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 15, 2023
Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. Following underwhelming topline results from the Phase II trial (NCT04135495) announced in late 2022, Eloxx recalculated the results using the change in ppFEV1 (a secondary outcome) from day 1 instead of from baseline.
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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.
Pharma Mirror
JUNE 16, 2023
The Hague — Plans to develop FIP-UNESCO UNITWIN centres for excellence for pharmacy education across the world have been bolstered by a renewed agreement between the International Pharmaceutical Federation (FIP) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) concerning the UNITWIN Network on Global Pharmacy Education Development, the federation announced today.
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).
Pharmaceutical Technology
JUNE 13, 2023
Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
JUNE 16, 2023
OTTAWA – As a new fiscal year unfolds, the Canadian Dental Hygienists Association (CDHA) celebrates its long-standing partnerships with dental industry. These meaningful collaborations have been instrumental in moving the dental hygiene profession forward and in building awareness across Canada of the importance of oral health and its impact on our overall health.
Bio Pharma Dive
JUNE 12, 2023
Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 11, 2023
People who took a cheap diabetes drug after testing positive for COVID-19 had a 40 percent lower risk of getting long COVID, a US-based study said Friday.
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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
Pharma Mirror
JUNE 16, 2023
Maintaining optimal tablet tooling is paramount for achieving effective production outcomes. Inadequate handling and aftercare methods are responsible for 85% of punch and die problems. To address this critical issue, I Holland, leader in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has developed Safestore and tool tray racking, an innovative system designed to securely store tooling.
Bio Pharma Dive
JUNE 12, 2023
DeSouza is departing unrepentant about his decision to close the Grail deal, telling colleagues his belief in the merger “remains unshakeable.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 13, 2023
A group of researchers at the Kolkata-based S N Bose National Centre for Basic Sciences has developed non-invasive method of recognising breath patterns that can help rapid, one-step diagnosis and classification of various gastric disorders like dyspepsia, gastritis, and gastroesophageal reflux disease (GERD).
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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.
Pharma Mirror
JUNE 15, 2023
In recent years, the field of clinical trials has witnessed a significant transformation due to advancements in technology. The integration of technology into clinical trials has revolutionized the way researchers conduct studies, collect data, and analyze results. This article explores the current trends in clinical trial technology and their impact on the research landscape.
Bio Pharma Dive
JUNE 13, 2023
In a sign of the impact the downturn has had on young biotechs, Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is “substantial doubt” it can survive.
Pharmaceutical Technology
JUNE 12, 2023
Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceutical products, orphan drugs and other life-saving medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 15, 2023
The Tamil Nadu Pharma Traders Association (TN PTA), a registered body of 30,000 pharmaceutical wholesalers and retailers working in the 30 districts of the state, has approached the director-in-charge of the drugs control administration (DCA) with a request to the DTAB and the DCC under the union health ministry to allow three months time for […]
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.
Pharma Mirror
JUNE 15, 2023
Sarin Akter, a dynamic healthcare sales agent from Moulavibazar, Bangladesh, has been recently honored with iDE’s esteemed “40 Under 40” award. This recognition is a testament to her transformative influence in facilitating access to vital health products in rural Bangladesh. Navigating the complex terrain of rural healthcare sales, Sarin overcame challenges posed by entrenched misconceptions among locals, such as beliefs that modern medicine could lead to infertility in women.
Bio Pharma Dive
JUNE 16, 2023
The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.
Pharmaceutical Technology
JUNE 16, 2023
Flamingo Therapeutics has received a research grant of €1.7m from Flanders Innovation & Entrepreneurship (VLAIO) to further advance its oncology portfolio targeting RNA. The grant will help Flamingo to support its translational research in a Phase II study of its lead clinical programme, danvatirsen, to treat head and neck squamous cell carcinoma.
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.
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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
BioSpace
JUNE 12, 2023
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
Bio Pharma Dive
JUNE 12, 2023
The Swiss pharma is betting that two experimental drugs the biotech has developed for IgA nephropathy will succeed in late-stage testing, one of which will deliver results later this year.
Pharmaceutical Technology
JUNE 16, 2023
Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The approval has been granted for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) caused by follicular lymphoma, after two or more systemic therapy lines.
Fierce Pharma
JUNE 12, 2023
Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.
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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.
Pharma Times
JUNE 13, 2023
525-patient trial intends to assess ‘complement activation’ during HD in patients with end stage renal failure - News - PharmaTimes
Bio Pharma Dive
JUNE 15, 2023
The biosimilar developer’s plans to set steep discounts on its copycat version of AbbVie’s Humira set off a legal back-and-forth between the companies.
Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid. It comprises a heterogeneous population of growth factors, exosomes, cytokines, microRNAs and chemokines. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.
Fierce Pharma
JUNE 16, 2023
In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.
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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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