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.

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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.

Scientist 145
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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

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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 344
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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 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.

Engineer 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 297
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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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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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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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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 293
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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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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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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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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.

Research 246
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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 269
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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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.

Scientist 136
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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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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.

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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.

Branding 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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.