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FDA says beware of glycerin imported from China

The Food and Drug Administration (FDA) in the United States has issued a warning to drug manufacturers, suppliers and health professionals that counterfeit drug additives have been using diethyline glycol, or DEG as a substitute for glycerin in cough medicine, fever medication and injectable drugs.

7 May 2007

Doctors say too many Brits addicted to OTC drugs

Doctors in Britain are warning about the dangers of becoming addicted to over-the-counter (OTC) medicines; they say more research is needed on how many misuse OTC drugs.

7 May 2007

Victory Pharma acquires marketing rights for Naprelan

Victory Pharma, Inc. has announced that it has acquired the exclusive US marketing rights to its leading marketed pain product, Naprelan.

4 May 2007

FDA issues "Critical Path Opportunities for Generic Drugs"

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.

4 May 2007

FDA wants new warnings on antidepressant medications

The U.S. Food and Drug Administration (FDA) has proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

4 May 2007

FDA approves new indication for FRAGMIN for the extended treatment of symptomatic venous thromboembolism

The U.S. Food and Drug Administration (FDA) has approved a new indication for FRAGMIN (dalteparin sodium injection), for the extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in patients with cancer.

4 May 2007

AIDS Healthcare Foundation praises Thailand for drug stance

AIDS Healthcare Foundation (AHF) has lauded the Government of Thailand for its vow to continue with plans to issue compulsory licenses for the manufacturing and importing of generic versions of lifesaving drugs, including AIDS drugs, despite the fact that the office of United States Trade Representative (USTR), elevated Thailand to its 'Priority Watch' List.

4 May 2007

FDA - all antidepressants need new warning labels

The Food and Drug Administration (FDA) in the United States wants the manufacturers of antidepressant medications to change the labels on their products.

3 May 2007

Some physicians not purchasing, restricting recipients of Gardasil because of cost, Washington Post reports

Inadequate reimbursement from insurance companies for Merck's human papillomavirus vaccine Gardasil is leading some physicians to refuse to purchase the vaccine and restricting the recipients to those whose insurers have agreed to pay a "reasonable" fee, the Washington Post reports (Boodman, Washington Post , 5/1).

2 May 2007

U.S. trade rep places Thailand on priority watch list in annual report

The Office of the U.S. Trade Representative in its annual report released on Monday placed Thailand on its Priority Watch List in part because the country recently issued compulsory licenses for several medicines, including two antiretroviral drugs, CongressDaily reports.

2 May 2007

Some doctors refuse to purchase cervical cancer vaccine because of low reimbursements

Some physicians are refusing to purchase Merck's cervical cancer vaccine Gardasil or are restricting who receives it because they say insurance reimbursements for the vaccine are too low, the Washington Post reports.

2 May 2007

Senate begins debate on prescription drug user fee act reauthorization bill

The Senate on Monday began debate on a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, with senators expected to propose a number of amendments to the legislation, the AP/Dallas Morning News reports ( AP/Dallas Morning News , 4/30).

2 May 2007

Consumers have broad access to pharmacy choices

Consumers have broad access to pharmacy choices in urban, suburban, and rural areas, as an average of 21 pharmacies are located and compete near independent pharmacies throughout the United States, according to an analysis conducted by SK&A Information Services and released by the Pharmaceutical Care Management Association (PCMA).

2 May 2007

Eli Lilly to publish grant and contribution information

Eli Lilly and Company has announced that it will begin posting online all educational grant funding and other monetary contributions provided to U.S.-based organizations.

2 May 2007

Generic biologic drugs unlikely to be cheaper than brand-name drugs

Generic versions of a class of medicines called "biologics" would not be significantly cheaper than brand-name versions of the medicines, according to research from professors at Duke University's Fuqua School of Business.

2 May 2007

FDA advisory committee supports Advair 500/50 in reducing COPD exacerbations

An Advisory Committee to the Food and Drug Administration (FDA) has unanimously agreed that GlaxoSmithKline's Advair Diskus 500/50 (fluticasone propionate and salmeterol inhalation powder) demonstrated a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S.

2 May 2007

New human medications found in fish in Texas

Baylor University researchers have found the residue of three new human medications in fish living in the Pecan Creek in North Texas.

2 May 2007

Cancer Research Technology licenses therapeutic antibodies to Peptech

Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, today announces it has licensed rights to a panel of cancer therapeutic antibodies to Peptech Limited.

2 May 2007

CBO report examines proposed changes to prescription drug user fee act

Cost Estimate: S 1082, Prescription Drug User Fee Amendments of 2007," Congressional Budget Office: The CBO report details proposed changes to the Prescription Drug User Fee Act and outlines spending and costs to federal and state governments.

1 May 2007

Lawmakers have proposed 'witch's brew' of biotech bills

Lawmakers in recent months "have stirred up a witch's brew of initiatives that is cause for some concern -- not only for the biotech industry, but for all Americans," James Mullen, president and CEO of Biogen and chair of the Biotechnology Industry Organization, writes in a Wall Street Journal opinion piece.

1 May 2007