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 110

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.

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Regulation 342

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.

Genome 342

Genome Genomics 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 […].

Clinical Trials 177

Clinical Trials Clinical Trials Clinical Research Trials 177

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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.

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Trials Clinical Trials Clinical Trials Development 246

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 358

Gene Therapy FDA Approval Gene Production 358

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 162

Rethinking Clinical Trials

SEPTEMBER 21, 2022

Dr. Margarat McConnell. In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “ Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern.

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Nurses Clinical Trials Clinical Trials Trials 130

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.

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Gene Therapy Gene Research 323

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 Vaccination Vaccine 279

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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

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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

Worldwide Clinical Trials

SEPTEMBER 19, 2022

Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder , substance use disorder , and post-traumatic stress disorder , has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that a

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Trials Clinical Trials Clinical Trials Clinical Research 130

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 311

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

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.

Trials 145

Trials Genetics Vaccination Vaccine 145

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.

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Genome Project Genome Genomics Scientist 138

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.

Marketing 278

Marketing 278

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 Vaccination Vaccine 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

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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STAT News

SEPTEMBER 21, 2022

The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their liver last year, another six patients with a different strand of toxic liver DNA knocked out last week.   The next era of CRISPR may not be so smooth.

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Gene Editing Gene DNA Research 128

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 286

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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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

Clinical Research

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

STAT News

SEPTEMBER 22, 2022

Over the last six years, a venture capital team run out of pharmaceutical giant Bayer invested roughly $1.5 billion into small biotech startups. Now, it’s ramping up. The firm plans to invest a nearly identical pot of money — this time, $1.3 billion — in half the time.

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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 228

Pharmaceutical Technology

SEPTEMBER 22, 2022

GSK has signed an exclusive licence agreement with Spero Therapeutics for the latter’s tebipenem pivoxil hydrobromide (tebipenem HBr) treatment for complicated urinary tract infections (cUTI). A late-stage asset of Spero, tebipenem HBr is being developed as the first oral carbapenem antibiotic to treat cUTIs, including pyelonephritis, which are caused by specific bacteria.

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Bacteria Marketing Trials Clinical 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

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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STAT News

SEPTEMBER 21, 2022

TORONTO — The Finks, married just a month earlier, sat down for their appointment, Kim dressed in head-to-toe pink and Chris in all black. He was taciturn, while she joked she couldn’t stop talking long enough to have her blood pressure taken. Jouvence Tshiyoyo Bukumba, a nurse, asked Kim, 46, about her cardiology appointment and Chris, 54, about his nerve pain.

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Cardiology Nurses 119

Bio Pharma Dive

SEPTEMBER 19, 2022

The French company, still aiming to rebound from a Phase 3 study failure two years ago, will pay about $41 million for Versantis and its experimental liver disease drugs.

Drugs 208

Drugs 208

Pharmaceutical Technology

SEPTEMBER 22, 2022

Avrobio has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. AVR-RD-04 works by genetically modify a patient's hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein.

Gene Therapy 147

Gene Therapy Gene Protein Clinical Trials 147

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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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