AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 6, 2022

Major healthcare and technology companies are looking at exploring the market for artificial intelligence (AI) enabled devices and technologies in the healthcare market in India, according to experts. With the rise of AI and machine learning-focused healthtech startups in India, big companies are looking for opportunities to invest and expand their footprint in the country […].

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NPR Health - Shots

NOVEMBER 6, 2022

Millions of people are prescribed statins to lower cholesterol and reduce the risk of heart disease, but many would rather take supplements instead. A new study shows statins are much more effective.

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pharmaphorum

NOVEMBER 6, 2022

Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection. Lilly had already secured planning approval from Limerick City and County Council for the plant at the Raheen Business Park.

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NPR Health - Shots

NOVEMBER 6, 2022

An Indiana man's family sued a state-owned nursing home for alleged mistreatment. A U.S. Supreme Court decision in the case could determine the right of many Americans to sue government agencies.

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Nurses 132

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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

BioSpace

NOVEMBER 6, 2022

Eye specialist Oyster Point Pharma announced is being acquired by Viatris Inc. after Oyster’s board of directors unanimously signed off on the deal, Oyster Point announced Monday.

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NPR Health - Shots

NOVEMBER 6, 2022

She and her daughter carried one small suitcase for toiletries, clothes and shoes. But she made sure she had room for a few items with deep sentimental value.

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FDA Law Blog

NOVEMBER 6, 2022

By Sophia R. Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court.

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BioSpace

NOVEMBER 6, 2022

The only patient in an FDA-sanctioned clinical trial assessing a CRISPR-based therapy for a rare form of Duchenne muscular dystrophy has died, according to study sponsor Cure Rare Disease.

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Trials Clinical Trials Clinical Trials 92

JAMA Internal Medicine

NOVEMBER 6, 2022

This cohort study assesses the rate of recurrence of venous thromboembolism (VTE) in patients with COVID-19–associated VTE who discontinued anticoagulation therapy.

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BioSpace

NOVEMBER 6, 2022

GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.

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Trials 97

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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

Drug Patent Watch

NOVEMBER 6, 2022

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

NOVEMBER 6, 2022

Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.

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Drugs 82

Drug Patent Watch

NOVEMBER 6, 2022

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

NOVEMBER 6, 2022

Eli Lilly’s and Boehringer’s Jardiance met its primary outcome in the Phase III EMPA-KIDNEY study, the largest and broadest SGLT2 inhibitor trial in chronic kidney disease.

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Trials 71

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Drug Patent Watch

NOVEMBER 6, 2022

This chart shows the patent expirations for cream dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Cream dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 98

BioSpace

NOVEMBER 6, 2022

Salary transparency laws are becoming more popular across the U.S. Here are some tips to help you negotiate your pay when salary transparency has left you feeling underpaid.

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pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. The current mAbs market is expected to be around ~USD 150 billion. In 2021, five out of the top 10 selling drugs were mAbs and this trend is forecasted to remain the same over the next five years. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline.

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BioSpace

NOVEMBER 6, 2022

Biopharma's efforts to conquer immunoglobulin A nephropathy were on full display at ASN's Kidney Week as Ionis, Chinook and Vera all reported positive data.

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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

pharmaphorum

NOVEMBER 6, 2022

AstraZeneca and Sanofi have secured approval in the EU for Beyfortus, the first single-dose drug to protect newborns and infants from respiratory syncytial virus (RSV) infections. The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement.

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BioSpace

NOVEMBER 6, 2022

Six supplements commonly taken to improve heart health and lower high cholesterol were ineffective when compared to AstraZeneca’s Crestor (rosuvastatin) and placebo.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 6, 2022

Detecting cancer early before it spreads throughout the body can be lifesaving. This is why doctors recommend regular screening for several common cancer types, using a variety of methods. Colonoscopies, for example, screen for colon cancer, while mammograms screen for breast cancer. While important, getting all these tests done can be logistically challenging, expensive, and […].

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BioSpace

NOVEMBER 6, 2022

The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply

BioSpace

NOVEMBER 6, 2022

BioAge Labs, PTC Therapeutics, Biogen and others highlighted novel mechanisms targeting newer pathways in neurodegenerative diseases at the recent Discovery on Target meeting.

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