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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

U.S. authorities seize Xiadafil VIP tablets after company refuses to recall product

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

24 Jul 2008

New technique measures formation of clumps of proteins in protein-based pharmaceuticals

Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals.

23 Jul 2008

Open access to large-scale drug discovery data

The Wellcome Trust has awarded £4.7 million (€5.8 million) to EMBL's European Bioinformatics Institute (EMBL-EBI) to support the transfer of a large collection of information on the properties and activities of drugs and a large set of drug-like small molecules from publicly listed company Galapagos NV to the public domain.

23 Jul 2008

AstraZeneca Survey: Healthcare professionals leading source of information On company's prescription savings programs

More than a third of the people who contacted AstraZeneca to inquire about the company's prescription savings programs learned of the programs from their doctors or pharmacists, according to a year-long survey of more than 12,000 patients.

23 Jul 2008

Advanced Cancer Therapeutics licenses technology to develop HPV vaccine

Advanced Cancer Therapeutics (ACT) has announced the signing of two new collaborative agreements that will advance development of the Company's novel human papillomavirus (HPV) vaccine program.

23 Jul 2008

Widespread adoption of e-prescribing could save U.S. $156 million over five years

HHS Secretary Mike Leavitt on Monday discussed the details of an electronic prescribing incentive program scheduled to begin on Jan. 1, 2009, that will increase Medicare payments to physicians who adopt the technology, the AP/Chicago Tribune reports.

23 Jul 2008

CMS proposal would limit industry practice that raises costs for some Medicare drug plan beneficiaries

A CMS proposal under consideration would limit a practice used by pharmacy benefit managers known as "lock-in pricing" that can increase costs for beneficiaries enrolled in the Medicare drug benefit and bring them into the so-called "doughnut hole" coverage gap more quickly, the Wall Street Journal reports.

23 Jul 2008

Bioscience fund GBS invests US$6m in Xenome

Biopharmaceutical company Xenome Limited today announced it has received a convertible note placement of US$6 million from GBS Venture Partners, a Melbourne based life sciences specialist that invests in unlisted and listed high growth companies involved in innovative technologies.

23 Jul 2008

Pharmaceutical News

FDA approves seasons influenza vaccines

Chlamydia antibiotic available over-the-counter in the UK

Lilly reaffirms $3.00 per share purchase offer for SGX Pharmaceuticals

FDA changes policies regarding advisory committees

Abbott Labs agrees to settle lawsuit over antiretroviral Norvir pricing

Fatal flaws in the way new drugs are tested and marketed

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

Experimental drug turns lab mice into long-distance runners

A counter to counterfeit drugs

FDA seizes more than $24 Million in unapproved new drugs

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

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

U.S. authorities seize Xiadafil VIP tablets after company refuses to recall product

New technique measures formation of clumps of proteins in protein-based pharmaceuticals

Open access to large-scale drug discovery data

AstraZeneca Survey: Healthcare professionals leading source of information On company's prescription savings programs

Advanced Cancer Therapeutics licenses technology to develop HPV vaccine

Widespread adoption of e-prescribing could save U.S. $156 million over five years

CMS proposal would limit industry practice that raises costs for some Medicare drug plan beneficiaries

Bioscience fund GBS invests US$6m in Xenome

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