Sun.Oct 10, 2021

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Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up

BioSpace

?The decision is based on promising results from the Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer's patients.

Drugs 112
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Limbix’ digital therapeutic cuts depression symptoms in young people

pharmaphorum

Limbix is moving ahead with plans to file for FDA approval of its SparkRx digital therapeutic (DTx) for adolescents with symptoms of depression after reporting positive results in a clinical trial. SparkRx uses a programme of cognitive behavioural therapy (CBT) that is designed to be used alongside treatment by a clinician, and to provide a readily-available intervention for young people when access to interpersonal psychotherapy may be limited.

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GSK Continues to Switch Up Scenery in Advance of Upcoming Demerger

BioSpace

The scenery will continue to change for GlaxoSmithKline as the company’s planned demerger looms on the horizon. On Monday, GSK gave a glimpse of where the companies will call home post-split.

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Point-of-Care Ultrasound—Visually Satisfying Medicine or Evidence-Based Medicine?

JAMA Internal Medicine

Point-of-care ultrasonography (POCUS) is the use of ultrasonography by clinicians to augment the physical examination and guide clinical decision-making at the bedside. It has become the standard of care for most common bedside procedures. However, while endorsed by the American College of Physicians and the Society of Hospital Medicine, its use for diagnostic purposes is not as firmly grounded in evidence demonstrating net benefit on patient outcomes.

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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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Moving Quickly, Merck Submits COVID-19 Antiviral for FDA Approval

BioSpace

If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.

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Patients with kidney transplants more vulnerable to common, usually harmless bacterium

Scienmag

AUGUSTA, Ga. (Oct. 11, 2021) – It’s a pervasive bacterium found in soil and water that rarely causes disease, but a new national review of nocardia infection in people who have had a kidney transplant shows that when it occurs it most commonly causes pneumonia and brain abscess, and reminds their physicians to stay on the […].

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The unknown consequences of plastic’s legacy, found in seabirds around the world

Scienmag

Seabirds from Gough Island in the south Atlantic, Marion Island near Antarctica and the coasts of both Hawaii and Western Australia have a dangerous habit: eating plastic. Across 32 species of seabirds sampled from around the globe, an international team from 18 institutions in seven countries found that up to 52 % of the birds […].

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Qpex is Moving Quickly to Combat Antimicrobial Resistance

BioSpace

Antimicrobial-resistant pathogens may still be a bit off peoples’ radar, but the hard lessons learned from lack of preparation for the COVID-19 pandemic are clearly in the sights of Qpex.

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Hey Now! IQOS IQOS All Day (Just Not in the United States)

FDA Law Blog

By David B. Clissold — It seems that although FDA giveth, the ITC taketh away. IQOS is a tobacco heating system in which “heatsticks” (reconstituted tobacco blended with glycerin) are electrically heated to release nicotine-containing aerosol, but the tobacco is not combusted. Because IQOS was classified as a cigarette by FDA, it was required to have FDA marketing authorization before it could be marketed.

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Ensoma Taps Gene Therapy Leader as First CEO

BioSpace

After guiding BlueRock Therapeutics and its potential Parkinson’s disease stem cell therapy into the clinic and to a $1 billion acquisition by Bayer, Emile Nuwaysir is taking on gene therapy startup Ensoma as CEO.

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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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Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey

Scienmag

Many Americans are experiencing anxiety symptoms as a result of the pandemic. Yet, one in five say they won’t seek treatment for mental health conditions and others say they won’t get help until these symptoms take a toll in their lives. Credit: GeneSight Mental Health Monitor Many Americans are experiencing anxiety symptoms as a result […].

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Supernus Snags Parkinson’s-focused Adamas Pharmaceuticals in $400 Million Deal

BioSpace

Shares of Adamas Pharmaceuticals are up nearly 75% this morning after Supernus Pharmaceuticals announced it was acquiring the company and its Parkinson’s disease products.

