Bio Pharma Dive
SEPTEMBER 25, 2024
The financing will support a technology designed to make delivery of lentiviral gene therapies, which are typically administered through a complex process, more convenient.
Rethinking Clinical Trials
SEPTEMBER 24, 2024
In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.
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Bio Pharma Dive
SEPTEMBER 23, 2024
The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 25, 2024
(Science Photo Library/Getty Images) Has your doctor asked you to stick out your tongue and say “aaah”? While the GP assesses your throat, they’re also checking out your tongue, which can reveal a lot about your health. The doctor will look for any changes in the tongue’s surface or how it moves.
Fierce Pharma
SEPTEMBER 25, 2024
Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
SEPTEMBER 25, 2024
In this Friday’s PCT Grand Rounds, Tom Lietman of the University of California, San Francisco, will present “Azithromycin for Childhood Mortality: Randomizing Entire Countries.” The Grand Rounds session will be held on Friday, September 27, 2024, at 1:00 pm eastern. Lietman is the Ruth Lee and Phillips Thygeson Distinguished Professor in the Department of Ophthalmology and the Department of Epidemiology and Biostatistics at the University of California, San Francisco, and the d
Pharmaceutical Technology
SEPTEMBER 19, 2024
An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 22, 2024
(Richard Jones/Science Photo Library/Getty Images) Scientists have discovered hundreds of genes that could potentially promote cancer, new research shows. Cancer is typically triggered by some kind of change to our genetic coding that interferes with a cell’s ability to manage its growth.
Fierce Pharma
SEPTEMBER 24, 2024
With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.
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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
pharmaphorum
SEPTEMBER 24, 2024
After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.
Pharmaceutical Technology
SEPTEMBER 24, 2024
The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 22, 2024
The Association of Biotechnology Led Enterprises (ABLE) plays an intrinsic role as India’s bioeconomy propels innovation to leap towards the next phase of bio-manufacturing potential.
Fierce Pharma
SEPTEMBER 24, 2024
After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.
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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.
Bio Pharma Dive
SEPTEMBER 23, 2024
With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.
pharmaphorum
SEPTEMBER 25, 2024
Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.
Pharmaceutical Technology
SEPTEMBER 24, 2024
The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 23, 2024
(Tanja Ivanova/Getty Images) The world is in the midst of an antibiotic resistance crisis that contributes to the death of nearly 5 million people a year. But bacteria aren’t the only mutating pathogens we need to worry about.
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.
Outsourcing Pharma
SEPTEMBER 24, 2024
The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
Bio Pharma Dive
SEPTEMBER 19, 2024
Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.
pharmaphorum
SEPTEMBER 25, 2024
Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 24, 2024
(Wang et al., Small, 2024) Swarms of spherical nanobots barely larger than a virus could one day save hundreds of thousands of lives globally each year by staunching deadly bleeds in the brain.
Fierce Pharma
SEPTEMBER 20, 2024
The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.
Bio Pharma Dive
SEPTEMBER 20, 2024
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the company’s operations in Europe.
pharmaphorum
SEPTEMBER 22, 2024
FTC lawsuit accuses top three PBMs of using a perverse drug rebate system to artificially inflate the price of insulin products and their profits
Pharmaceutical Technology
SEPTEMBER 20, 2024
The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 23, 2024
The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for functions and responsibilities of its zonal, sub-zonal and port offices after almost 13 years, updating the adding procedures including for Risk Based Inspection (RBI) of drug manufacturing sites.
Drug Patent Watch
SEPTEMBER 23, 2024
The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.
Bio Pharma Dive
SEPTEMBER 26, 2024
Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.
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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.
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