Fierce Pharma
JUNE 3, 2023
After a recent data leak reveale | After a recent data leak revealed a dramatic benefit for J&J and Legend’s Carvykti in earlier treatment of multiple myeloma, the pair has peeled back some even more stunning efficacy results that could further pressure Bristol Myers Squibb’s rival CAR-T therapy, Abecma.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 5, 2023
The “dissociative anesthetic” ketamine looks ever more promising as a safe and effective treatment for intractable depression. A new randomized trial from researchers in the United States has shown that injections of ketamine are at least as effective as electroconvulsive therapy (ECT) when treating non-psychotic forms of major depression.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2023
A pill has been shown to halve the risk of death from a certain type of lung cancer when taken daily after surgery to remove the tumor, according to clinical trial results presented on Sunday.
Bio Pharma Dive
JUNE 5, 2023
The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.
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!
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 5, 2023
Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.
Fierce Pharma
JUNE 4, 2023
AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. | AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. Now, the companies are positioning the HER2 antibody-drug conjugate for expansion into other tumor types with data that researchers view as very compelling.
Bio Pharma Dive
JUNE 8, 2023
The biotech’s experimental drug, currently in Phase 1 testing, has drawn investor attention despite a difficult funding environment for drug startups.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 7, 2023
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.
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
Pharmaceutical Technology
JUNE 6, 2023
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.
Pharma Times
JUNE 8, 2023
Laboratory space will accelerate the development of potentially life-saving cell therapies - News - PharmaTimes
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 8, 2023
The artificial sweetener sucralose (marketed as Splenda) is widely used and found in products like diet soda and chewing gum. According to a new study, it’s also capable of damaging the DNA material inside our cells.
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
Pharma Times
JUNE 8, 2023
Emergence of quick test follows recent dramatic increase in sexually transmitted infections - News - PharmaTimes
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 7, 2023
Researchers have recently shown that separate mechanisms drive the hallucinogenic and antidepressant effects of psychedelics like LSD and psilocin, potentially paving the way to use these ‘party drugs’ as treatments that don’t trigger psychedelic trips.
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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
Pharmaceutical Technology
JUNE 4, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on on Innovation in Pharmaceuticals: Transcription facto
Pharma Times
JUNE 6, 2023
The structure of NanoBone triggers bone-forming systems while also aiding rapid bone healing - News - PharmaTimes
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 8, 2023
Indian hospitals have now set their sights on green healthcare infrastructure in an effort to improve patient recovery while making use of natural resources in an efficient and environment-friendly manner. According to Ravideep Singh, associate director, Creative Designer Architects, designing sustainable healthcare infrastructure is gaining traction.
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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.
Pharmaceutical Technology
JUNE 8, 2023
Each week, Pharmaceutical Technology’s editors select a deal that illustrates the themes driving change in our sector. The deal may not always be the largest in value, or the highest profile. But it will tell us where the leading companies are focusing their efforts, and why. This new, thematic deal coverage is driven by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors.
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.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2023
There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act.
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.
Pharmaceutical Technology
JUNE 8, 2023
The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. It induces remyelination of axons to normal levels, increases muscle coordination, agility, mass, grip and strength, and improves electrophysiological measurem
Pharma Times
JUNE 9, 2023
Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes
Bio Pharma Dive
JUNE 6, 2023
The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.
Rethinking Clinical Trials
JUNE 8, 2023
The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 2023 Real World Data Scholars Program. This program supports the development of advanced graduate students, postdoctoral fellows, and early-career faculty who are interested in developing their expertise and experience in working with electronic health record (EHR) data.
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