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Viread approved for chronic hepatitis B

The FDA has approved Viread (tenofovir disoproxil fumarate) as a treatment option for adults with chronic hepatitis B, a serious liver disease.

11 Aug 2008

GSK begins shipments of Fluarix and FluLaval to U.S. customers for 2008-2009 flu season

GlaxoSmithKline has announced that it will begin shipment of Flulaval [Influenza Virus Vaccine] and Fluarix [Influenza Virus Vaccine] to U.S. customers for the 2008-2009 influenza season.

11 Aug 2008

NanoViricides reports HIVCide-I significantly superior to current anti-HIV three drug cocktail standard

NanoViricides, Inc. said that additional biological tests and data analysis have shown that animals treated with its lead anti-HIV drug candidate, HIVCide-I, demonstrated a substantially greater reduction in viral load -- number of infectious virus particles per milliliter of blood -- when compared to the animals given the anti-HIV "combo cocktail" in a preliminary animal study. An important objective of anti-HIV treatment is to minimize the viral load.

11 Aug 2008

Boxed warnings now on popuar sleeping pill Stilnox

The popular sleeping pill Stilnox now carries a warning about the potentially dangerous sleep-related behaviours linked to the drug.

11 Aug 2008

Watson Pharmaceuticals announces limited recall of Fentanyl transdermal patches

Watson Pharmaceuticals, Inc. has announced that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies.

10 Aug 2008

FDA warns consumers about Baltimore Medicine Shoppe pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit.

10 Aug 2008

Cancer Research UK expresses 'deep concern' on kidney cancer drug decision

Cancer Research UK - the largest publicly funded research charity in the UK - wants to see the way NICE review the value of drugs altered for rare diseases, such as this type of kidney cancer, where clinical benefit is proven but evidence is limited.

8 Aug 2008

Chlamydia treatment in UK pharmacies will deliver convenient care for patients

Today's decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the reclassification of azithromycin for the treatment of chlamydia infection will mean convenient and effective care for patients, said the Royal Pharmaceutical Society of Great Britain (RPSGB).

5 Aug 2008

FDA approves seasons influenza vaccines

The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

5 Aug 2008

Chlamydia antibiotic available over-the-counter in the UK

For the first time sufferers in the UK from the common sexually transmitted infection (STI) chlamydia will be able to buy an antibiotic to treat the infection over-the-counter (OTC), without a prescription from a doctor.

5 Aug 2008

Lilly reaffirms $3.00 per share purchase offer for SGX Pharmaceuticals

Eli Lilly and Company today reaffirmed that its $3.00 per share purchase offer for SGX Pharmaceutical, Inc. represents its best and final offer for the San Diego-based biotechnology company.

4 Aug 2008

FDA changes policies regarding advisory committees

The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

4 Aug 2008

Abbott Labs agrees to settle lawsuit over antiretroviral Norvir pricing

Abbott Laboratories on Wednesday agreed to pay between $10 million and $27.5 million to settle an antitrust lawsuit filed by HIV/AIDS advocates and other drug companies over an increase in the price of the company's antiretroviral drug Norvir, the AP/International Herald Tribune reports (AP/International Herald Tribune, 7/31).

3 Aug 2008

Fatal flaws in the way new drugs are tested and marketed

Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the way new drugs are tested and marketed, according to research to be presented at the annual meeting of the American Sociological Association (ASA).

3 Aug 2008

Merck announces significant price cuts on two of its AIDS drugs, Stocrin and Isentress

As more than 20,000 people from around the world gather this weekend for the start of the XVII International AIDS Conference in Mexico City, AIDS Healthcare Foundation (AHF) the US-based NGO which provides HIV/AIDS medical care and/or services to more than 79,000 individuals in 20 countries worldwide-including at four free treatment clinics in Mexico-commended Merck & Company (known as Merck, Sharp & Dohme in Mexico) over price cuts on two of its key AIDS drugs in Mexico which were announced yesterday before Sunday's opening of the AIDS conference.

3 Aug 2008

Experimental drug turns lab mice into long-distance runners

Trying to reap the health benefits of exercise? Forget treadmills and spin classes, researchers at the Salk Institute for Biological Studies may have found a way around the sweat and pain. They identified two signaling pathways that are activated in response to exercise and converge to dramatically increase endurance.

31 Jul 2008

A counter to counterfeit drugs

The counterfeiting of medicines has been known of since around 1990 and is a growing problem-in both developing and developed countries. Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach $75 billion by 2010.

30 Jul 2008

FDA seizes more than $24 Million in unapproved new drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

30 Jul 2008

FDA approves first generic divalproex sodium for the treatment of seizures, bipolar disorder and migraine headaches

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

29 Jul 2008

FDA poorly equipped to enforce off-label prescription drug marketing rules, GAO report finds

FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Government Accountability Office, the AP/Minneapolis Star Tribune reports.

29 Jul 2008