virus

SPOTLIGHT: Rotarix gets FDA committee nod

Thu, 21 Feb 2008 06:59:53 -0500

An FDA advisory panel agreed Wednesday that GlaxoSmithKline's Rotarix vaccine was safe and effective, recommending the anti-rotavirus shot for agency approval. Rotarix is designed to help protect infants from gastrointestinal illness caused by that virus. The FDA is set to say yea or nay by April 3. If approved for sale, Rotarix will compete with Merck's RotaTeq, which has been on the market since 2006. Report

In surprise move, Crucell dumps West Nile program

Tue, 12 Feb 2008 06:59:56 -0500

The Dutch developer Crucell has opted to shelve its development program for a West Nile vaccine after seeing a drop in the number of people infected by the virus in the U.S. That was a surprise move to analysts, who had considered the vaccine program one of the key therapies in Crucell's pipeline. But Crucell Chief Executive Ronald Brus says it just doesn't make sense to proceed. Some 10,000 Americans were infected by West Nile in 2003 when it launched the program. Last year that figure dropped to 3,000. Crucell's shares slid four percent on the news.

- see this excerpt from Crucell's earnings report
- read the report from The Guardian

Related Articles:
Crucell, MedImmune strike deal. Report
Crucell acquires SBL Vaccin for €39.4M. Report
Crucell halts Aerugen development. Report

Long delay seen for Merck's AIDS vaccine

Wed, 14 Nov 2007 06:59:57 -0500

The fallout over Merck's disastrous AIDS vaccine trial continues. There are new reports out that other developers have put their trials on hold while researchers and the FDA ponder the safety issues posed by Merck's program, which may have exposed trial participants to a heightened risk of contracting the virus. Merck is now going back to the trial participants to let them know about the extra danger they face.

"The recent Merck trial results were a big blow to the field," Dr. Gary Nabel, director of the National Institutes of Health's Vaccine Research Center in Bethesda, told the Baltimore Sun. Some now estimate that any new vaccine to protect people from AIDS is at least a decade away. But work in the field is continuing.

- see this report from The Baltimore Sun
- read the report on the trial participants

Relate Articles:
Merck's HIV vaccine linked to higher infections rate. Report
Merck halts study of "ineffective" HIV vaccine. Report
New advances made in gene therapy for HIV. Report
AIDS scientist backed on new vaccine approach. Report

Investors disappointed in Vertex despite strong data

Mon, 05 Nov 2007 06:59:57 -0500

Vertex shares sank on Friday after the company reported that its closely-watched hepatitis C drug telaprevir eradicated the virus in more than 60 percent of patients. Standard therapies on the market have a success rate of 50 percent or less, making telaprevir a clear favorite. But Vertex has been the subject of considerable speculation, with some analysts looking for efficacy rates of around 70 percent for the hepatitis C drug. With plenty of competition in the field, investors took a look at what most biotechs would consider a clear winner and sent shares down about nine percent.

The money men on Wall Street appeared to be particularly concerned by dropout rates of 18 percent and 12 percent in the Phase IIb studies and a lack of data from the control arm, which dosed patients with a combination of pegylated-interferon and the antiviral drug ribavirin.

- see this release
- check out the AP report on telaprevir

Related Articles:
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report
Vertex refines terms on $300M public offering. Report
Vertex gets good news for RA drug. Report

New investigation underscores distrust of China

Mon, 20 Aug 2007 06:59:54 -0400

A group of experts has flown to China to investigate a recent outbreak of a virus afflicting the country's pigs. That move underscores the lingering concerns that China is still failing to be open about the diseases that start there and have the potential to spread around the world.

- read the The Wall Street Journal article (sub. req.)

