Sun.Aug 22, 2021

article thumbnail

Starpharma's Nasal Spray Reduces SARS-CoV-2 by Over 99.9% in Animal Studies

BioSpace

?Starpharma's Viraleze has reduced the viral load by over 99.9% when it was administered nasally into the trachea and lungs of animals who were positive with the virus, compared to saline control.

110
110
article thumbnail

FDA issues warning on robot-assisted breast cancer surgery

pharmaphorum

The FDA has issued a safety alert about the use of robot-assisted surgical (RAS) devices for use in mastectomy procedures, pointing out that their safety and efficacy have not been established. The move comes amid reports that some people are being offered RAS for the prevention or treatment of breast cancer, sometimes as part of a clinical trial, even though many of the studies are being undertaken “without the FDA oversight required.” RAS devices – which enable surgeons to use comp

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Says “Stop It” to Self-Medicating for COVID-19 with Unapproved Treatments

BioSpace

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the FDA’s recently tweeted advice to Americans seeking out alternative, unapproved treatments for COVID-19.

102
102
article thumbnail

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

pharmaphorum

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who have had their cancer treated with surgery but are considered at risk of the disease coming back.

article thumbnail

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

article thumbnail

Anti-Aging Foundation Terminates de Grey After Alleged Attempt to Influence Investigation

BioSpace

Anti-aging organization SENS Research Foundation sacked Chief Science Officer Aubrey de Grey over concerns he has attempted to influence an investigation of sexual harassment claims filed against him.

Research 102
article thumbnail

COVID-19 Transmission Dynamics Among Close Contacts of Index Patients

JAMA Internal Medicine

This cohort study evaluates the association between the timing of exposure to and severity of COVID-19 disease in close contacts of index patients with COVID-19.

77

More Trending

article thumbnail

AZ’s Alexion takeover hits a snag, as Ultomiris flunks ALS trial

pharmaphorum

It has only been a month since AstraZeneca’s $39 billion takeover of Alexion was completed, but the merger has already had a setback. Alexion has dropped development of its Ultomiris drug in amyotrophic lateral sclerosis (ALS), chalking up the first clinical failure for the drug since AZ took control. The phase 3 CHAMPION-ALS trial showed that Ultomiris (ravulizumab) was unable to move the needle on ALS symptoms at an interim readout of the data, and AZ has decided to discontinue developme

Trials 59
article thumbnail

Genevant, Takeda Enter Collab to Find a Cure for Rare Liver Diseases

BioSpace

?Genevant Sciences has announced a collaboration deal with Takeda Pharmaceutical to create and commercialize new therapies to treat two undisclosed types of rare liver diseases.

98
article thumbnail

Can a heartburn drug help doctors treat COVID-19?

The Pharma Data

In the early days of the COVID-19 pandemic, doctors in Wuhan noticed something surprising. Many of the elderly patients who survived the virus were poor: not exactly the demographic you would expect to fare well in a health crisis. A review of the survivors’ medical records revealed that a significant number suffered from chronic heartburn and were taking an inexpensive drug called famotidine, the key ingredient in Pepcid.

Doctors 52
article thumbnail

COVID-19 Booster Shots, the Flu and You

BioSpace

While last flu season saw fears of a “twindemic” go largely unfounded, there are fears that recent lockdowns could also lead to a lack of natural immunity against the flu.

98
article thumbnail

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.

article thumbnail

Leslie A. Brun Resigns from Merck Board of Directors

The Pharma Data

MSD outside the United States and Canada, announced today that Leslie A. Brun, its independent lead director, has resigned from its Board of Directors, effective August 19, 2021. Mr. Brun is stepping down due to his decision to become chairman and chief executive officer of Ariel Alternatives, LLC, a subsidiary of Ariel Investments, LLC, a private equity initiative being created to help scale minority-owned businesses to serve as tier 1 suppliers to Fortune 500 companies.

52
article thumbnail

Prominent Whitehead Institute Cell Biologist Terminated for Sexual Harassment

BioSpace

David Sabatini had initially been suspended from his position, but following the conclusion of the investigation, he was terminated over the weekend.

98
article thumbnail

Update on CHAMPION-ALS Phase III trial of Ultomiris in amyotrophic.

The Pharma Data

Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that the trial be discontinued due to lack of efficacy.

