Sun.Mar 07, 2021

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Russia Engaging in Anti-Pfizer Disinformation Campaign to Boost Sales of Sputnik V, U.S. Alleges

BioSpace

The Russian government is attempting to cast a negative light on the COVID-19 vaccine developed by Pfizer and BioNTech, as well as other vaccines, in order to boost sales of its own vaccine, Sputnik V, the government charged.

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Helping people understand glaucoma with a mobile app

Scienmag

Free mobile app demystifies glaucoma – helping to explain symptoms, impact and treatment to patients and their families Credit: Allergan Researchers from City, University London, supported by Allergan Pharmaceuticals and Glaucoma UK, have today released the latest edition of an app to help people newly diagnosed with glaucoma. The launch coincides with World Glaucoma Week […].

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CytoDyn's Vyrologix Shortens Hospital Stays, Improves Survival in Severe COVID-19

BioSpace

As of yet, the findings from the late-stage trial have not been published, but CytoDyn said it is preparing a manuscript of the study data to submit to one or more major journals.

Trials 110
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Fish Consumption and Risk of Cardiovascular Disease or Mortality With or Without Vascular Disease

JAMA Internal Medicine

This analysis pools data from 4 large cohort studies conducted in 58 countries to assess whether associations of fish consumption with risk of cardiovascular disease or mortality differ between individuals with and individuals without vascular disease.

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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

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Seres to Discontinue Microbiome Cancer Clinical Program

BioSpace

Microbiome company Seres Therapeutics announced the discontinuation of its Phase Ib trial of SER-401, an orally delivered consortia of bacteria that was intended to boost the efficacy of checkpoint inhibitors in patients with metastatic melanoma.

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Virtual avatar coaching with community context for adult-child dyads

Scienmag

Virtual reality avatar-based coaching shows promise to increase access to and extend the reach of nutrition education programs to children at risk for obesity, according to the Journal of Nutrition Education and Behavior Credit: Journal of Nutrition Education and Behavior Philadelphia, March 8, 2021 – Virtual reality avatar-based coaching shows promise to increase access to […].

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New Lancet series shows mixed progress on maternal and child undernutrition in last decade

Scienmag

Series authors issue a call to action for fast-tracked funding to improve program coverage and quality service delivery which have been adversely affected by the COVID-19 crisis Credit: International Center for Equity in Health The Lancet today published the latest Series on Maternal and Child Undernutrition Progress, including three new papers that build upon findings […].

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Following AstraZeneca's Lead, Roche Pulls Checkpoint Inhibitor in Bladder Cancer

BioSpace

Roche announced it was voluntarily withdrawing the U.S. indication Tecentriq for in prior-platinum treated metastatic urothelial carcinoma (mUC) after failing to meet endpoints in confirmatory trials.

Trials 75
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New patent expiration for ASPEN drug ENJUVIA

Drug Patent Watch

Annual Drug Patent Expirations for ENJUVIA Enjuvia is a drug marketed by Aspen and is included in one NDA. There are two patents protecting this drug. This drug has seventeen…. The post New patent expiration for ASPEN drug ENJUVIA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Clinical Catch-Up: March 1-5

BioSpace

It was another busy week for clinical trial announcements. Here’s a look.

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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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Fish, Cardiovascular Disease, and Mortality

JAMA Internal Medicine

Fish and shellfish (hereafter referred to as fish) are major sources of the dietary long-chain ?-3 fatty acids eicosapentaenoic acid (20:5n-3) and docosahexaenoic acid (22:6n-3) and also contain other nutrients, such as vitamin D, riboflavin, iodine, calcium, phosphorus, magnesium, potassium, zinc, and iron. The summed results of observational studies of fish intake, randomized clinical trials of fish oil supplements, and associated mechanistic and experimental studies suggest that regular fish

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Merck's Fortunes Against COVID-19 Improve as Ridgeback Drug Shows Early Promise

BioSpace

Merck and Ridgeback Biotherapeutics announced preliminary results from Ridgeback’s Phase IIa trial of molnupiravir in COVID-19.

Drugs 75
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Investigating youth suicides among children involved with the welfare system

Scienmag

Youth with child welfare involvement are at an elevated risk for suicide but may benefit from suicide prevention interventions targeting health care settings and family-preservation Suicide is the second leading cause of death among youth aged 5 to 21 years in the United States. Between 2010 and 2019, suicide rates among this group increased 40%. […].

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Antibody Drug Fails to Beat Placebo in Trial for Rare Inflammatory Skin Condition

BioSpace

AnaptysBio started the week with some disappointing news for its lead antibody drug imsidolimab.

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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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Globalization of cancer clinical trials linked to lower enrollment of Black patients

Scienmag

For the drug approval process in the United States, investigators have been expanding clinical trials to sites outside the country. However, a new study indicates that this trend may be widening racial disparities in patient enrollment in cancer clinical trials. The study is published by Wiley early online in CANCER, a peer-reviewed journal of the […].

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Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer

BioTech 365

Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance … Continue reading →

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The Lundquist Institute out-licenses development of a synthetic lung surfactant formulation

Scienmag

Bill & Melinda Gates Medical Research Institute to develop formulation -AGREEMENT ADVANCES EVOLUTION OF SYNTHETIC LUNG SURFACTANTS TO TREAT RESPIRATORY DISTRESS SYNDROME IN PREMATURE INFANTS IN LOW- AND MIDDLE-INCOME COUNTRIES- LOS ANGELES (March 8, 2021) — The Lundquist Institute (TLI) and The Bill & Melinda Gates Medical Research Institute (Gates MRI) executed a license agreement […].

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Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

BioTech 365

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer SOUTH SAN FRANCISCO, Calif.

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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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Study suggests wearing a face mask during intense exercise is safe for healthy people

Scienmag

Wearing a protective face mask has only a modest effect on the ability of healthy people to do vigorous exercise, according to a study published today (Monday) in the European Respiratory Journal [1]. Researchers carried out detailed testing on breathing, heart activity and exercise performance in a group of 12 people while they were using […].

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Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus

BioTech 365

Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus Vifor Pharma and Cara Therapeutics announce U.S.

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Which pharmaceutical companies have the most drug patents in European Patent Office?

Drug Patent Watch

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

Drugs 52
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Masimo Monitoring Solutions Promote Newborn and Maternal Safety

BioTech 365

Masimo Monitoring Solutions Promote Newborn and Maternal Safety Masimo Monitoring Solutions Promote Newborn and Maternal Safety New Neonatal Study Adds to Body of Clinical Evidence Demonstrating Masimo SET® Pulse Oximetry’s Unique Ability to Improve Care NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) … Continue reading →

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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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Drug to treat hypoactive sexual desire disorder in women of ‘very limited use’

Scienmag

Drug approved by the US Food and Drug Administration now shown ineffective – participants preferred a placebo An independent analysis of the medical trials which formed the final basis of approval by the US Food and Drug Administration (FDA) strongly suggests the drug bremelanotide has very limited effectiveness as a treatment for hypoactive sexual desire […].

Drugs 75
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LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes

BioTech 365

LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes Leading Korean CRO using Vault eTMF, Vault CTMS, and Veeva SiteVault Free for increased … Continue reading →

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