Remove Immune Response Remove Pharmacokinetics Remove Vaccine
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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

The Pharma Data

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

Cell and gene therapy products, adjuvanted vaccines, and blood products all fall outside the scope. Finally, in either scenario, sponsors should consider adverse effects directly related to the product’s interaction with a biological component of the immune system (e.g.,

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Sanofi Speeds Up Beyfortus Shipments Ahead of 2025-2026 RSV Season

The Pharma Data

According to Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, the product has been administered to over 250,000 infants in real-world settings, backed by more than 40 studies demonstrating its effectiveness in preventing RSV lower respiratory tract disease.

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New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable

The Pharma Data

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases. TREMFYA was approved in the U.S.

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Tiziana Life Sciences plc announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in Brazil

The Pharma Data

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected. A further announcement will be made in due course. In a humanized mouse model (NOD/SCID IL2?c-/-),

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Nanotechnology in Drug Delivery

DrugBank

Conversely, conjugation involves chemically attaching the drug to the nanoparticle surface, allowing for targeted delivery and improved pharmacokinetics. Nanoparticles are being explored as innovative carriers for antibiotics, antivirals, and vaccines, with the potential to significantly enhance their effectiveness.

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Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19. Regarding vaccination status: The new document expands upon a previously simple recommendation to determine vaccination status for patients enrolled in clinical trials.

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