June, 2023

article thumbnail

WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

article thumbnail

J&J sees trial data supporting earlier CAR-T use in multiple myeloma

Bio Pharma Dive

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

Trials 351
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Invasive Bacteria May Trigger Endometriosis, Study Suggests

AuroBlog - Aurous Healthcare Clinical Trials blog

A type of bacteria commonly found in human oral and gut flora could play a major role in the development of endometriosis, scientists have discovered – potentially giving us crucial insight into the development of the painful condition, and opening up new ways to treat it.

Bacteria 246
article thumbnail

Eisai, Biogen's Alzheimer's disease drug Leqembi passes muster at FDA adcomm

Fierce Pharma

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

Drugs 144
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Rethinking Clinical Trials

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster. ” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

article thumbnail

Why Should I Seek an Emergency Dentist?

Pharma Mirror

A bright smile is said to be the best compliment one can hear from others, and the heart of preserving and sweetening those smiles lies in a dentist’s hand. Dentistry, the art, and science of oral health, confines a diverse range of practices and professionals committed to maintaining the well-being of your teeth, gums, and overall oral health.

130
130

More Trending

article thumbnail

BioMarin finally secures FDA approval of hemophilia gene therapy

Bio Pharma Dive

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

article thumbnail

Scientists Just Figured Out How This Deadly Superbug Hides Inside Us

AuroBlog - Aurous Healthcare Clinical Trials blog

Golden staph are ubiquitous bacteria, living harmlessly on the skin or inside the nose of nearly one in three people worldwide. Yet they are duplicitous, too. In some situations, golden staph (Staphylococcus aureus) can become monsters, causing dangerous infections in the skin, blood, bones, or elsewhere.

Scientist 245
article thumbnail

BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Fierce Pharma

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

article thumbnail

June 29, 2023: Grand Rounds Podcast with Dr. Joshua Denny on All of Us Research Program is Available

Rethinking Clinical Trials

In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine. The full May 5 Grand Rounds webinar with Dr. Denny is also available. The post June 29, 2023: Grand Rounds Podcast with Dr.

Research 130
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Transforming Digital Experiences: Viseven and SpotMe Form Strategic Partnership

Pharma Mirror

LAUSANNE, Switzerland – Viseven, a leading global MarTech services provider for the Pharma and Life Sciences industries, is thrilled to announce its partnership with SpotMe, an enterprise event platform tailored to high-touch industries. This collaboration marks a significant milestone in digital communication within the healthcare industry. Driving Success in Pharma Communication The partnership between Viseven and SpotMe creates a unique point of view on the HCP engagement and B2B event organi

article thumbnail

NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

Drugs 321
article thumbnail

First Duchenne gene therapy approved by FDA for young children

Bio Pharma Dive

The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.

article thumbnail

Dr K Sujith Kumar appointed as new drug controller-in-charge in Kerala

AuroBlog - Aurous Healthcare Clinical Trials blog

Dr K Sujith Kumar, the senior deputy drugs controller (DDC) at the department of drugs control administration (DCA) in Kerala has been appointed as the drug controller-in-charge of the state from Thursday, June, 1. A Ph D holder in Pharmaceutical Regulatory Affairs (PRA) from the JSS University in Mysore, Dr.

Drugs 245
article thumbnail

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

article thumbnail

AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert

Fierce Pharma

AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.

141
141
article thumbnail

June 29, 2023: Health Equity Core Leaders Share Insights From Annual Steering Committee Meeting

Rethinking Clinical Trials

Rosa Gonzalez-Guarda and Cherise Harrington In an interview during the Annual Steering Committee Meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group , shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory. One question discussed at the meeting was how to embed health equity in pragmatic clinical trials.

article thumbnail

How to Leverage Omnichannel & Sales Enablement Technologies for Pharmaceutical Sales Success

Pharma Mirror

In the fast-paced, highly competitive pharmaceutical industry, sales reps must adapt to new ways of engaging with customers and healthcare professionals (HCPs). Two such approaches are through the use of omnichannel and sales enablement technologies, which can revolutionize the way pharmaceutical companies develop their sales force and interact with their stakeholders.

Sales 130
article thumbnail

Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Pharmaceutical Technology

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

Research 299
article thumbnail

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.

article thumbnail

After years of disappointment, cancer vaccines show new promise

Bio Pharma Dive

Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.

article thumbnail

We’re a Step Closer to Stopping a Parasite From Inflicting ‘Sleeping Sickness’

AuroBlog - Aurous Healthcare Clinical Trials blog

It starts with an innocent bite from a tsetse fly – an all too common occurrence in sub-Saharan Africa. Before a person knows it, tiny microscopic parasites known as Trypanosoma are swimming in their bloodstream, playing “hide and seek” with their immune system.

article thumbnail

Bayer needs 'midsize acquisition' to reach $10B oncology sales goal, exec says

Fierce Pharma

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

Sales 141
article thumbnail

June 28, 2023: In This Week’s PCT Grand Rounds, What’s Left for Decentralized Clinical Trials?

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez, Pamela Tenaerts, and Craig Lipset will present “Decentralized Trials – From Guidance to Reality & What’s Left.” The Grand Rounds session will be held on Friday, June 30, 2023, at 1:00 pm eastern. Dr. Hernandez is a professor of medicine and director of the Duke Clinical Research Institute at Duke University; he is a co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center.

article thumbnail

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.

article thumbnail

UNESCO backs plans for centres for excellence in pharmacy education across the world regions 

Pharma Mirror

The Hague — Plans to develop FIP-UNESCO UNITWIN centres for excellence for pharmacy education across the world have been bolstered by a renewed agreement between the International Pharmaceutical Federation (FIP) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) concerning the UNITWIN Network on Global Pharmacy Education Development, the federation announced today.

Pharmacy 130
article thumbnail

Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

290
290
article thumbnail

FDA sets decision dates for Vertex, CRISPR gene editing drug

Bio Pharma Dive

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

article thumbnail

Why Figuring Out if It’s Anxiety, ADHD, or Both Matters

AuroBlog - Aurous Healthcare Clinical Trials blog

“Cassie” is an anxious adult. She stresses and puts off tasks that should be simple. Seeing others succeed makes her feel inadequate. It’s easier to avoid challenges than risk failing again. She has taken anxiety medication, but it didn’t help much. This hypothetical example illustrates a situation many people have faced.

article thumbnail

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.

article thumbnail

Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Fierce Pharma

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

141
141
article thumbnail

Grand Rounds June 23, 2023: Improving Delivery of Care for Chronic Kidney Disease, Diabetes and Hypertension (Miguel A. Vazquez, MD and George Oliver, MD, PhD)

Rethinking Clinical Trials

Miguel A. Vazquez, MD and George Oliver, MD, PhD presented at the NIH Pragmatic Trials Collaboratory Grand Rounds on June 23, 2023. They presented on the topic of Improving Delivery of Care for Chronic Kidney Disease, Diabetes in Hypertension. Slides and recording from the presentation will be posted at a future date pending publication of a journal article.

article thumbnail

I Holland Introduce Versatool Value, an Affordable Storage Solution to Help Keep Tablet Tooling in Optimal Condition

Pharma Mirror

Maintaining optimal tablet tooling is paramount for achieving effective production outcomes. Inadequate handling and aftercare methods are responsible for 85% of punch and die problems. To address this critical issue, I Holland, leader in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has developed Safestore and tool tray racking, an innovative system designed to securely store tooling.

article thumbnail

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

Genetics 279
article thumbnail

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