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U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

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

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Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Sosei Group Forward-looking statements.

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Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute

The Pharma Data

Teva Branded Pharmaceutical Products R&D, Inc. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.

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Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. There are five categories, each containing five cannabis scientists.

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Collegium Reports Net Income of $11.3 Million in the Third Quarter of 2020

The Pharma Data

With these new exclusive and parity formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 92 million lives and will be in a parity position for approximately 22 million lives. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.