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A new proposed scheme towards seamless detection of cutoff lows and preexisting troughs

Scienmag

Niigata, Japan- Cutoff lows are cold-core cyclones existing in the upper troposphere developing from precursory preexisting troughs that is ultimately cutoff from the connections with the polar source region, as shown in Image 1. It is typically identified as local minima of geopotential height fields in the 500-200-hPa range. Most cutoff lows have synoptic spatial […].

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FDA Greenlights Enzyvant Drug for Ultra-Rare Pediatric Disease

BioSpace

The incidence of congenital athymia is about 17 to 24 lives births each year in the U.S. The therapy is a one-time regenerative tissue-based therapy.

Drugs 97
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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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Flash FDA approval sends ChemoCentryx spiralling upwards

pharmaphorum

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. Avacopan will be launched as Tavneos in the coming weeks as a treatment for two forms of ANCA vasculitis – granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) – in combination with standard therapies.

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Protagonist Back in the Saddle with PV Drug as FDA Lifts Hold

BioSpace

Protagonist Therapeutics announced Monday morning that the FDA had removed the hold on PV drug candidate rusfertide, clearing the way for all trials to resume.

Drugs 95
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Ipsen appoints Mari Scheiffele as EVP and President, Specialty Care International

BioTech 365

Ipsen appoints Mari Scheiffele as EVP and President, Specialty Care International Ipsen appoints Mari Scheiffele as EVP and President, Specialty Care International PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today the appointment of Mari Scheiffele as EVP and … Continue reading →

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Idorsia Drug Flops in Fabry Disease, Program's Future Pending

BioSpace

?Its Phase III MODIFY study had hoped to find a positive effect of its oral substrate reduction therapy lucerastat on adult patients who have been diagnosed with Fabry disease.

Drugs 72
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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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Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey

BioTech 365

Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the … Continue reading →

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Pacira Adds Flexion's Zilretta to Non-Opioid Pipeline in $427 Million Deal

BioSpace

Zilretta is the first treatment approved by the U.S. FDA for OA knee pain that uses extended-release microsphere technology.

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OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual Scientific Meeting

BioTech 365

OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual Scientific Meeting OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual … Continue reading →

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Bagging a Job in Pharma: Tips and Tricks

BioSpace

Before we look at the tips and tricks that can help you bag a job in pharma, we should look at the complications that you might face when getting the job.

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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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Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease

BioTech 365

Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease Ad hoc announcement pursuant to Art.

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Clinical Catch-Up: October 4-8

BioSpace

Another busy week for clinical trial news. Here’s a look.

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CatalYm Presents Updated Tolerability and Preliminary Pharmacodynamics Data from GDF-15 Targeting First-in-Human Clinical Trial in Plenary Session at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics

BioTech 365

CatalYm Presents Updated Tolerability and Preliminary Pharmacodynamics Data from GDF-15 Targeting First-in-Human Clinical Trial in Plenary Session at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics CatalYm Presents Updated Tolerability and Preliminary Pharmacodynamics Data from GDF-15 Targeting First-in-Human Clinical Trial … Continue reading →

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Which pharmaceutical companies have the largest patent portfolios?

Drug Patent Watch

A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength of pharmaceutical firms is to compare their patent-counts. This chart…. The post Which pharmaceutical companies have the largest patent portfolios? appeared first on DrugPatentWatch - Make Better Decisions.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations

BioTech 365

Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations HANGZHOU, China, Oct.

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Senate Trims Massive Spending Bill, Snipping Out Biden’s Cancer-Ending Agency

BioSpace

Biden’s campaign trail promise to cure cancer is hanging in the balance as his plan for a new biomedical research agency is being axed from the Democrats’ social spending package.

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BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma in Australia

BioTech 365

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma in Australia BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma in Australia Marks BRUKINSA’s second approved indication in Australia, on the heels … Continue reading →

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BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma

BioTech 365

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma Marks BRUKINSA’s second approved indication in Australia, on the heels of its recent initial … Continue reading →

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.