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Recent Releases On Global Health
Lancet Commends U.K. All-Parliamentary Group on AIDS Call For HIV Drug Patent Pool
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Is Paperwork Suffocating British Clinical Research?
Concerns are being raised by a growing number of British academics that bureaucratic overload is stifling their ability to undertake clinical research, compromising the future of this activity in the UK, and ultimately doing patients a disservice. The issues are discussed in a Special Report in the August edition of The Lancet Oncology, written by freelance journalist Adrian Burton.
News of the day
Louisiana Senate Committee Narrowly Approves Provider 'Conscience' Bill
The Louisiana Senate Health and Welfare Committee on Wednesday approved a bill (H.B. 517) that would expand the ability of health care workers to refuse to provide services for moral or religious reasons, the Baton Rouge Advocate reports. The bill passed by a 3-2 vote after the addition of amendments to narrow the scope of the legislation. According to the Advocate, the bill would allow a medical worker to choose not to participate in any service "that violates his conscience," which it defines as a religious belief or moral conviction. Gov. Bobby Jindal (R) supports the legislation, as do conservative groups like the Louisiana Family Forum and the Louisiana Right to Life Federation. Several groups oppose the bill, including Planned Parenthood, the Forum for Equality, Louisiana Agenda for Children and the American Civil Liberties Union. ACLU of Louisiana"s Marjorie Esman said that the bill could "lead to all kinds of unintended consequences," based on assertions of moral and religious objections (Blum, Baton Rouge Advocate, 6/11).
Medical Devices

Mylan Receives FDA Approval For Additional Strength Of Generic Restoril(R)

Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan"s currently marketed 15 mg and 30 mg strengths of the product. Temazepam Capsules are the generic version of Mallinckrodt"s Restoril®, a sleep aid, which had total U.S. sales of approximately $6 million for the 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product. Currently, Mylan has 118 ANDAs pending FDA approval representing $82.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, which represent $16.7 billion in annual brand sales, according to IMS Health. Mylan Inc.


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