapy

Pharmaceutical Technology

SAB Biotherapeutics has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for SAB-176, an investigational immunotherapy to treat influenza. The newly granted status allows SAB to speed up the development and review of SAB-176, which is currently being studied for use in post-exposure prophylaxis for Type A and Type B influenza in high-risk patients, including those with anti-viral resistant strains.

Antibody 264
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Moderna, Merck data support claim of cancer vaccine’s promise

Bio Pharma Dive

Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

RNA 345
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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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New study confirms link between 'forever chemicals' in drinking water and weight gain

Medical Xpress

A University of Rhode Island researcher has led a study that confirms a direct link between certain chemicals in drinking water and human obesity—specifically that increased PFAS content in blood promotes weight gain and makes it harder to keep a lower body weight after weight loss.

Research 145
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One reason the push for diversity in medicine is lagging

NPR Health - Shots

The U.S. desperately needs more Black and Hispanic doctors, research shows. But financial pressures and discrimination can keep young people from even applying to med school.

Medicine 144
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Merck agrees to acquire Prometheus Biosciences for $10.8bn

Pharmaceutical Technology

Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.

Antibody 262
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Startup Abdera raises $110M to fuel radiopharmaceutical research

Bio Pharma Dive

The company, which previously raised $32 million in Series A funding, joins a growing list of new startups working to develop targeted radiation treatments.

Research 309
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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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Brain images just got 64 million times sharper

Medical Xpress

Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization.

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Study: Black women should start breast cancer screening at age 42

STAT News

For many years, there’s been considerable debate about the best age for women to initiate breast cancer screening.The U.S. Preventive Services Task Force recommends that women start getting screenings around age 50, while groups such as the American Cancer Society recommend screenings begin at an earlier age. Now a large new study suggests that if Black women begin screening for breast cancer at age 42, that could help lower racial disparities in breast cancer deaths.

Research 142
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Acadia commercialises first US Rett Syndrome drug

Pharmaceutical Technology

Acadia Pharmaceuticals has announced the commercial launch of its Rett Syndrome drug Daybue (trofinetide). This news follows the treatment’s FDA approval on 10 March, making it the first-approved Rett Syndrome treatment in the US. Daybue is now available for the treatment of adults and children under two years of age or older in the US. The FDA approved the drug based on positive Phase III data from the Lavender trial.

Drugs 255
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Merck’s latest deal turns up the spotlight on immune system drugmakers

Bio Pharma Dive

The buyout of Prometheus highlights pharmaceutical companies’ intense interest in medicines targeting inflammatory diseases, according to analysts.

Medicine 304
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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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No magic number for time it takes to form habits, finds new study

Medical Xpress

Putting on your workout clothes and getting to the gym can feel like a slog at first. Eventually, you might get in the habit of going to the gym and readily pop over to your Zumba class or for a run on the treadmill. A new study from social scientists at Caltech now shows how long it takes to form the gym habit: an average of about six months.

Scientist 145
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COVID during pregnancy may alter brain development in boys

NPR Health - Shots

Boys born to mothers who got COVID-19 while pregnant seem to have a higher risk of subtle developmental delays, including those associated with autism spectrum disorder.

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Moderna and IBM to explore quantum computing and AI for mRNA research

Pharmaceutical Technology

Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.

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GSK to buy Bellus Health and its chronic cough drug for $2B

Bio Pharma Dive

The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.

Drugs 279
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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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Talking therapies linked with reduced risk of cardiovascular disease

Medical Xpress

Effective management of depression through psychological therapy is associated with a lower likelihood of heart disease and stroke, according to research published today in European Heart Journal.

Research 138
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Discrimination lawsuit against HHMI spotlights barriers faced by scientists with disabilities

STAT News

University of Michigan pediatric neurologist Vivian Cheung made a name for herself studying rare genetic diseases, and in 2008 — when she was on the faculty at the University of Pennsylvania — was hired as a Howard Hughes Medical Institute investigator, an honor for which she received $1 million a year over the next 12 years to further her research.

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Incyte receives EC approval for Opzelura to treat non-segmental vitiligo

Pharmaceutical Technology

Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.

Medicine 246
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Apellis’ immune system drug hits a setback in ALS

Bio Pharma Dive

The company has chosen to stop an extension portion of a key study after an external group of advisers reviewed the data available and concluded further treatment with the drug was unwarranted.

Drugs 241
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Why anti-abortion groups are citing the ideas of a 19th-century 'vice reformer'

NPR Health - Shots

Anthony Comstock pushed Congress to crack down on what he saw as harmful vices, such as pornography and contraception. An 1873 law named for him has appeared in recent court battles over abortion.

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Disturbed sleep may partially explain long COVID breathlessness

Medical Xpress

A major UK study has discovered that the disturbed sleep patterns in patients hospitalized with COVID-19 was likely to be a driver of breathlessness.

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FDA pushes Daiichi Sankyo’s quizartinib approval date by three months

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.

Drugs 246
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French biotech pulls EMA application for eye disease gene therapy

Bio Pharma Dive

With cash running low and a search for a buyer underway, GenSight wants advice from regulators on the type of data that would support an approval.

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13 years after bariatric surgery, a 27-year-old says it changed her life

NPR Health - Shots

Maria Caprigno was one of the youngest people in the U.S. to get the surgery. As parents and doctors grapple with the obesity treatment for teens, Caprigno cites the long-term benefits.

Doctors 132
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In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

Fierce Pharma

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35

Trials 145