article thumbnail

Symbiotica and Quidel Score FDA Authorizations for COVID-19 Tests

XTalks

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

Antibody 102
article thumbnail

Patient Safety and Radiopharmaceuticals Administration: Minimizing Radiation Exposure and Risks

Worldwide Clinical Trials

Radiolabeled Antibodies : Various antibodies are being radiolabeled to target specific cancer antigens, enhancing both diagnostic accuracy and therapeutic efficacy. It provides guidelines, training, and technical support to member states to enhance radiation safety practices, including the use of radiopharmaceuticals.

Hormones 130
Insiders

Sign Up for our Newsletter

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

article thumbnail

Ezra Receives FDA Clearance For Prostate Cancer Artificial Intelligence

The Pharma Data

To integrate Prostate AI into radiology workflows, Ezra has also obtained FDA clearance for Plexo, a cloud-based PACS (Picture Archiving and Communications System) that works directly in the browser. This means that radiologists can now log onto the Ezra platform and use the AI without the need to install any software.

article thumbnail

Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

Meanwhile, Novartis has secured European approval for a subcutaneous formulation of the anti-CD20 antibody ofatumumab for relapsing forms of multiple sclerosis (RMS) under the Kesimpta brand name. . “We believe this technology has the potential to transform many patients’ lives,” she added. Kesimpta approval in Europe.

article thumbnail

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

The Pharma Data

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

article thumbnail

Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Vornov, nusinersen is driving much of what is being currently seen in drug development.

Trials 83
article thumbnail

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

The Pharma Data

Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine. PSMA-TTC, which is combining a prostate-specific membrane antigen (PSMA)-targeting antibody with thorium-227, is a leading TTC project at Bayer.