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Bringing safe and effective cell therapies to the bedside

Article Abstract:

New rules to assess the safety and efficacy of human cell- and tissue-based products are the culmination of a multiyear, cooperative effort between the US government and the biotech industry. The Food and Drug Administration (FDA) new regulation strikes the right balance between safety and encouragement of the development of new experimental medicines for unmet needs.

Author: Preti, Robert A.
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2005
Science & research, Research, United States. Food and Drug Administration, Cellular therapy, Cell therapy

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Industry warily eyes new Medicare drug plan

Article Abstract:

A new subsection of Medicare, known as Part D, was launched under intense scrutiny on 1 January 2006. The regulations authored by the Centers for Medicaid and Medicare Service provide a roughly 3,000 Part D drug plans wide leeway in setting prices while each plan individually negotiates wholesale prices with manufacturers.

Author: Moran, Nuala
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
Government domestic functions, Administration of Public Health Programs, Health Care Financing Admin, United States. Centers for Medicare and Medicaid Services, Health policy, Medicare Part D

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Hedge funds gain edge by doubling biotech investment

Article Abstract:

Hedge funds have doubled their investment in biotech. Hedge funds have become increasingly popular with investors because it can use investment techniques not available to mutual funds that allow increased returns on investment while mitigating risks associated with biotech.

Author: Ransom, John
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
Sales & consumption, Financial management, Management investment, open-end, Company investment, Investments, Mutual fund industry, Hedge funds, Market size

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Subjects list: United States, Laws, regulations and rules, Biotechnology industry, Biotechnology industries, Government regulation
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