Bio Pharma Dive
NOVEMBER 8, 2023
A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.
BioSpace
NOVEMBER 5, 2023
Navigating the Challenges of Clinical Trial Design - read this article along with other careers information, tips and advice on BioSpace
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Fierce Pharma
NOVEMBER 8, 2023
In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. | In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. Now in his fifth month as CEO at struggling conglomerate Bayer, Anderson is focused on an even larger renovation, saying the company is on its way to a “radical realignme
BioSpace
NOVEMBER 5, 2023
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
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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
NOVEMBER 10, 2023
The trial is testing whether Mavenclad could benefit upper limb movement in MS patients - News - PharmaTimes
Bio Pharma Dive
NOVEMBER 8, 2023
CEO Chris Viehbacher said the company has “the elements to think about a return to topline growth.” Yet, that goal hinges on the successful commercialization of multiple new products.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
ACRP blog
NOVEMBER 8, 2023
As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures. “With retail pharmacies entering the clinical trial space, investigative sites are left with little information around how this move will affect them or their patien
Pharmaceutical Technology
NOVEMBER 10, 2023
The US FDA has granted approval for Takeda’s Adzynma for congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.
Bio Pharma Dive
NOVEMBER 8, 2023
The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 6, 2023
Ever feel like everything hurts after not getting enough sleep? A new study reveals a neurotransmitter involved in the pain that sleep deprivation causes, indicating a potential new target for treatment. In sleep-deprived mouse models, the neurotransmitter N-arachidonoyl dopamine (NADA), an endocannabinoid, was reduced in one brain region linked to sensory processing and arousal.
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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
Worldwide Clinical Trials
NOVEMBER 10, 2023
Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar
Pharmaceutical Technology
NOVEMBER 9, 2023
GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.
Bio Pharma Dive
NOVEMBER 7, 2023
Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 8, 2023
When people think of foods related to type 2 diabetes, they often think of sugar (even though the evidence for that is still not clear). Now, a new study from the US points the finger at salt.
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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.
Worldwide Clinical Trials
NOVEMBER 10, 2023
As someone who joined the military right after high school, I can say that it was one of the best decisions I ever made. My nearly perfect score on the Armed Services Vocational Aptitude Battery Test (ASVAB) qualified me for three positions, and I ended up taking the one that required a top-secret/SCI security clearance – as a Record Telecommunications Center Operator.
Pharmaceutical Technology
NOVEMBER 10, 2023
AstraZeneca has posted a profit after tax of $1.37bn for Q3 2023 versus $1.64bn in the same quarter of the previous year, a decline of 16%.
Bio Pharma Dive
NOVEMBER 7, 2023
The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 9, 2023
An ingredient once commonly used in citrus-flavored sodas to keep the tangy taste mixed thoroughly through the beverage could finally be banned for good across the US.
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.
Fierce Pharma
NOVEMBER 7, 2023
Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.
Pharmaceutical Technology
NOVEMBER 6, 2023
GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.
Bio Pharma Dive
NOVEMBER 9, 2023
Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.
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.
Fierce Pharma
NOVEMBER 8, 2023
In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In addition, Lilly said it will charge 20% less than Novo for its obesity med in an attempt to provide increased access.
Pharmaceutical Technology
NOVEMBER 6, 2023
Krazati received conditional marketing authorisation as a second-line treatment of KRAS-G12C mutated locally advanced or metastatic NSCLC.
Bio Pharma Dive
NOVEMBER 7, 2023
The biotech company creator hopes its new office will help its portfolio companies grow and strike partnerships in the region.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 9, 2023
In an effort to ensure a stable and cost-effective supply chain for active pharmaceutical ingredients (APIs) in the country, the Department of Pharmaceuticals (DoP) may look at tapping the potential of international collaborations for sourcing of raw materials and manufacturing of ingredients in the country.
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
Fierce Pharma
NOVEMBER 6, 2023
History may repeat for Vertex Pharmaceuticals in the U.K., where a new decision by the country’s cost-effectiveness gatekeeper threatens to spark another dispute over the cost of lifesaving cystic | Last week, the U.K.'s National Institute for Health and Care Excellence unveiled draft guidance that acknowledged the effectiveness of Vertex’s cystic fibrosis drugs Trikafta, Symkevi and Orkambi.
Pharmaceutical Technology
NOVEMBER 6, 2023
At AAO 2023, results were presented from the Phase III GALE trial, evaluating Apellis Pharmaceuticals’s Syfovre to treat geographic atrophy (GA).
Bio Pharma Dive
NOVEMBER 10, 2023
Cargo Therapeutics is the seventh oncology biotech to successfully price an IPO this year.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
The Tamil Nadu Drug Control Administration (TN DCA) has initiated action against the use of analgesic and anti-inflammatory drugs, diclofenac and aceclofenac, in veterinary treatments on account of sharp decline in vulture population in the forest areas of the state.
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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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