Bio Pharma Dive
MARCH 30, 2023
The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.
Pharmaceutical Technology
MARCH 31, 2023
The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
NPR Health - Shots
MARCH 30, 2023
The first of its kind in the country, the Idaho legislature has passed a bill allowing criminal charges for those who help a minor get an abortion out of state. The bill now goes to Gov. Brad Little.
STAT News
MARCH 30, 2023
New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?
Bio Pharma Dive
MARCH 27, 2023
A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.
Pharmaceutical Technology
MARCH 28, 2023
Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
MARCH 29, 2023
The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.
Bio Pharma Dive
MARCH 27, 2023
The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.
Pharmaceutical Technology
MARCH 31, 2023
Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually.
NPR Health - Shots
MARCH 25, 2023
A decade after a landmark report on Americans' shorter lives, the problem has only gotten worse. Unlike other wealthy nations, U.S. life expectancy has not bounced back from the pandemic.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Medical Xpress
MARCH 30, 2023
Efforts to encourage vaccination might do well to take advantage of the positive feelings and actions between different social groups, according to a study of attitudes toward vaccines among supporters of the Black Lives Matter movement.
Bio Pharma Dive
MARCH 31, 2023
After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.
Pharmaceutical Technology
MARCH 29, 2023
Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.
NPR Health - Shots
MARCH 31, 2023
The first outbreak this year was in Equatorial Guinea, which has seen 20 deaths already. Now there are cases reported in Tanzania as well for this infectious disease with a high fatality rate.
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.
STAT News
MARCH 28, 2023
A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba
Bio Pharma Dive
MARCH 28, 2023
The biotech will work with Sonoma, a well-funded startup run by prominent immunologist Jeffrey Bluestone, to develop cell-based medicines for ulcerative colitis and Crohn’s disease.
Pharmaceutical Technology
MARCH 27, 2023
Regenerative medicines in early-stage development (preclinical, discovery, or investigational new drug [IND]/ clinical trial application [CTA] filed status) have seen a change in drug targets compared to therapies in late-stage development (Phase II to pre-registration stage). According to GlobalData’s Drugs database, early-stage therapies are focused on vascular endothelial growth factor (VEGF) as the top drug target, with three drugs currently in development.
Medical Xpress
MARCH 27, 2023
Most of the time, viruses leave our bodies as quickly as they arrived. After we suffer a week or two of fever, muscle aches, and other indignities, a surge of antibodies sends the miniature invader on its way. Case closed.
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.
STAT News
MARCH 28, 2023
In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc
Bio Pharma Dive
MARCH 27, 2023
Analysts had speculated Pfizer might divest its Bavencio interest to help close its Seagen buyout. A Pfizer spokesperson said the move was “conceived independently” of any other deal, however.
Pharmaceutical Technology
MARCH 29, 2023
Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. The partnership will combine the VelociSuite technologies of Regeneron with Sonoma Biotherapeutics’ pioneering approach to develop and produce gene modified Treg cell therapies.
Medical Xpress
MARCH 28, 2023
Researchers have evaluated the Assessment of Burden of Chronic Conditions (ABCC) scale, which was developed to improve care by facilitating shared decision making and self-management. The scale assesses and visualizes the patient's experience of one or multiple chronic conditions, and integrates it in daily care. The researchers determined it is valid and reliable in people with Chronic Obstructive Pulmonary Disease (COPD), asthma or type 2 Diabetes Mellitus (T2DM).
Advertisement
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
STAT News
MARCH 29, 2023
A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring.
Bio Pharma Dive
MARCH 27, 2023
The former venture arm of GSK had several of its portfolio companies get acquired or go public in the past year, overcoming a tough environment for young biotechs.
Pharmaceutical Technology
MARCH 28, 2023
Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D). Under the terms of the deal, the company will receive non-exclusive rights to CRISPR/Cas9, a gene-editing technology of CRISPR Therapeutics, for the development of potentially curative T1D cell therapies.
NPR Health - Shots
MARCH 30, 2023
Built largely with Western donations, the spa-like retreat provides soldiers with counseling, aromatherapy and more. But most soldiers are there for no more than a week.
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.
STAT News
MARCH 29, 2023
Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid , lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan.
Bio Pharma Dive
MARCH 27, 2023
Vertex will license CRISPR technology to develop insulin-producing islet cells that are more resistant to immune rejection, adding to other efforts directed at Type 1 diabetes.
Medical Xpress
MARCH 29, 2023
"Go outside and play" is the time-tested strategy for generations of parents and caregivers ready to see their little ones tuckered out by exercise. But the strategy may be losing some of its impact as more children face more hot days, according to new research from The University of Texas at Austin. A team found that, as the weather gets hotter, preschool-aged children become more sedentary.
NPR Health - Shots
MARCH 29, 2023
The Food and Drug Administration appears poised to make available the COVID-19 vaccines that target omicron as a second booster for people with weak immune systems and those ages 65 and older.
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.
Expert insights. Personalized for you.
326 
Let's personalize your content