Pharmaceutical Technology
JUNE 20, 2023
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.
Bio Pharma Dive
JUNE 22, 2023
The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2023
A type of bacteria commonly found in human oral and gut flora could play a major role in the development of endometriosis, scientists have discovered – potentially giving us crucial insight into the development of the painful condition, and opening up new ways to treat it.
Pharma Mirror
JUNE 23, 2023
In the fast-paced, highly competitive pharmaceutical industry, sales reps must adapt to new ways of engaging with customers and healthcare professionals (HCPs). Two such approaches are through the use of omnichannel and sales enablement technologies, which can revolutionize the way pharmaceutical companies develop their sales force and interact with their stakeholders.
Pharmaceutical Technology
JUNE 23, 2023
Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.
Bio Pharma Dive
JUNE 21, 2023
While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
JUNE 23, 2023
LAUSANNE, Switzerland – Viseven, a leading global MarTech services provider for the Pharma and Life Sciences industries, is thrilled to announce its partnership with SpotMe, an enterprise event platform tailored to high-touch industries. This collaboration marks a significant milestone in digital communication within the healthcare industry. Driving Success in Pharma Communication The partnership between Viseven and SpotMe creates a unique point of view on the HCP engagement and B2B event organi
Pharmaceutical Technology
JUNE 21, 2023
AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.
Bio Pharma Dive
JUNE 22, 2023
The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
A large study covering 37 years from start to finish has revealed something about those who tend to stay up late: These night owls are more likely to die at a younger age, but due to smoking and drinking-related causes rather than how late they go to bed.
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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
Rethinking Clinical Trials
JUNE 22, 2023
Taunton Paine, Director of the NIH Scientific Data Sharing Policy Division At the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in May, we interviewed Taunton Paine, director of the NIH Scientific Data Sharing Policy Division, about the NIH’s new Data Management & Sharing Policy , which took effect in 2023. Under the new policy, all NIH-funded research requires a submission plan that describes how, where, and when data will be shared.
Pharmaceutical Technology
JUNE 20, 2023
Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.
Bio Pharma Dive
JUNE 21, 2023
Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 22, 2023
Scientists have demonstrated how nasal drops containing a particular molecule can help mice recover from the damaging biological consequences of a stroke – and the hope is that the treatment could eventually be transferred to humans. [link] Crucially, the treatment isn’t applied straight away but is initiated seven days after the stroke.
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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.
Rethinking Clinical Trials
JUNE 21, 2023
In this Friday’s PCT Grand Rounds, Miguel Vazquez of the University of Texas Southwestern Medical Center and George “Holt” Oliver of the Parkland Center for Clinical Innovation will present “Improving Delivery of Care for Chronic Kidney Disease, Diabetes, and Hypertension,” including results from the ICD-Pieces Demonstration Project.
Pharmaceutical Technology
JUNE 19, 2023
UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.
Bio Pharma Dive
JUNE 20, 2023
The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2023
Scientists have discovered cannabidiol, a compound in cannabis known as CBD, in a common Brazilian plant, opening potential new avenues to produce the increasingly popular substance, a lead researcher said Thursday.
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
JUNE 22, 2023
Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.
Pharmaceutical Technology
JUNE 19, 2023
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. The pharma company will in-license a small number of gene therapy products and offer research grants to advance them through pre-clinical development. Laurus Labs will be responsible for launching these products in India and emerging markets.
Bio Pharma Dive
JUNE 23, 2023
In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 22, 2023
The Central Drugs Standard Control Organisation (CDSCO) has said that a joint investigation team of its East Zone office and the State Licensing Authority (SLA) of Sikkim have declared the samples of Glenmark Pharmaceuticals’ blood pressure-lowering drug Telma 40 failed in the quality tests in February, 2023, as spurious.
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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
Fierce Pharma
JUNE 20, 2023
Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.
Pharmaceutical Technology
JUNE 22, 2023
Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children
Bio Pharma Dive
JUNE 23, 2023
Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
The Central Drugs Standard Control Organisation (CDSCO) has started carrying daily updates of the number of batches of cough syrup samples submitted with each of the laboratories prior to exports in its website, in order to enable time bound testing and release of reports.
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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.
Fierce Pharma
JUNE 20, 2023
Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said.
Pharmaceutical Technology
JUNE 21, 2023
The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. The delivery candidate, called TPU-006, delivers dexmedetomidine for up to four days. Dexmedetomidine is a common non-opioid analgesic that activates alpha-2 receptors, which inhibits the release of noradrenaline and subsequent propagation of pain signals.
Bio Pharma Dive
JUNE 20, 2023
Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2023
The Drugs Technical Advisory Board (DTAB), which advises the Central and State governments on the technical matters related to the drugs regulation and administration, has recommended a stakeholder’s consultation to develop a strategy to address the issue of usage of banned antibiotics in food producing animals, in the wake of the rising trend of rejections […]
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