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Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks.

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Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

FDA Law Blog: Biosimilars

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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Analysis Chemical Thank You The 103 regulations the EPA is currently working on

Agency IQ

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Article EMA Thank You What you need to know about the status of the proposed EMA fees regulation

Agency IQ

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Can Europe become a major player in cell and gene therapy?

Drug Discovery World

A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment, particularly when it comes to Advanced Therapies Medicinal Products (ATMPs) like tissue, gene and cell therapies. .

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Could NfL accelerate drug development for neurodegenerative diseases?

Drug Discovery World

The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed. These factors have made regulators reluctant to rely on NfL in benefit-risk assessments of new therapies. 2019 Aug;11(15):1405-1418. doi: 10.4155/bio-2019-0163. Epub 2019 Aug 12.

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Europe: Where is the drug discovery innovation?

Drug Discovery World

Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany. Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) spent €41.5

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