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FDA warns of deadly results of skin-numbing creams

The U.S. Food and Drug Administration (FDA) has issued a warning about topical anesthetics that have skin-numbing effects.

7 Feb 2007

Research helps explain origin of self-reactive B cells

Doctors have long wondered why, in some people, the immune system turns against parts of the body it is designed to protect, leading to autoimmune disease.

7 Feb 2007

ViroPharma receives orphan drug designation for Maribavir

ViroPharma Incorporated today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for maribavir for prevention of cytomegalovirus (CMV) viremia and disease in the populations at-risk.

7 Feb 2007

WHO cautions Thailand against issuing compulsory license for antiretroviral Kaletra

The World Health Organization on Thursday cautioned the Thai government on its decision to allow the country to produce a lower-cost version of Abbott Laboratories' antiretroviral drug Kaletra by granting a compulsory license for the drug, the Bangkok Post reports.

7 Feb 2007

Canadian prescription drugs still being seized in U.S.

At least 37 packages of prescription drugs from Canada were seized by federal officials in South Florida, despite a federal government promise in October 2006 to stop confiscating drugs imported for personal use, the South Florida Sun-Sentinel reports.

7 Feb 2007

Ban called for on newer birth control pills

The advocacy group Public Citizen has filed a petition with the Food and Drug Administration (FDA) demanding that the sale of some of the newer birth control pills be banned.

6 Feb 2007

Ranbaxy and GlaxoSmithKline form alliance

Ranbaxy Laboratories announced today that the Company and GlaxoSmithKline have signed a new, multiyear R&D agreement that modifies and expands the terms of their strategic alliance established in 2003 to provide Ranbaxy expanded drug-development responsibilities and further financial opportunities.

6 Feb 2007

Many low-income Medicare beneficiaries receive no help from PAPs

Many low-income Medicare beneficiaries enrolled in the prescription drug benefit receive no help from patient assistance programs operated by pharmaceutical companies, according to advocacy groups, USA Today reports.

6 Feb 2007

FDA efforts to improve prescription drug safety encouraging

FDA is "making encouraging moves to strengthen its regulation of drugs that are already on the market," but the "changes fall far short of what's needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use," a New York Times editorial states.

6 Feb 2007

Alphanate approved to treat Von Willebrand disease

The U.S. Food and Drug Administration (FDA) has announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate.

4 Feb 2007

FDA and VA to share information on safe use of medical products

The U.S. Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) in the U.S. Department of Veterans Affairs (VA) announced today that they have signed a memorandum of understanding (MOU) to share information and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices (medical products).

30 Jan 2007

FDA commits to safety

The U.S. Food and Drug Administration (FDA) today outlined a comprehensive commitment to the safety of drugs and other medical products.

30 Jan 2007

Merck lobbying States to mandate Gardasil for school girls

Merck recently has been providing lobbyists throughout the country with information about its human papillomavirus vaccine Gardasil in an effort to encourage states to mandate that middle-school age girls receive it, the Baltimore Sun reports.

30 Jan 2007

Utah Senate approves bill to establish Medicaid preferred drugs

The Utah Senate on Wednesday unanimously approved a bill (SB 42) that would establish a preferred drug list for the state Medicaid program, the Deseret Morning News reports.

30 Jan 2007

Drug giant Wyeth loses another HRT trial to the tune of $1.5 million

Drug giant Wyeth has been ordered by a court in Philadelphia to pay $1 million in compensation to a woman who developed breast cancer after taking the hormone replacement therapy (HRT) Prempro.

30 Jan 2007

Thailand the latest drug patent buster

Thailand's military government has used World Trade Organization (WTO) rules regarding intellectual property, to allow the sale of generic versions of two important drugs used to treat HIV/AIDS and heart disease.

29 Jan 2007

GlaxoSmithKline's new influenza vaccine accepted for review in Europe

GlaxoSmithKline has announced that its new generation H5N1 split antigen pre-pandemic influenza vaccine has been accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe.

29 Jan 2007

Panel recommends FDA to not create specific effectiveness standard for oral contraceptive approvals

A panel of gynecologists, researchers and other medical experts on Wednesday at the end of a two-day meeting convened by FDA recommended the agency not set a specific standard of effectiveness for approval of oral contraceptives, the AP/Minneapolis Star Tribune reports.

28 Jan 2007

More med schools, hospitals ban gifts from pharmaceutical companies

An increased number of U.S. medical schools and hospitals have begun to ban meals and other gifts from pharmaceutical companies to physicians, residents and medical students "in response to concerns about whether the pharmaceutical industry's expensive marketing efforts influence which drugs doctors prescribe and whether those costs get passed on to patients.

23 Jan 2007

House Ways and Means Health Subcommittee will make Medicare prescription drug benefit oversight priority in 2007

The House Ways and Means Subcommittee on Health will examine oversight of the Medicare prescription drug benefit among other priorities for the 110th Congress, House Ways and Means Committee Chair Charles Rangel (D-N.Y.) and ranking member Jim McCrery (R-La.) wrote in a letter sent last Wednesday to leaders of the House Oversight and Government Reform Committee and the House Administration Committee, CQ HealthBeat reports.

23 Jan 2007