pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

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Trials Clinical Trials Clinical Trials FDA Approval 111

Bio Pharma Dive

SEPTEMBER 17, 2022

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million.

Gene Therapy 359

Gene Therapy FDA Approval Gene Production 359

Pharmaceutical Technology

SEPTEMBER 22, 2022

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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Genomics Genome Clinical Trials Clinical Trials 342

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 20, 2022

BA.4.6, a subvariant of the Omicron COVID variant which has been quickly gaining traction in the US, is now confirmed to be spreading in the UK. The latest briefing document on COVID variants from the UK Health Security Agency (UKHSA) noted that during the week beginning August 14, BA.4.6 accounted for 3.3 percent of samples […].

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Clinical Trials Clinical Trials Clinical Research Trials 231

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Rethinking Clinical Trials

SEPTEMBER 20, 2022

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.

Trials 190

Trials Clinical Trials Clinical Trials Development 190

Bio Pharma Dive

SEPTEMBER 23, 2022

Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no regulated options after antibiotics fail.

Regulation 344

Regulation 344

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 21, 2022

The pursuit of a cure for Alzheimer’s disease is becoming an increasingly competitive and contentious quest with recent years witnessing several important controversies. In July 2022, Science magazine reported that a key 2006 research paper, published in the prestigious journal Nature, which identified a subtype of brain protein called beta-amyloid as the cause of Alzheimer’s, […].

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Protein Research Clinical Trials Clinical Trials 214

Pharma Times

SEPTEMBER 21, 2022

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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Genetics Genetic Engineering Engineer Trials 152

Bio Pharma Dive

SEPTEMBER 19, 2022

The FDA's clearances of Zynteglo and Skysona are a boost to Bluebird, and could help lift the research field after a series of setbacks. But selling the high-priced therapies will be a challenge.

Gene Therapy 329

Gene Therapy Gene Research 329

Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.

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In-Vitro Antibody Vaccine Vaccination 279

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 21, 2022

The department-related Parliamentary Committee for ministry of health and family welfare, which has looked into the medical devices regulations and recommended the way forward, has sought the Central government to bring the Department of Pharmaceuticals (DoP) under the Ministry, for better coordination. It has also pitched an idea of setting up a department of medical […].

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Regulation Clinical Trials Clinical Trials Clinical Research 164

NPR Health - Shots

SEPTEMBER 22, 2022

Volunteers for the trial put an arm over a box with hundreds of mosquitoes carrying a genetically modified malaria parasite. Here's why they did it that way — and why the trial holds promise.

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Trials Genetics Vaccine Vaccination 145

Bio Pharma Dive

SEPTEMBER 23, 2022

The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing.

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RNA Medicine Drugs 321

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. Through certain Qualified Treatment Centers in the country, Skysona is anticipated to be made available commercially by the end of this year.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

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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

Clinical Trials

Pharma Times

SEPTEMBER 23, 2022

Link up will involve reporting on role of rapid diagnostics in taking on antimicrobial resistance

In-Vitro 139

In-Vitro 139

NPR Health - Shots

SEPTEMBER 20, 2022

Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.

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145

Bio Pharma Dive

SEPTEMBER 20, 2022

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

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Research 299

Pharmaceutical Technology

SEPTEMBER 23, 2022

Rivus Pharmaceuticals has raised $132m in a Series B funding round to clinically advance its lead candidate, HU6, for the treatment of obesity and cardio-metabolic disorders. RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech. Existing investors of the company, including Longitude Capital, Medicxi and RxCapital, also took part in the round.

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Clinical Development Development Life Science Trials 242

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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.

Clinical Trials

STAT News

SEPTEMBER 22, 2022

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations. Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places.

Genome Project 138

Genome Project Genome Genomics Scientist 138

NPR Health - Shots

SEPTEMBER 20, 2022

Research finds five to 10 minutes daily of a type of strength training for muscles used in breathing can help anyone reduce or prevent high blood pressure. The training can also help elite athletes.

Medicine 141

Medicine Research 141

Bio Pharma Dive

SEPTEMBER 20, 2022

When the company debuted in March, it announced plans to hire 200 employees over two years. Now, it’s laid off nearly half its staff in a year when the biotech sector has experienced a sharp market downturn.

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Marketing 290

Pharmaceutical Technology

SEPTEMBER 23, 2022

Merck (MSD outside of North America) has reported that it received a ruling in favour of the company from the US District Court for the Northern District of West Virginia in a patent infringement suit against Viatris linked to sitagliptin. Sitagliptin is an active ingredient in the Januvia, Janumet and Janumet XR therapies. The suit involved two Merck patents.

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Marketing Sales Vaccine Vaccination 173

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.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 23, 2022

Researchers have found an effective method of getting people to cut down on their drinking: Highlight the increased risk of cancer that comes with it, and pair that with counting each and every drink. Skip advert This particular combination of ‘why to reduce’ and ‘how to reduce’ messaging can be useful for promoting good health […].

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Scientist Research Clinical Trials Clinical Trials 130

NPR Health - Shots

SEPTEMBER 19, 2022

For bands on tour, one positive COVID test can spell disaster. With audiences increasingly unmasked and institutional support drying up, safety is left mostly to the artists themselves.

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Bio Pharma Dive

SEPTEMBER 19, 2022

Elevate pharma product development and marketing through collaboration with physician experts

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Pharma Production Production Marketing Development 290

Pharmaceutical Technology

SEPTEMBER 23, 2022

Dry eye syndrome (DES) is an indication whose mainstay treatment has been dominated by Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%) ever since its launch in 2003 in the US. While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Development Drugs Clinical Trials Clinical Trials 147

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 22, 2022

Five seriously ill lupus patients have seen their disease driven into remission after a single infusion of modified immune cells, in a small trial that borrows from cancer therapy to harness patients’ own cells to treat the autoimmune condition. Skip advert Scientists are calling the results “spectacular” and “incredibly exciting”, saying the findings may herald […].

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Trials Scientist Clinical Trials Clinical Trials 130

NPR Health - Shots

SEPTEMBER 20, 2022

Since 2020, office workers have waged an epic battle to work remotely. They're mostly winning.

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Bio Pharma Dive

SEPTEMBER 23, 2022

Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.

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Gene Therapy Gene Trials 230

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market. Much of the innovation in pharma pipelines is currently driven by smaller – or even virtual – companies.

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Manufacturing Drugs Production Development 147

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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.

Clinical Trials