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The future of mental health treatment: Zelquistinel’s role

Drug Target Review

Event-driven pharmacology Donello highlights the growing recognition of synaptic plasticity’s crucial role in the biology of depression. “We call this phenomenon ‘event-driven pharmacology.” This means the PD effects of synapse-targeted drugs can significantly outlast their PK.

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Fitusiran

New Drug Approvals

1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]

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Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 . View original content to download multimedia: [link].

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

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Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.

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Details of Adverse Event in AstraZeneca’s Vaccine Trial Still Unknown | 2020-10-15

The Pharma Data

More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. was paused after a single UK patient experienced a serious adverse event ( DID, Sept.

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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

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