Bio Pharma Dive
AUGUST 18, 2023
BSCA has kicked CVS Caremark, the largest pharmacy benefit manager in the country, to the curb and is electing to carve out various pharmacy functions with companies like Amazon instead.
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharmaceutical Technology
AUGUST 15, 2023
The biologic was able to halt disease progression in rheumatoid arthritis with the same effectiveness as gold-standard treatment Remicade.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 15, 2023
By replacing fluorescent molecules in an existing imaging process with ones that instead scatter light, researchers have revealed a whole new level of dazzling details within our living cells. The innovative tweak will allow scientists to directly observe molecular behavior over a much longer period, opening a window onto pivotal biological processes like cell division.
Bio Pharma Dive
AUGUST 15, 2023
More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.
Rethinking Clinical Trials
AUGUST 17, 2023
When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. To address these questions, the American Journal of Bioethics ( AJOB ) recently published commentaries on 2 target articles in a special issue on pragmatic clinical trials.
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
AUGUST 13, 2023
A tiny fraction of people are naturally resistant to HIV infections, and scientists want to understand why. Now an international team of researchers has discovered a new genetic variant in people of African ancestries that appears to restrict HIV replication after an infection sets in.
Bio Pharma Dive
AUGUST 17, 2023
A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.
Rethinking Clinical Trials
AUGUST 16, 2023
From left: Martin Landray, Khair ElZarrad, and Adrian Hernandez In this Friday’s PCT Grand Rounds, Martin Landray of the University of Oxford, Khair ElZarrad of the US Food and Drug Administration, and Adrian Hernandez of Duke University will present “Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6[R3]).” The Grand Rounds session will be held on Friday, August 18, 2023, at 1:00 pm eastern.
Pharmaceutical Technology
AUGUST 18, 2023
Bruker has entered into a definitive agreement to acquire functional cell biology company PhenomeX for a total equity value of $108m.
Advertisement
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
AUGUST 17, 2023
There’s a small fatty gland that sits behind your sternum and is often said to be ‘useless’ in adulthood.
Bio Pharma Dive
AUGUST 14, 2023
Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
Pharmaceutical Technology
AUGUST 18, 2023
The decision brings the first daily oral migraine prophylactic to Europe, with plans to rollout the treatment as soon as possible.
Advertisement
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 14, 2023
The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […]
Bio Pharma Dive
AUGUST 16, 2023
The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review.
XTalks
AUGUST 18, 2023
After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug. However, Elrexfio will be going up head-to-head against Johnson & Johnson’s BCMA-targeted therapy Tecvayli (teclistamab).
Pharmaceutical Technology
AUGUST 16, 2023
The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 14, 2023
There’s a whole world inside your gut, made up of mostly harmless microbes that reside in the gastrointestinal tract.
Bio Pharma Dive
AUGUST 14, 2023
Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
Drug Patent Watch
AUGUST 17, 2023
Annual Drug Patent Expirations for LUMASON Lumason is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Bracco drug LUMASON appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 16, 2023
Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.
Advertisement
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
XTalks
AUGUST 17, 2023
New Culture, one of several emerging startups using precision fermentation to produce casein proteins, has scaled up its fermentation process to now make manufacturing volumes, specifically for its animal-free mozzarella. The company is confident that it can scale up while maintaining price parity with traditional mozzarella within the next three years.
Bio Pharma Dive
AUGUST 16, 2023
The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.
Drug Patent Watch
AUGUST 16, 2023
Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are nine patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 18, 2023
Astellas Pharma has announced that EMA has accepted the MAA from its subsidiary Iveric Bio for the review of ACP to treat GA.
Advertisement
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.
Fierce Pharma
AUGUST 18, 2023
It was only last spring that Biogen started a | It was only last spring that Biogen started layoffs that eventually shrank the company’s headcount by nearly 900 people last year. Now, a fresh round of job cuts targeting 1,000 positions has kicked off at the struggling drugmaker. At the same time, Biogen is spending $7.3 billion to buy rare disease specialist Reata Pharmaceuticals.
Bio Pharma Dive
AUGUST 15, 2023
San Diego-based Tentarix will receive $66 million in cash and equity from Gilead, which holds an option to acquire up to three of the company’s subsidiaries.
Antidote
AUGUST 16, 2023
Primary sclerosing cholangitis (PSC) is a condition that impacts the bile ducts of the liver, causing them to become inflamed and ultimately scar. It primarily affects young and middle-aged men, and 80% of patients with PBC also have inflammatory bowel disease (IBD).
Pharmaceutical Technology
AUGUST 18, 2023
Depending on Phase III results, survodutide could soon enter the weight loss market, which is expected to reach $37.1bn by 2031.
Advertisement
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.
Expert insights. Personalized for you.
246 
Let's personalize your content