Related Articles:
China pushes drug development as R&D soars. Report
China drug czar executed for corruption. Report
China to overhaul drug safety regulations. Report
Bridge Pharma sees growth in China drug studies. Report

SPOTLIGHT: Wyeth in licensing deal

Mon, 09 Jul 2007 00:01:33 -0400

Wyeth could gain up to $5 million through next year in a licensing deal with Novavax covering its virus-like particle technology for use in vaccine development. The technology creates viruses that mimic the disease-causing virus but lacks genetic material needed to make it a threat. Release

VIRxSYS gains $20M in financing

Tue, 12 Dec 2006 19:01:34 -0500

Weeks after it released positive data on an early-stage study of its experimental gene therapy for HIV, VIRxSYS has raised $20 million in a series G round of financing. Some of that money will be used to support a Phase II trial of VRX496 for HIV. VRX496 relies on an HIV-based lentiviral vector--or viral container--from which the disease-causing aspects of the virus have been removed, leaving behind an efficient gene-delivery vehicle. VIRxSYS then equips the vector with a long antisense sequence against the HIV envelope protein to create VRX496.

- check out the release on the new round

Sanofi vaccine effective against new bird flu strains

Wed, 18 Oct 2006 20:01:36 -0400

Sanofi Pasteur says that its experimental bird flu vaccine has proved effective against recent variations of the virus, leading its researchers believe that the therapy could be effective against a viral mutation that could trigger a human pandemic. Sanofi researchers announced last May that the vaccine appeared safe and effective in early human trials. And the new data indicates that the vaccine produces antibodies that work against recently discovered strains of H5N1.

- here's the AFX report on the vaccine

Ambrilia inks $232M licensing deal of HIV drug

Wed, 11 Oct 2006 20:01:38 -0400

Canada's Ambrilia Pharmaceuticals has licensed its early-stage lead product to Merck for $17 million up front and up to $215 million in milestones. The first milestone of $3 million will be rewarded for a successful completion of its ongoing Phase I dosing study of its HIV drug PPL-100. Data from that study is expected in November. After that study is wrapped, Merck is responsible for development costs.

Researchers at Ambrilia have touted PPL-100 for its ability to bind to the protease enzyme, keeping it effective after several mutations of the virus. And the company believes that the therapy can also act to enhance existing inhibitors in a drug cocktail.

- here's the report on Ambrilia's deal from The Globe and Mail

Indonesia identifies new clusters of avian flu cases

Wed, 02 Aug 2006 20:01:37 -0400

Indonesia is investigating what could be two new clusters of bird flu victims, including one that is in the same area where seven family members were recently wiped out in one of the most alarming clusters seen yet. Researchers began to look for human victims of the disease when they discovered several dead birds in the area. The virus has not been confirmed in the new clusters, but Indonesian health officials are treating it as H5N1 pending lab confirmation.

- see this article on Indonesia from The Wall Street Journal (sub. req.)

ALSO: A new outbreak of bird flu in Thailand is fueling fears in that part of the world as well. Article

Scientists confirm human-to-human H5N1 case

Thu, 22 Jun 2006 20:01:36 -0400

Scientists have confirmed the first case of human-to-human transfer of bird flu involving a father and son in Indonesia. The researchers concluded that the virus had slightly mutated, allowing for the confirmation in how the virus spread. But researchers emphasized that the virus had not mutated in a way that would make it easier to spark a pandemic.

- here's the article from the New York Times on the case

WHO recommends dual therapy for avian flu

Sun, 21 May 2006 20:01:37 -0400

The World Health Organization has suggested a dual-therapy approach to certain cases of avian flu that combines Tamiflu with one of the older antiviral drugs on the market: amantadine and rimantadin. Researchers say that the dual therapy could prevent the virus from replicating.

- here's the AP report for more on the dual therapy

ALSO: The director general of the World Health Organization, Dr. Lee Jong Wook, died this morning after emergency surgery for a blood clot. Report

U.S. to buy 95 million flu drug doses

Tue, 02 May 2006 20:01:38 -0400

The federal government plans to stockpile 75 million doses of antiviral drugs and 20 million doses of an experimental vaccine to help combat a potential bird flu pandemic. The plan is expected to be released later today, but The New York Times was briefed on the essential outlines of the government's response. In addition, the government has outlined plans to have police and the National Guard maintain public order, with help from the military as needed. And businesses are being encouraged to develop plans that would factor a 40 percent absenteeism rate during successive waves of bird flu outbreaks.

