The Pharma Data

NOVEMBER 30, 2020

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. Vlad Coric , M.D.,

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The Pharma Data

DECEMBER 16, 2020

–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co.,

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). What is the regulatory landscape of medical cannabis?

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

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Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. The sponsor is the pharmaceutical company conducting the trial.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Nuance Pharma .

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

MARCH 2, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S.

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. The studies demonstrated that CABENUVA was as effective as continuing a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. TITUSVILLE, N.J. ,

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. FDA approval, and customary exceptions).

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The Pharma Data

OCTOBER 21, 2020

a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. BRIDGEWATER, N.J., and Canada.

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Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . appeared first on Drug Discovery World (DDW). References . 1: [link] . 2: [link] .

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The Pharma Data

JANUARY 5, 2021

Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. The Company plans to initiate a pivotal Phase 2/3 study for patients with Prader-Willi syndrome (“PWS”) in the second half of 2021 pending regulatory discussion with the U.S.

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The Pharma Data

OCTOBER 20, 2020

With drug resistance and safety concerns continuing to rise with currently available treatment options, oteseconazole has the potential to differentiate itself from the azole drugs considered standard of care, and be the first FDA approved drug to help women with RVVC who have been largely ignored for too long.”.

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The Pharma Data

NOVEMBER 4, 2020

District Court ruling in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to VASCEPA capsules in its initial triglyceride lowering indication. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 promotion of VASCEPA : As reported, the U.S.

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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The Pharma Data

DECEMBER 29, 2020

” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

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