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.
Pharmaceutical Technology
JUNE 14, 2023
The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. Inobrodib is an oral first-in-class cancer drug, indicated for patients who have previously received four or more lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent and a proteasome inhibitor.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 14, 2023
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.
Bio Pharma Dive
JUNE 14, 2023
The alliance is Astellas’ second recent partnership involving protein degraders, an emerging area of drug research the company has made a focus in recent years.
Pharmaceutical Technology
JUNE 14, 2023
The European Patent Office (EPO) has issued an intention to grant a patent for Vistagen’s new PH80 nasal spray to treat migraine. The patent’s claims also include treatment given at the onset of migraine symptoms as well as the treatment of migraines associated with traumatic brain injury. The patent will remain active until at least 2040. PH80 is a first-in-class, rapid-onset nasal spray designed to be used in a similar way to a rescue asthma inhaler.
Bio Pharma Dive
JUNE 14, 2023
Researchers at study sponsor Seattle Children's have halted testing as they investigate the death and its potential link to the CAR-T treatment.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
JUNE 14, 2023
In this Friday’s PCT Grand Rounds, Julie Fritz and Guilherme Del Fiol of the University of Utah will present “BeatPain Utah Pragmatic Clinical Trial: Partnering With Community Health Centers Within a Socio-Technical Framework.” The Grand Rounds session will be held on Friday, June 16, 2023, at 1:00 pm eastern. BeatPain Utah , an NIH Collaboratory Demonstration Project, is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back
Pharmaceutical Technology
JUNE 14, 2023
The Council of the EU has adopted recommendations proposed by the European Commission (EC) to combat antimicrobial resistance (AMR), setting targets for reduced antimicrobial use and increased surveillance. The recommendations to combat AMR propose that there should be a 20% reduction in the total human consumption of antibiotics by 2030 alongside an even larger pushback against their use in animals, per the 13 June announcement.
Bio Pharma Dive
JUNE 14, 2023
The time period for the Federal Trade Commission to request more information on the $43 billion acquisition now extends through mid-July.
Pharmaceutical Technology
JUNE 14, 2023
Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonid
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 14, 2023
The Union health ministry will soon amend the Recruitment Rules for the post of Assistant Drugs Inspector (Medical Devices) in Central Drugs Standard Control Organization (CDSCO). The ministry has now invited suggestions on the proposed amendment. The Ministry is also examining the proposal for amendment of Recruitment Rules towards making the provision.
Pharmaceutical Technology
JUNE 14, 2023
Senju Pharmaceutical and Novaliq have closed a licence agreement for NOV03 (perfluorohexyloctane ophthalmic solution) to treat dry eye disease in Japan. The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country. NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface.
Rethinking Clinical Trials
JUNE 14, 2023
Updated study snapshots and ethics and regulatory documentation are now available for the IMPACt-LBP and INSPIRE trials, both NIH Pragmatic Trials Collaboratory Demonstration Projects. IMPACt-LBP transitioned from the planning phase to the implementation phase in August. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.
Pharmaceutical Technology
JUNE 14, 2023
China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in adult patients. Soliris is a first-in-class C5 complement inhibitor indicated for patients who are anti-acetylcholine receptor (AChR) antibody-positive. It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system.
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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
Fierce Pharma
JUNE 14, 2023
Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making. The platform is one step in the company's digital transformation and goal to become the "first pharma powered by AI at scale.
Pharmaceutical Technology
JUNE 14, 2023
Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Bylvay is a once-a-day, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure.
Fierce Pharma
JUNE 14, 2023
An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout o | An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout of Horizon Therapeutics has raised concerns that the United States’ antitrust watchdog is tightening the screws on major M&A moves in the biopharma industry. A month later, according to an SEC filing, Pfizer has withdrawn its notification for its proposed $43 billion acquisition of cancer drug specialist Seagen and will submit another later in the day.
Pharma Times
JUNE 14, 2023
Find out more about the PharmaTimes Communications Awards 2023 – key dates, categories and which charity we have partnered with this year!
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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.
Outsourcing Pharma
JUNE 14, 2023
In a bid to address the high demand for clinical research talent, Advanced Clinical is hosting an innovation theater at DIA Global in Bostonâs Convention and Exhibition Center.
XTalks
JUNE 14, 2023
This episode features an interview with Dr. Courtney Silverthorn who is an Associate Vice President at the Foundation for the National Institutes of Health (FNIH) and the Director of the Accelerating Medicines Partnership (AMP) program including the Bespoke Gene Therapy Consortium. The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio.
Pharmaceutical Commerce
JUNE 14, 2023
In this latest Harvard Business School Healthcare Alumni Association Q&A, Susan Wilner Golden, DSC, lecturer at the Stanford Graduate School of Business, reveals an untapped $22 trillion global opportunity for all companies and others supporting healthy aging and longer life spans.
XTalks
JUNE 14, 2023
The online marketplace PartnerSlate has made waves in the food and beverage contract manufacturing industry, recently securing a $4 million investment to further its mission of connecting food brands and contract manufacturers. The funding will be used to accelerate the growth of its online marketplace, which is currently digitizing the $200 billion food and beverage contract manufacturing industry.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Outsourcing Pharma
JUNE 14, 2023
Mural Health is on a mission to make it as easy as possible for people to take part in clinical trials, the company will be heading to DIA Global in Boston where they hope to glean a meaningful understanding of the current landscape and hot topics.
XTalks
JUNE 14, 2023
Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Vevye is the first and sole cyclosporine solution specifically prescribed for addressing the signs and symptoms of dry eye disease with efficacy validated after four weeks of treatment.
Outsourcing Pharma
JUNE 14, 2023
Phastar is a specialist biometrics contract research organization offering statistical consulting, clinical trial reporting, data management and data science services and will be providing a presentation and running a workshop to give delegates working in any study function a deeper understanding of the interpretation of common statistical terminolgy.
XTalks
JUNE 14, 2023
Huma Therapeutics, a leading global digital health company, announced this week that it has received multi-condition US Food and Drug Administration (FDA) 510(k) Class II regulatory clearance for its disease management Software as a Medical Device (SaMD) platform. Huma’s SaMD platform powers digital health pathways where data is collected from patients for self-management or for assessment remotely by healthcare professionals.
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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.
Outsourcing Pharma
JUNE 14, 2023
CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they want to help clients 'extract every drop of potential from the RBQM-driven interrogation of their own datasets'. It says it recognizes the importance of educating the industry on the value of this approach.
BioSpace
JUNE 14, 2023
Two children with relapsed T cell acute lymphoblastic leukemia were cleared of cancer while a third died from fungal infection, according to research published Wednesday in The New England Journal of Medicine.
Outsourcing Pharma
JUNE 14, 2023
A statistics manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement.
pharmaphorum
JUNE 14, 2023
At ASCO 2023 last week in Chicago, Editor in Chief Jonah Comstock caught up with Dr Corina Dutcus, SVP clinical development at Eisai US, to talk about the CLEAR trial, one of Eisai’s major abstracts being presented at the show.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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