- here's the New York Times report on the plan

ALSO: Shares of Vical, meanwhile, soared 31 percent after the drug developer announced promising results from an animal study of its experimental bird flu vaccine. The vaccine completely protected mice and ferrets exposed to the virus. Investors were particularly enthused by signs that the vaccine could work against multiple strains of the virus. Any human pandemic requires a viral mutation that can significantly alter the way it works, and change its response to more narrowly targeted therapeutics. Report

Roche stockpiles Tamiflu for bird flu

Tue, 18 Apr 2006 20:01:35 -0400

Roche says that it has assembled a stockpile of 30 million capsules--three million treatment courses--of Tamiflu that is ready for the World Health Organization on request. Roche can deliver the drugs on demand to any international airport that is requested by WHO. The drugs are intended to slow the spread of a potential pandemic. Roche has been rapidly scaling up its production capability of Tamiflu, saying it can now produce up to 400 million treatment courses a year.

- read the MarketWatch report on the stockpile

ALSO: Indonesian health officials have confirmed the country's 24th death from bird flu while Sudan has announced that the virus has been confirmed in poultry and one man. Report

Biotechs benefit as fear of bird flu spreads

Wed, 22 Mar 2006 19:01:37 -0500

If you were wondering exactly what a bird flu program could do to a biotech's stock, check out this report from USA Today. It includes a list of drug developers that could play a role in fighting bird flu and their stock fluctuations so far this year. They include BioCryst (up 14.4 percent), Carrington Labs (up 44 percent), Alnylam (up 29 percent) and Novavax (up 95 percent). Analysts have been putting together various bird flu strategies for investors that includes weighting investments toward drug companies and away from the kind of travel outfits likely to get hammered if, and this is a big if, a human pandemic breaks out. Call it the globalization of the fear factor. Any outbreak of a human-to-human avian flu will likely trigger an economic tsunami that can be far more devastating than anything terrorists could dream up. For the record: Just about every prominent virologist will only say that a pandemic is a possibility.

- read the article from USA Today

PLUS: Any human pandemic, of course, is predicated on a genetic mutation of the virus. New research indicates that right now the virus doesn't easily connect to cells in the nose, throat and upper respiratory tract. The virus needs to get deep into the lungs to infect someone, which is why close exposure to infected birds has been the key characteristic of the people who have been affected so far. Common human flu viruses can swiftly attach themselves to more easily accessible cells. A mutation, of course, could change all of that. Article

Scientists study mutations leading to flu pandemics

Thu, 16 Mar 2006 19:01:35 -0500

Scientists at the Scripps Research Institute in La Jolla have been studying the genetic mutations that have allowed viruses to spark human pandemics. By comparing H5N1 to earlier bird flu varieties, the scientists have been able to compare mutations to see how the virus attaches itself to human cells. H5N1 relies on the protein hemagglutinin to transfer genetic information into cells, which are then rapidly copied as the infection develops. For now, the virus doesn't attach itself to the sugars that coat cells in airway tracts. By studying various mutations, the scientists hope to determine which mutations will accomplish that task, threatening a human pandemic.

- read the article from the San Diego Union-Tribune

PLUS: Hemispherx Biopharma says new research shows that its immune system booster Ampligen can increase the effectiveness of Tamiflu by a factor of 100. Only one to two percent of the amount of Tamiflu needed to treat avian flu on its own was needed when combined with Ampligen. Report

ALSO: Add Israel to the list of countries that have confirmed finding the virus in poultry. Report

ALSO NOTED: Advanced Life Sciences raises $36M; bird flu spreads; groups demands Darvocet removal; and much more...

