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Coya Therapeutics expands COYA 301 patent estate

Pharmaceutical Technology

Coya Therapeutics has expanded its patent estate for COYA 301 by entering a licensing agreement with UNeMed, the University of Nebraska Medical Center’s technology transfer office. This suggests that the interventional strategy may lead to sustained suppressive immune responses and neuroprotection in PD.

In-Vivo 130
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South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

In the Phase II trials, adult participants received a single Nuvaxovid booster dose six months after their initial two-dose vaccine doses. The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials.

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AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. The two companies are also running a phase 3 trial of the bispecific as a monotherapy in patients with relapsed/refractory diffuse LBCL.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

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Kaiser Permanente Joins Late-Stage Trial for Pfizer and BioNTech’s Lead COVID-19 Vaccine Candidate

XTalks

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.