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Calls for tougher rules on complementary medicines in Australia

Pressure from a consumer group has prompted the Australian Federal Government to consider the introduction of far more stringent disclosure rules regarding complementary medicines.

10 Jun 2008

Administration proposes additional funding for FDA for fiscal year (FY) 2009

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

9 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

Cancer warning on diabetic ulcer gel

The U.S. watchdog the Food and Drug Administration (FDA) says a warning will be added to the label of a topical gel used to treat leg and foot ulcers which refuse to heal in diabetic patients.

9 Jun 2008

Nearly 75% of Medicare drug plan beneficiaries will pay 16% more for coverage this year

Monthly premiums for Medicare beneficiaries enrolled in the 10 largest prescription drug plans this year increased by an average of 16% to $26.39, according to an analysis released on Wednesday by Avalere Health, the Los Angeles Times reports.

8 Jun 2008

Boehringer, Gilead freeze antiretroviral prices for some U.S. agencies

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports.

8 Jun 2008

GlaxoSmithKline Acquires Sirtris Pharmaceuticals

GlaxoSmithKline has announced that it has completed its acquisition of Sirtris Pharmaceuticals, Inc. (Sirtris) for approximately USD720 million (or approx. GBP362 million) through a cash tender offer and merger of USD22.50 (or approx. GBP11.33) per share.

8 Jun 2008

FDA announces label changes for Regranex - boxed warning

The U.S. Food and Drug Administration has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

8 Jun 2008

New invaluable tool in drug manufacture

Drug companies could save millions thanks to a new technology to monitor crystals as they form.

8 Jun 2008

Arthritis drugs used in children to be investigated because of cancer link

Authorities in the United States are investigating certain types of drugs used to treat arthritis and other conditions.

5 Jun 2008

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

In a national survey released today by the Alliance of Minority Medical Associations (AMMA), Americans noted that their highest health care priority is reducing the cost of prescription drugs. Furthermore, survey respondents shared overwhelming support for creating an approval pathway for generic, or follow-on biotechnology therapies, with 86% of likely voters stating their desire for such a system.

4 Jun 2008

Walgreens to pay $35 million to settle Medicaid prescription drug fraud allegations

Walgreen Co. of Deerfield, Ill., has agreed to pay $35 million to settle claims that from 2001 to 2005, it improperly switched patients to different versions of the prescriptions drugs Ranitidine, Fluoxetine and Eldepryl in order to increase its reimbursement from Medicaid, the Justice Department announced today.

4 Jun 2008

BN ImmunoTherapeutics starts clinical trials with prostate cancer vaccine

BN ImmunoTherapeutics, Inc. has initiated Phase I/II clinical studies with its therapeutic vaccine candidate against prostate cancer.

4 Jun 2008

Settlements between PBMs, States, indicate need for 'stronger medicine' to address problems, Lazarus writes

A $9.5 million settlement with 28 states announced last week by Express Scripts to resolve allegations that the company had "been pocketing money from pharmaceutical companies to steer patients into name-brand drugs" indicates the need for "some stronger medicine" to address problems in the industry, Los Angeles Times columnist David Lazarus writes.

3 Jun 2008