Drug Discovery World

APRIL 20, 2023

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

Drugs Clinical Trials Clinical Trials Development 98

Pharmaceutical Technology

APRIL 19, 2023

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.

Vaccination 334

Vaccination Vaccine Gene Therapy Gene 334

Bio Pharma Dive

APRIL 16, 2023

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.

Development 325

Development 325

Medical Xpress

APRIL 21, 2023

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

Medicine Scientist 145

Advertisement

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.

Clinical Trials

STAT News

APRIL 21, 2023

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

Doctors Doctor Research 145

Pharmaceutical Technology

APRIL 21, 2023

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

Antibody Protein Licensing Licensing 264

NPR Health - Shots

APRIL 19, 2023

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.

145

145

STAT News

APRIL 20, 2023

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

Research 145

Pharmaceutical Technology

APRIL 19, 2023

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

Antibody Drugs Trials Development 264

Bio Pharma Dive

APRIL 16, 2023

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

RNA 344

RNA 344

Advertisement

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

Clinical Trials

Medical Xpress

APRIL 19, 2023

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

Research 145

NPR Health - Shots

APRIL 20, 2023

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

Medicine Doctors Doctor Research 144

Pharmaceutical Technology

APRIL 17, 2023

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

Antibody Trials Medicine Engineer 262

Bio Pharma Dive

APRIL 20, 2023

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

Research Development 297

Advertisement

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.

Clinical Trials

Medical Xpress

APRIL 17, 2023

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.

145

145

STAT News

APRIL 19, 2023

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

Research 142

Pharmaceutical Technology

APRIL 18, 2023

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

Drugs FDA Approval Clinical Trials Clinical Trials 255

Bio Pharma Dive

APRIL 17, 2023

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

Medicine 293

Medicine 293

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.

Clinical Research

Medical Xpress

APRIL 17, 2023

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

Scientist 145

NPR Health - Shots

APRIL 18, 2023

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.

Development 145

Development 145

Pharmaceutical Technology

APRIL 21, 2023

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.

Gene Therapy 246

Gene Therapy Research Gene Medicine 246

Bio Pharma Dive

APRIL 18, 2023

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

Drugs Development 269

Advertiser: FourKites

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.

Research

Medical Xpress

APRIL 18, 2023

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

Research 138

STAT News

APRIL 19, 2023

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.

Genetic Disease 136

Genetic Disease Scientist Genetics Research 136

Pharmaceutical Technology

APRIL 21, 2023

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

Medicine Trials Research Development 246

Bio Pharma Dive

APRIL 21, 2023

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

Drugs 241

Advertisement

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.

Gene Therapy

NPR Health - Shots

APRIL 18, 2023

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.

136

136

Medical Xpress

APRIL 15, 2023

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.

144

144

Pharmaceutical Technology

APRIL 21, 2023

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

Drugs Medicine Trials Branding 246

Bio Pharma Dive

APRIL 21, 2023

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.

Gene Therapy 258

Gene Therapy Gene Regulation 258

Advertisement

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.

Clinical Trials