Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: Working in a pharmaceutical company is the best way to learn this. A: This does not usually happen.

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The Pharma Data

JANUARY 10, 2021

Sébastien Peltier, CEO of VALBIOTIS, and Jocelyn Pineau, CFO, are taking part in this key event for biotechnology and pharmaceutical companies. Its products are intended to be licensed to players in the health sector. The Company has established three sites in France: Périgny, La Rochelle (17) and Riom (63).

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The Pharma Data

JANUARY 19, 2021

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. The FTD is designed to make important new drugs accessible to patients faster.

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The Pharma Data

JANUARY 5, 2021

” Dr. Strong added, “We have played an active and instrumental role with pharmaceutical companies through the engagement of the PWS community, support of innovative research programs, and creation of PWS research tools and clinical trial endpoints.” Theresa Strong, Ph.D., ” Clinical Highlights.

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The Pharma Data

OCTOBER 14, 2020

is a pharmaceutical company conducting business in more than 70 countries around the world. Established in 2017, iota is a start-up company focused on building a foundation for the future of bioelectronic medicine. iota holds exclusive licenses to technologies developed at leading U.S. About Astellas. Astellas Pharma Inc.

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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. About Collegium Pharmaceutical, Inc.

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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. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protalix has licensed to Pfizer Inc. About Fabry Disease.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

DECEMBER 15, 2020

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression.

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FDA Approval Treatment RNA FDA 52

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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The Pharma Data

MARCH 4, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. About Takeda Pharmaceutical Company Limited. A replay of the call will be available on the Ovid Therapeutics website following the completion of the call and will be archived for 30 days.

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Treatment Clinical Trials Pharmaceutical Companies Trials 52

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss. “I

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Drug Development Disease Therapies Engineering 52

The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. Toronto, Ontario–(Newsfile Corp.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. American Cancer Society.

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The Pharma Data

MAY 8, 2021

The Company continues to work with other healthcare authorities and regulators around the world to ensure this information is included in product labels for the Company’s COVID-19 vaccine. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

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DrugBank

DECEMBER 4, 2024

  IPR, while essential for incentivizing innovation, can also restrict access to medicines by granting pharmaceutical companies monopolies on their products. Still, it also provides flexibilities, such as compulsory licensing and parallel importation, that LMIC can utilize to improve access to medicines.

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The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Securities and Exchange Commission Regulation G. Licensing and royalty revenue. million and $8.9 million and $5.7 million and $1.1 million and $346.5 million and $227.6

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Production Trials FDA Disease 40

The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc.

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FDA Approval Treatment FDA Pharmaceutical Companies 52

Codon

APRIL 24, 2025

While China’s AI competitiveness may have blindsided the tech world, the pharmaceutical industry has already had quite a few “ DeepSeek Moments ” of its own. “Today, they’re just as likely to license a molecule from a Chinese company. regulators hoping to speed up drug development, too.

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Drug Patent Watch

DECEMBER 19, 2024

As companies invest billions in research and development, protecting their innovations through strategic patent management has become more important than ever. This comprehensive guide will explore how pharmaceutical companies can leverage their drug patent portfolios to maximize value, maintain market dominance, and drive innovation.

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Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills.

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The Pharma Data

SEPTEMBER 8, 2020

About the Janssen Pharmaceutical Companies of. We’re the Pharmaceutical Companies of. D “Risk Factors” in the company’s Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.

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The Pharma Data

SEPTEMBER 8, 2020

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission.

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. People are hesitant to do this because it's not a particularly flashy disease to research, nor is this population the focus of major pharmaceutical companies.

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The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. In short, the advisory committee did not vote to recommend the drug to the agency, which has a PDUFA date of March 7, 2021 to decide whether to approve the aducanumab Biologics License Application (BLA).

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

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