Bio Pharma Dive
AUGUST 23, 2023
The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.
Pharmaceutical Technology
AUGUST 23, 2023
Revive has begun the development of a next-generation formulation of Bucillamine to treat public health emergencies.
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Bio Pharma Dive
AUGUST 23, 2023
Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 23, 2023
Our immune system is made up of multiple smart defenses built into our bodies – but if those defenses go haywire, it can lead to diseases such as multiple sclerosis (MS). Scientists may have found a new way to control potentially dangerous autoimmune responses.
Bio Pharma Dive
AUGUST 23, 2023
The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years.
Pharmaceutical Technology
AUGUST 23, 2023
CROs need to move with the times as artificial intelligence can help deliver more cost-efficient clinical trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 23, 2023
Celcuity has entered a partnership to use Bayer’s Nubeqa in an upcoming Phase Ib/II prostate cancer trial investigating gedatolisib.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 23, 2023
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. The alert follows the World Health Organisation (WHO)’s communication about a safety threat which has been identified with falsified versions of these products being available in the market.
Rethinking Clinical Trials
AUGUST 23, 2023
In this Friday’s PCT Grand Rounds, Gabriela Schmajuk of the University of California, San Francisco, will present “Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges.” The Grand Rounds session will be held on Friday, August 25, 2023, at 1:00 pm eastern. Schmajuk is a professor of medicine at UCSF and the chief of rheumatology at the San Francisco VA Health Care System.
Pharmaceutical Technology
AUGUST 23, 2023
The EC has granted approval to Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for stage IIB or IIC melanoma patients.
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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
XTalks
AUGUST 23, 2023
This episode features an interview with Dr. William Williams, CEO of BriaCell Therapeutics, a biotech company based in Philadelphia that is dedicated to developing novel immunotherapies to fight cancer and improve patient lives. William V. Williams, MD, FACP President & Chief Executive Officer BriaCell Therapeutics Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceut
Pharmaceutical Technology
AUGUST 23, 2023
Physicians with experience with using AI in their practices were more open to sales representatives using AI to personalise messaging.
CTTI (Clinical Trials Transformation Initiative)
AUGUST 23, 2023
The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.
Pharmaceutical Technology
AUGUST 23, 2023
The US HHS has granted over $1.4bn for Project NextGen to facilitate the development of new vaccines and therapeutics for Covid-19.
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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
ACRP blog
AUGUST 23, 2023
The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other nations, the ICH document outlines regulators’ expectations on how DCTs should be conducted, and with its addition to the list, stakeholders in digital, hybrid, and fully
Pharmaceutical Technology
AUGUST 23, 2023
Obesity and type 2 diabetes (T2D) drugs have provided significant increases in revenue growth for Novo Nordisk and Eli Lilly
BioPharma Reporter
AUGUST 23, 2023
With so many advanced therapies on the horizon, the next few years are poised to be one of significant progress for patients with over 2000 cell and gene therapies in active clinical trials globally.
Pharmaceutical Technology
AUGUST 23, 2023
The programme is part of US BARDA’s ‘Project NextGen’ to develop countermeasures against Covid-19 current and future strains.
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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
AUGUST 23, 2023
The varicella zoster virus that causes shingles and chicken pox is typically present in over 90% of adults globally - News - PharmaTimes
Pharmaceutical Technology
AUGUST 23, 2023
As China looks set to miss 5% growth target, Western firms invested in the pharma market find their growth lacking as well.
BioSpace
AUGUST 23, 2023
Data suggests divarasib could be more potent than already approved KRAS inhibitors from Amgen and Mirati, but the study’s authors caution against cross-trial comparisons.
Pharmaceutical Technology
AUGUST 23, 2023
Japan granted approval for Daiichi Sankyo and AstraZeneca’s Enhertu to treat non-small cell lung cancer (NSCLC) in adults.
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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.
Pharma Times
AUGUST 23, 2023
The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy - News - PharmaTimes
Pharmaceutical Technology
AUGUST 23, 2023
Apellis has advised against using 19-gauge injection kits to administer Syfovre due to reports of retinal vasculitis.
Fierce Pharma
AUGUST 23, 2023
In October of last year, GSK laid out a plan to double its business in China by 2025, with much of that expansion dependent upon the succe | In October of last year, GSK laid out a plan to double its business in China by 2025, with much of that expansion dependent upon the success of shingles vaccine Shingrix. On Wednesday, GSK left little doubt about the benefit of Shingrix as it reported 100% efficacy from a post-licensing trial of the shot.
Pharmaceutical Technology
AUGUST 23, 2023
Bayer’s new Consumer Health businesses taps into Mahana’s FDA-approved digital therapeutic for IBS.
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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.
BioSpace
AUGUST 23, 2023
The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
Fierce Pharma
AUGUST 23, 2023
After floating the idea earlier this month, Mallinckrodt has formally declared its intention to kick off another round of bankruptcy proceedings in the coming days. | After floating the idea earlier this month, Mallinckrodt has formally declared its intention to kick off another round of bankruptcy proceedings in the coming days. But questions remain on just how much the move will affect the company’s looming opioid payouts.
BioSpace
AUGUST 23, 2023
As the new executive VP and chief development officer of BrainStorm, Dagher is tasked with securing FDA approval of NurOwn for the treatment of ALS.
ACRP blog
AUGUST 23, 2023
The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other nations, the ICH document outlines regulators’ expectations on how DCTs should be conducted, and with its addition to the list, stakeholders in digital, hybrid, and fully
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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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