Pharmaceutical Technology
JUNE 20, 2023
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.
Bio Pharma Dive
JUNE 5, 2023
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.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 28, 2023
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.
Pharma Times
JUNE 21, 2023
Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Fierce Pharma
JUNE 9, 2023
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.
Rethinking Clinical Trials
JUNE 29, 2023
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 29, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2023
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.
Pharma Mirror
JUNE 29, 2023
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.
Fierce Pharma
JUNE 12, 2023
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.
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
Rethinking Clinical Trials
JUNE 29, 2023
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.
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
Bio Pharma Dive
JUNE 22, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2023
“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.
Pharma Mirror
JUNE 23, 2023
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
Bio Pharma Dive
JUNE 8, 2023
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.
Bio Pharma Dive
JUNE 9, 2023
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.
Bio Pharma Dive
JUNE 15, 2023
Lilly will pay the genetic medicine specialist $60 million upfront to work together on a treatment targeting a risk factor known as Lp(a).
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
JUNE 9, 2023
In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.
Bio Pharma Dive
JUNE 21, 2023
While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.
Bio Pharma Dive
JUNE 1, 2023
The biotech will price its biosimilar Yusimry at 85% below Humira’s list price when it launches next month, and charge even less if bought through Mark Cuban’s pharmacy.
Bio Pharma Dive
JUNE 22, 2023
The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.
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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.
Bio Pharma Dive
JUNE 2, 2023
Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.
Bio Pharma Dive
JUNE 9, 2023
CMS named 43 Part B drugs for which prices rose more than inflation, and which will have lower coinsurance rates next quarter as a result.
Pharmaceutical Technology
JUNE 23, 2023
Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.
Bio Pharma Dive
JUNE 14, 2023
The FDA last year turned back an approval request from the drug’s former developer, Levo Therapeutics. That biotech is now owned by Acadia, which will run a new study designed to boost its odds of success.
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.
Bio Pharma Dive
JUNE 27, 2023
A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.
Bio Pharma Dive
JUNE 21, 2023
Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.
Pharmaceutical Technology
JUNE 30, 2023
Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
Bio Pharma Dive
JUNE 26, 2023
By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.
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