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.
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.
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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 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.
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.
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.
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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 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.
Rethinking Clinical Trials
JUNE 7, 2023
Dr. Shirley Wang In this Friday’s PCT Grand Rounds, Shirley Wang of Harvard Medical School will present “Emulating Randomized Clinical Trials With Non-randomized Real-World Evidence Studies: Results From the RCT DUPLICATE Initiative.” The Grand Rounds session will be held on Friday, June 9, 2023, at 1:00 pm eastern. The DUPLICATE initiative is building an empirical evidence base for using longitudinal insurance claims prospectively to achieve large-scale replication of randomiz
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.
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
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
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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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
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
Fierce Pharma
JUNE 7, 2023
Merck has taken the lead, filing a lawsuit seeking to overturn drug pricing measures in the Inflation Reduction Act (IRA). | Merck has filed a lawsuit seeking to overturn drug-pricing measures in the Inflation Reduction Act (IRA). Now, emboldened by the New Jersey drugmaker, other biopharma CEOs are making their concerns known. At the BIO International Convention, Biogen CEO Chris Viehbacher registered severe criticism of the IRA and said his company was considering filing its own lawsuit.
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.
Pharma Times
JUNE 9, 2023
Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes
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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.
Pharmaceutical Technology
JUNE 8, 2023
The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS). While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the dr
JAMA Internal Medicine
JUNE 4, 2023
This quality improvement study examines the association between the discontinuation of universal admission testing for SARS-CoV-2 infections and hospital-onset SARS-CoV-2 infections in England and Scotland.
Bio Pharma Dive
JUNE 5, 2023
Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.
Drug Patent Watch
JUNE 8, 2023
17th Edition Project Portfolio and Resource Management Excellence for Pharma July 11-13, 2023 | Sheraton Philadelphia University City Hotel | Philadelphia, PA Mastering Resource and Project Prioritization, Operational Excellence, and People Development… The post 17th Edition Project Portfolio and Resource Management Excellence for Pharma appeared first on DrugPatentWatch - Make Better Decisions.
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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.
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