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.
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.
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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
The Polish drug discovery and service provider Selvita has announced a new collaboration with the University of Oxford to advance the development of Parkinson’s disease therapies. Parkinson’s is caused by a build-up of alpha-synuclein, a small protein, forming aggregates inside vulnerable neurons. Cells are then unable to efficiently clear these aggregates, potentially killing neurons and allowing the disease to progress.
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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 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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
Bio Pharma Dive
JUNE 5, 2023
Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.
Pharmaceutical Technology
JUNE 5, 2023
ITM (Isotope Technologies Munich) has announced a €255 million ($273.16 million) equity investment funding raise. According to ITM’s CEO Steffen Schuster, the raise is one of the largest private biotechnology financing rounds to date in the company’s home market, per the 5 June announcement. The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities.
Bio Pharma Dive
JUNE 5, 2023
Biocorp’s “smart pen” technology could improve diabetes management and potentially be used in other areas Novo works in like obesity, one analyst said.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Pharmaceutical Technology
JUNE 5, 2023
Summit Therapeutics has announced data for its novel investigational bispecific antibody, ivonescimab, known as SMT112 or AK112 in a non-small cell lung cancer study. In results presented at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting , Summit reported an overall response rate (ORR) of 67% in NSCLC patients with squamous histology treated with its lead drug ivonescimab plus chemotherapy.
Bio Pharma Dive
JUNE 5, 2023
The biotech’s experimental NASH medicine, combined with drugs like Ozempic, helped to improve markers of the fatty liver disease.
Deltaclinical
JUNE 5, 2023
Clinical trials are an indispensable part of medical research, testing new treatments and pharmaceuticals to improve health care. Traditionally, these studies were conducted in medical facilities, but today clinical studies with home visits are becoming increasingly popular. In this blog post, we will explore the benefits of clinical trials with home visits from the patient’s perspective. 1.
Bio Pharma Dive
JUNE 5, 2023
As the lobbying group holds its annual meeting in Boston, BIO’s interim leader is trying to focus attention back on the industry’s most pressing priorities, like pushing back on the IRA.
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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.
Pharmaceutical Technology
JUNE 5, 2023
Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report.
XTalks
JUNE 5, 2023
Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older. Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains.
Pharmaceutical Technology
JUNE 5, 2023
Results unveiled at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting indicate that some patients with locally advanced rectal cancer can be treated with chemotherapy alone and may not need radiation therapy before surgery. After five years, the treatment efficacy demonstrated in patients who received chemotherapy (and radiation as needed) versus patients who just received radiation therapy was found to be non-inferior.
Antidote
JUNE 5, 2023
Hunter’s disease, also known as Hunter syndrome or MPS II, is an inherited disease that impacts the X chromosome. Though it is a rare condition, it is one that can significantly impact children and their families. Currently, there is no known cure for Hunter syndrome , but there are ways that care providers can help diagnosed individuals manage their symptoms.
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 5, 2023
China’s National Medical Products Administration (NMPA) has accepted Akeso’s new drug application (NDA) for ebronucimab (AK102) for two indications. Ebronucimab is intended to treat heterozygous familial hypercholesterolemia (HeFH), primary hypercholesterolemia and mixed hyperlipidemia. It is a fully human anti-PCSK9 monoclonal antibody co-developed by the company and AD Pharmaceuticals.
XTalks
JUNE 5, 2023
Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. Wegovy, in conjunction with diet and exercise, is authorized to assist adults and children aged 12 years and older struggling with obesity, or some adults grappling with excess weight alongside weight-related medical conditions, in their eff
Pharmaceutical Technology
JUNE 5, 2023
German biotechnology company Evotec has secured a $1.7m grant from a philanthropic funder, Open Philanthropy, to research RNA-targeting henipavirus therapeutics. The company will use the funding for the discovery and development of small molecule antivirals that target viral RNA in henipaviruses, a genus of zoonotic viruses that can cause fatal encephalitis in humans.
BioPharma Reporter
JUNE 5, 2023
BenevolentAI, a clinical-stage AI development company, has announced the successful delivery of its pre-clinical candidate for the potential treatment of amyotrophic lateral sclerosis (ALS), BEN-34712.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Technology
JUNE 5, 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Bristol-Myers Squibb’s mavacamten (Camzyos) as an add-on to standard care to control symptoms of obstructive hypertrophic cardiomyopathy (HCM). The symptoms of obstructive HCM include fatigue, palpitations and shortness of breath.
BioSpace
JUNE 5, 2023
In a lawsuit filed Tuesday in federal district court, Merck claimed that the price negotiation program laid out in the Inflation Reduction Act violates the U.S. Constitution.
Pharmaceutical Technology
JUNE 5, 2023
PharmaEssentia has chosen Pint-Pharma as commercial partner for BESREMi (ropeginterferon alfa-2b-NJFT) in Latin America. The companies have entered into an exclusive licence agreement to register and promote BESREMi to treat polycythemia vera (PV), a rare type of blood cancer, in Ecuador, Chile, Mexico, Argentina, Brazil, Colombia and Peru. PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product.
Pharma Times
JUNE 5, 2023
New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes
Advertiser: FourKites
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.
Pharmaceutical Technology
JUNE 5, 2023
AB-1003is under clinical development by Asklepios BioPharmaceutical and currently in Phase II for Limb-Girdle Muscular Dystrophy.
Fierce Pharma
JUNE 5, 2023
After a postmarketing study of AstraZeneca's bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.< | The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug.
Pharmaceutical Technology
JUNE 5, 2023
Camidanlumab tesirineis under clinical development by ADC Therapeutics and currently in Phase II for Myelodysplastic Syndrome.
BioSpace
JUNE 5, 2023
A Kenilworth, NJ, R&D campus that formerly served as Merck’s global headquarters is now set to reopen and become the Northeast Science and Technology (NEST) Center.
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
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