Trials 52
article thumbnail

FDA Fully Approves First COVID-19 Vaccine

BioSpace

Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.

article thumbnail

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.

article thumbnail

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

In CheckMate -274, Opdivo nearly doubled median disease-free survival compared to placebo in the intent-to-treat population 1. Opdivo is now approved in earlier stages of disease for three types of cancer, including the first and only PD-1 inhibitor approved for urothelial carcinoma in the adjuvant setting. today announced that Opdivo ® (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S.

Drugs 52
article thumbnail

Pondering a Potential Link Between COVID-19 and Alzheimer's Disease

BioSpace

Research presented earlier this month discussed a possible link between COVID-19 and long-term cognitive deficits and how it may accelerate the pathology and symptoms of Alzheimer’s disease.

article thumbnail

Sugars from human milk could help treat, prevent infections in newborns

Scienmag

Bacteria known as group B Streptococcus (GBS) are a common cause of blood infections, meningitis and stillbirth in newborns. Although GBS infections can often be treated or prevented with antibiotics, the bacteria are becoming increasingly resistant. Now, researchers have discovered that human milk oligosaccharides (HMOs) –– short strings of sugar molecules abundant in breast milk […].

article thumbnail

FDA Action Alert: Cara/Vifor, Kadmon, BMS, Merck/Eisai

BioSpace

The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.

98
article thumbnail

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.

article thumbnail

Rare Cambrian fossils from Utah reveal unexpected anatomical complexity in early comb jellies

Scienmag

Ctenophores, also known as comb jellies, are a group of over 200 living species of invertebrate animals with a transparent gelatinous body superficially resembling that of a jellyfish. There is much interest in ctenophore evolution in recent years as their controversial phylogenetic position in the animal tree of life has prompted conflicting hypotheses.

52
article thumbnail

Pfizer Bets $2.26 Billion on Trillium's Checkpoint Inhibitors

BioSpace

?Under the terms of the deal, Pfizer is picking up all outstanding shares of Trillium that it doesn’t already own for $18.50 per share in cash.

76
article thumbnail

Cross Reference Regulatory Documents and Logs In Clinical Research Investigator Site File

Clinical Trial Gurus

Regulatory documents are essential for every clinical trial. As a clinical research coordinator or clinical research associate it can be helpful to know which documents typically cause cascades for other documents.

article thumbnail

Clinical Catch-Up: August 16-20

BioSpace

It was another busy week in clinical trial news. Here’s a look.

article thumbnail

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.

article thumbnail

Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine

BioTech 365

Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine Saint-Herblain (France), August 23, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine … Continue reading →

article thumbnail

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.

article thumbnail

Allarity Therapeutics Publishes Interim Report for the Period January – June 2021

BioTech 365

Allarity Therapeutics Publishes Interim Report for the Period January – June 2021 Allarity Therapeutics Publishes Interim Report for the Period January – June 2021 Press Release Hørsholm, Denmark (August 23, 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today … Continue reading →

40
article thumbnail

Which pharmaceutical drugs have the most drug patents in Denmark?

Drug Patent Watch

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

Drugs 98
article thumbnail

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.

article thumbnail

Bavarian Nordic Initiates Phase 2 Clinical Trial of COVID-19 Booster Vaccine

BioTech 365

Bavarian Nordic Initiates Phase 2 Clinical Trial of COVID-19 Booster Vaccine Bavarian Nordic Initiates Phase 2 Clinical Trial of COVID-19 Booster Vaccine Phase 2 trial will investigate vaccine’s ability to boost existing immunity from prior COVID-19 vaccination or disease Immune … Continue reading →

article thumbnail

Teva Announces Post Hoc Analysis of Long-Term Data Examining Treatment.

The Pharma Data

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a post hoc analysis of a long-term, 3-year open-label extension (OLE) study examining efficacy and safety endpoints for the use of AUSTEDO (deutetrabenazine) tablets in younger (<55 years) and older (?55 years) patients with tardive dyskinesia (TD).

article thumbnail

New Study Evaluates the Use of Masimo PVi® to Monitor Volume Status in Spontaneously Breathing Hemodialysis Patients

BioTech 365

New Study Evaluates the Use of Masimo PVi® to Monitor Volume Status in Spontaneously Breathing Hemodialysis Patients New Study Evaluates the Use of Masimo PVi® to Monitor Volume Status in Spontaneously Breathing Hemodialysis Patients NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced … Continue reading →

52
article thumbnail

XELJANZ® (TOFACITINIB CITRATE) RECEIVES MARKETING AUTHORIZATION IN THE EUROPEAN UNION.

The Pharma Data

today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Two formulations were approved, a tablet and a new oral solution (weight-based dosing).

article thumbnail

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.