Sun.Oct 29, 2023

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Simply Being Told You Were Given Ketamine Could Be Enough to Treat Depression

AuroBlog - Aurous Healthcare Clinical Trials blog

For those with stubbornly resistant forms of severe depression, ketamine was looking more and more like a solution. Years of research has hinted at the dissociative anesthetic’s treatment potential where other medications failed, promising the benefits of electroshock therapy with far fewer risks.

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Embattled Researchers See Path Forward for Anti-CD47 Cancer Drugs

BioSpace

With recent high-profile failures, experts say safety concerns and a lack of diversification are hindering the field—but still hold out hope for an approval.

Research 119
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Adoption of eco-friendly designs in healthcare facilities is the need of the hour: Dr Vivek Desai

AuroBlog - Aurous Healthcare Clinical Trials blog

Adoption of eco-friendly designs in healthcare facilities and policy interventions to address shortage of skilled human resources in healthcare is the need of the hour, says Dr. Vivek Desai, founder and managing director, HOSMAC, a hospital planning, management and design consultancy firm.

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FDA Flags Off-Target Effects of Vertex, CRISPR’s Sickle Cell Therapy Ahead of Adcomm

BioSpace

In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Changes in Physician Electronic Health Record Use

JAMA Internal Medicine

This longitudinal cohort study measures changes in physician use of electronic health records and electronic messaging given the telemedicine expansion catalyzed by the COVID-19 pandemic.

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Coherus, Junshi Get FDA Approval for First Chinese PD-1 and NPC Treatment

BioSpace

Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.

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Psychedelics Poised for the Therapeutic Mainstream

BioSpace

With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.

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A Case of S1Q3T3—A Classic Nonspecific Electrocardiogram Finding

JAMA Internal Medicine

This case report describes a patient in their 40s with a history of end-stage kidney disease secondary to hypertension and diabetes who presented with fatigue, cough, weakness, and dyspnea on exertion and was subsequently diagnosed with acute disseminated cryptococcal infection.

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Otsuka’s Centanafadine Shows Promise in Phase III Pediatric ADHD Studies

BioSpace

The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.

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Decentralized Clinical Trials: The Future of Clinical Research

Roots Analysis

Over the past decade, the rise of this digital technology has transformed various sectors, from finance to healthcare. One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs).

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The New Age of Decentralized Clinical Trials

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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JLABS @ NYC Celebrates Its 5th Year in the Big Apple

BioSpace

JLABS @ NYC Celebrates Its 5th Year in the Big Apple - read this article along with other careers information, tips and advice on BioSpace

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Which pharmaceutical drugs have the most drug patents in Lithuania?

Drug Patent Watch

This chart shows the drugs with the most patents in Lithuania. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Lithuania? appeared first on DrugPatentWatch - Make Better Decisions.

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Novel Immune Modulator Has Potential to Change Treatment Approach in Rheumatoid Arthritis and Ulc.

BioSpace

A first-in-class clinical trial will initiate this quarter to determine if a checkpoint agonist can down-regulate activated T cells to help reduce inflammation and tissue damage in patients with moderate-to-severe ulcerative colitis (UC).

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The ACA Contraceptive Mandate (Part 2)

FDA Law Blog

By Michelle L. Butler — Just over two years ago, I wrote about the challenges with implementation of the contraceptive mandate in the Patient Protection and Affordable Care Act (ACA). You will recall that, despite the ACA, a 2019 HRSA Guideline , and guidance from the federal agencies responsible for enforcing the contraceptive coverage requirement of the ACA (the Departments), women seeking contraceptives that were not specifically identified on an FDA Birth Control Guide were encountering roa

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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