Mon, 27 Feb 2006 19:00:50 -0500

> Canada's QLT says it will fight an injunction blocking the sales of its pancreatic cancer therapy Eligard. A federal court in Illinois granted the injunction against the sale or marketing of Eligard until May 1. The injunction was sought by TAP Pharmaceuticals, which claims that QLT and Sanofi-Aventis violated their patent. The court, which stayed its ruling for seven days, also ordered a voluntary recall of the therapy. Report

> Advanced Life Sciences of Woodridge, IL has raised $36 million through a private placement of stock. Release

> With officials testing for bird flu in Ethiopia and Kenya and fresh signs of the virus cropping up in domestic poultry in Europe, UK officials have begun preparing for what they see as the inevitable arrival of the virus in their country. Scientists believe that once it does arrive in the UK, the virus will become endemic, staying for five years or more. The situation in Europe is already equivalent to "living under machine gun fire." Article

> Public Citizen is demanding the removal of the painkiller Darvocet from the market, claiming it is addictive, is no safer than alternatives and has been linked to more than 2,000 accidental deaths. Release

> Germany's Artemis Pharmaceuticals has agreed to create genetically engineered murine models for Bristol-Myers Squibb's drug discovery work. Release

> Business Objects and IBM have partnered up to offer a better way to identify potential candidates for research studies as well as predicting "at risk" patients based on their similarity to a patient cluster--ultimately improving the effectiveness of diagnosis and treatment. Release

> Biogen Idec has been ordered to turn over MRIs of a woman who died after taking Tysabri. The widower of Anita Smith sued Biogen Idec, saying that she did not have multiple sclerosis when she signed on to a trial of Tysabri in combination with Avonex. Report

> Australian scientists have published research on removing cells that are potentially cancerous. Report

> A judge has set a June 6 court date for the first trial involving Celebrex. Report

> Pfizer has shuffled management duties at its US pharmaceuticals division. Report

> Antares Pharma plans to raise $11 million through a private placement. Report

> King Pharmaceuticals has reached agreement on a patent dispute with Sanofi-Aventis Deutschland and Cobalt Pharmaceuticals. Report

And Finally… Heart disease is harder to detect in women, which makes it consequently more deadly. Article

SPOTLIGHT: Preparing for a pandemic

Sun, 12 Feb 2006 19:01:33 -0500

In an editorial, The Washington Post says that the appearance of avian flu to Africa demonstrates that the spread of the virus is out of control. Despite high-level attention, the newspaper calls on the U.S. and other countries to better coordinate their avian flu response with a heavy focus on research into a new vaccine. The editorial calls for a timeline, leadership and major incentives to accelerate research in the face of a possible human pandemic. Report

Azerbaijan reports bird flu infections

Thu, 09 Feb 2006 19:01:35 -0500

Add Azerbaijan to the list of countries that are now fighting the spread of avian flu. Infected birds have now been found along its Caspian Sea coast. Meanwhile, another bird flu victim in Indonesia died and there are new reports that Nigerian health officials have done little to stem the spread of the virus since it was discovered in the West African nation. Virologists have been closely following the spread of the virus as it travels swiftly around the globe on the wings of migratory birds. They're afraid that it will eventually infect someone who has a human version of the flu and cause it to mutate into a disease that can pass from human to human. Sub-Saharan Africa has a poor healthcare system and few veterinarians needed to handle a response to bird flu.

- read this report for more information

Vertex shares jump on hep C trial data

Tue, 07 Feb 2006 19:01:36 -0500

Shares of Vertex surged on Tuesday after the drug developer reported positive results for its Phase II trial of VX-950, its hepatitis C drug candidate. After 28 days of treatment, none of the 12 patients taking VX-950 in combination with two other standard therapies had signs of the virus in their blood. Vertex CEO Joshua Boger called the data "surprisingly good." Final results will be released later in the year.

- read this MarketWatch report