Pharmaceutical News

‘Pharmaceuticals giant GlaxoSmithKline posted a 13-percent jump in annual pre-tax profits and said it should start clinical trials within weeks of a vaccine against bird flu.

GSK said 2005 pre-tax profits rose to 6.732 billion pounds (9.805 billion euros, 11.724 billion dollars), while revenue increased 7.0 percent to 21.66 billion pounds from the previous year.’

Read more at GlaxoSmithKline readies bird flu vaccine after annual profits rise

‘Prospects for a new class of effective AIDS medicines soared Wednesday when two drugmakers reported surprisingly strong results from clinical trials of their experimental pills.

The drugs, known as integrase inhibitors, performed in small trials as well or better than most of the antiviral medicines that serve as the mainstays of current therapies, AIDS experts said.’

Read more at 2 promising new AIDS drugs / Strong results in studies

‘Twenty-five people died and 54 more suffered serious cardiovascular problems after taking drugs to treat attention deficit hyperactivity disorder between 1999 and 2003, the government says.

Children accounted for 19 of the deaths and 26 of the cases of non-fatal cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia, according to a Food and Drug Administration report released Wednesday.

The FDA report also includes data on another 26 deaths between 1969 and 2003 in ADHD drug patients. Those include death by suicide, intentional overdose, drowning, heat stroke and from underlying disease.’

Read more at FDA report raises concerns over attention-deficit drugs

‘Lawyers switched legal tactics for the retrial of the first federal Vioxx case, working to convince jurors that manufacturer Merck & Co. ignored safety in favor of sales, rather than opening with medical testimony.

That approach is much closer to an earlier trial in a Texas state court, in which jurors decided Merck should pay $253.4 million, than to the original federal trial. The federal trial ended with a hung jury; jurors reached afterward said the deadlock was 8-1 in Merck’s favor.’

Read more at Lawyers Switch Tactics for Vioxx Retrial

‘Since Jan 1. residents of Nova Scotia have had access to the Diabetic Assistance Program, that gives low-income diabetics who do not have private medical coverage financial help by reimbursing 80 per cent of medication costs. The program was created to ease the burden of diabetes strain on future health costs.

Jim Casey, regional manager of the Nova Scotia Diabetes Association, believes this program is a step in the right direction. Casey says the average cost of treating diabetes is $20 a day. Diabetic supply costs in Nova Scotia are among the highest in the country.’

Read more at Funding program helps diabetics cover costs

‘Vertex stock traded as high as $37.85 in afternoon trading before trimming its gains to close up a little more than 5%.

Before the market’s open, the company said that preliminary Phase II results showed that none of the 12 patients in the trial who used VX-950 in combination with two other leading hepatitis C drugs showed any tangible sign of the virus in their bloodstream after 28 days.

Vertex had tested VX-950 with the drugs pegylated interferon alfa-2a and ribavirin, current standards in treating the life-threatening liver disease. The 28-day study was not designed to measure how long the immune response could be sustained, according to the company.

Vertex plans to unveil full results from the study at medical conference later this year.’

Read more at Vertex Pharma jumps on hepatitis C results

‘The annual Pharmaceutical Marketing and Sales Summit will be held on April 4 and 5 at the Hyatt Regency in New Brunswick. This year’s event is made up of six conferences spotlighting different areas relevant to drug companies.

Between 400 and 600 executives from pharmaceutical and related industries are now expected to attend the event, which is run by the New York City-based Strategic Research Institute.’

Read more at Pharmaceutical Summit Taking Shape

‘An Australian pharmaceutical company is planning to introduce its flu vaccine in the U.S. as early as 2007, becoming the latest manufacturer to pledge increased production a year after a flu shot shortage scared the nation and led to long lines outside clinics.

CSL Limited, based in Melbourne with a subsidiary in King of Prussia, Pa., plans to file for regulatory approval early next year and hopes to offer the vaccines in time for the fall 2007 to spring 2008 flu season. The company is doubling capacity at its Australian plant to 40 million doses a year, half of which should be available for the U.S. market. ‘

Read more at Australian Co. to Enter Flu Vaccine Market

‘Pharmion and MethylGene has announced the formation of an international licensing agreement potentially worth $272 million (€224 million) for new class of compounds that inhibits gene expression providing a tumour and haematological malignancy treatment platform.

The agreement represents a growing band of companies that see epigenetic control of cancer as the way forward treatment-wise. Epigenetics refers to changes in the regulation of gene expression. Epigenetic changes can silence gene expression and, unlike DNA mutations, may be reversed by targeting the enzymes involved.’

Read more at Pharmion and MethylGene in $272 million cancer drug deal

‘The application for an investigational new drug from Northvale-based Elite Pharmaceuticals (Amex: ELI) has been accepted by the U.S. Food and Drug Administration (FDA). Elite submitted the application to the FDA last month.

The drug, a once-daily oxycodone product called OxyQD, takes advantage of Elite’s proprietary sustained-release technology. Oxycodone is the generic version of the narcotic in OxyContin, the popular opioid-based product used to treat moderate and severe chronic pain.’

Read more at Elite Gets Drug Application Approval