Sun.Jun 13, 2021

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Retinal Tissue Restored in Patients with Dry AMD, Heralding Paradigm Shift

BioSpace

Retinal tissue has been regrown in three patients with age-related macular degeneration with geographic atrophy or dry (atrophic) AMD in a Phase I/IIa study conducted by Lineage Cell Therapeutics.

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Are we genetically ‘grounded’?

Scienmag

Hebrew University identifies molecular factors that enable birds to fly, but keep the rest of us on terra firma Credit: Baruch Haimson For centuries, scientists, aeronautic designers and adventure-seekers have sought to replicate the qualities that allow birds to fly, namely wing-structure and balance. However, without an external mechanism such as a hot air balloon […].

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Study Identifies Mechanisms Underlying Cognitive Impairment in COVID-19 Long-Haulers

BioSpace

Investigators from the Cleveland Clinic assessed possible relationships between COVID-19 and neuroinflammation and brain microvascular injury – two hallmarks of AD.

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Ibuprofen and other NSAIDs superior to codeine for managing outpatient postoperative pain

Scienmag

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen provide better pain control and have fewer adverse effects than codeine, a commonly prescribed opioid, when prescribed after outpatient surgery, according to new research published in CMAJ (Canadian Medical Association Journal) [link] “In all surgery types, subgroups and outcome time points, NSAIDs were equal or superior to codeine […].

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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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Flagship Pioneering Takes Aim at Global Health Threats with $3.37 Billion Fund

BioSpace

?Flagship Pioneering announced a massive cash infusion to support the development and launch of new companies aiming at various diseases and global health threats.

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Fashion for pointy shoes unleashed plague of bunions in medieval Britain

Scienmag

Credit: Jenna Dittmar The British have suffered for their fashion for centuries according to a new study suggesting that a vogue for shoes with a pointed tip led to a sharp increase in hallux valgus of the big toe – often called bunions – in the late medieval period. Researchers investigating remains in Cambridge, UK, […].

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New super-resolution technique allows for more detailed brain imaging

Scienmag

Credit: Image created by Y Chemli, et al., Gordon Center for Medical Imaging: Department of Radiology Massachusetts General Hospital, Harvard Medical School, Boston, MA. Reston, VA (Embargoed until 5:00 p.m. EDT, Sunday, June 13, 2021) – A new imaging technique has the potential to detect neurological disorders–such as Alzheimer’s disease–at their earliest stages, enabling physicians […].

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GSK Inks Potential $1.4 Billion Oncology Deal With Belgium-Based iTeos

BioSpace

Shares of iTeos Therapeutics skyrocketed more than 50% in premarket trading after it struck an agreement with GSM to co-develop and commercialize a cancer treatment.

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Business Development For Clinical Research Sites and Job Seekers in a Post COVID19 World

Clinical Trial Gurus

COVID-19 has changed the way clinical research sites look for studies. In addition, job seekers are also scrambling to find strategies for further developing their career pathways. In this webinar, Chris and myself share some pragmatic approaches for all to implement in order to take advantage of a HOT clinical trials industry!

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Enochian BioSciences Aims to Advance HIV Treatment That Could Provide Functional Cure

BioSpace

The FDA accepted its pre-Investigational New Drug request for a cell therapy treatment that could be a key factor in controlling HIV.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Barks in the night lead to the discovery of new species

Scienmag

The raucous calls of tree hyraxes — small, herbivorous mammals — reverberate through the night in the forests of West and Central Africa, but their sound differs depending on the location. Tree hyraxes living between the Volta and Niger rivers make a barking call that is distinct from the shrieking vocalizations of hyraxes inhabiting other […].

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Novavax’s COVID-19 Vaccine is 90.4% Effective, According to New Study Findings

BioSpace

The study also found the vaccine was 100% effective at preventing moderate and severe disease.

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Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

BioTech 365

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in … Continue reading →

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Clinical Catch-Up: June 7-11

BioSpace

A busy week for clinical trial news as the ASCO meeting wrapped up and the European Hematology Association 2021 Virtual Congress began. Read on for more.

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The New Age of Decentralized Clinical Trials

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.

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Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021

BioTech 365

Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021 Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021 Marseille, France, June 14, 2021 (GLOBE NEWSWIRE) — Pursuant to the article … Continue reading →

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FDA Action Alert: Blueprint, Orphazyme and Eton

BioSpace

The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.

Drugs 68
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Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021

BioTech 365

Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021 Number of Shares and Voting Rights of Innate Pharma as of June 1, 2021 MARSEILLE, France, June 14, 2021 (GLOBE NEWSWIRE) — Pursuant to the article … Continue reading →

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Janssen Hits Two Phase III Marks in Hematology Presentations at EHA

BioSpace

?Janssen presented the Phase III Glow study for the elderly with CLL or SLL and the overall survival results from the Phase III MAIA study for patients with NDMM.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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TILT Biotherapeutics Submits IND for Phase I Trial of Immunotherapeutic TILT-123 in Ovarian Cancer

BioTech 365

TILT Biotherapeutics Submits IND for Phase I Trial of Immunotherapeutic TILT-123 in Ovarian Cancer TILT Biotherapeutics Submits IND for Phase I Trial of Immunotherapeutic TILT-123 in Ovarian Cancer Pharma veteran, and TILT board advisor, Jyrki Liljeroos appointed as Chairman Swedbank … Continue reading →

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FDA Once Again Rejects Avenue Therapeutics’ NDA for IV Non-Opioid Painkiller

BioSpace

The FDA stated that the unpredictable and delayed analgesia onset with the intravenous therapy could not support a benefit when given alone to manage acute pain.

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RAPT Therapeutics to Report Top Line Data from Phase 1b Trial of RPT193 in Atopic Dermatitis

BioTech 365

RAPT Therapeutics to Report Top Line Data from Phase 1b Trial of RPT193 in Atopic Dermatitis RAPT Therapeutics to Report Top Line Data from Phase 1b Trial of RPT193 in Atopic Dermatitis SOUTH SAN FRANCISCO, Calif.

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Which pharmaceutical drugs have the most drug patents in Serbia?

Drug Patent Watch

This chart shows the drugs with the most patents in Serbia. 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 Serbia? appeared first on DrugPatentWatch - Make Better Decisions.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Terns Pharmaceuticals to Host Conference Call to Discuss Top-line Results from Phase 2a LIFT Study of TERN-101 for Treatment of NASH

BioTech 365

Terns Pharmaceuticals to Host Conference Call to Discuss Top-line Results from Phase 2a LIFT Study of TERN-101 for Treatment of NASH Terns Pharmaceuticals to Host Conference Call to Discuss Top-line Results from Phase 2a LIFT Study of TERN-101 for Treatment … Continue reading →

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