Tamiflu

ALSO NOTED: Endo buys Novartis' Voltaren; Microbia, Forest produce positive Phase III data; and much more...

Wed, 05 Mar 2008 06:59:50 -0500

> Endo Pharmaceutical is buying Novartis' Voltaren gel for $85 million upfront and a one-time sales milestone of $25 million. Release

> Researchers for Microbia and Forest Laboratories have produced positive Phase II data from two studies of linaclotide in patients with chronic constipation as well as patients with irritable bowel syndrome with constipation. Release

> MorphoSys has inked a deal to supply genetically engineered antibodies to Spain's Proteomika SL for use in research into diagnostics and novel treatments. Release

> After some arm-twisting from the FDA, Roche has added stronger warnings to its Tamiflu label. Report

> A new study shows that costlier drugs may work better. Report

> Another prominent South Korean biomedical researcher stands accused of faking data that appeared in prestigious scientific journals. Report

> Leaders in the nanotech field have been beating a path to Congress, asking lawmakers to significantly boost federal support of research into molecular-level advances. Report

> Hormones produced by the heart could play a remarkable role in controlling and perhaps even curing cancer. Report

> Forget those studies of long-lived Italian shepherds and Greek fishermen. It's not fresh air or exercise or a simple whole-foods diet that causes certain people to live past 100, a new study shows. Instead, it's a set of genetic mutations thought to interfere with normal cell growth and thus slow aging. Report

And Finally... Several of the world's top biomedical research institutes--including a couple run by biopharma giants--have made this year's list of the best places for postdocs to work. Report

ALSO NOTED: BMS hands back drug rights; OncoMethylome in deal with GSK; Celgene shares take a bounce; and much more...

Mon, 26 Nov 2007 06:59:50 -0500

> Bristol-Myers Squibb has returned the rights to vinflunine to Pierre Fabre. The therapy was studied as a treatment for bladder cancer. Release

> Belgium's OncoMethylome Sciences has forged a pact with GlaxoSmithKline to develop DNA methylation biomarkers for use in developing personalized cancer therapies. Release

> Shares of Celgene got a bounce this morning after a Banc of America analyst give a thumb's up to the company's expanded line-up of cancer therapies with its acquisition of Pharmion. Katherine Kim concludes that Revlimid can earn $3.5 billion a year. Report

> Sanofi Pasteur says it's spending about $104 million on a Chinese manufacturing plant in hopes of launching flu shots locally by 2012. Report

> A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. Report

> The FDA also plans to review Roche's Tamiflu and GlaxoSmithKline's Relenza at its advisory committee confab Nov. 27-28. At issue: the anti-influenza drugs' potential neurological side effects in kids. Report

The FDA is taking a second look at the safety of three asthma drugs used in kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil. Report

> QRxPharma has begun treating patients as part of the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. Release

> An M.D. and former speaker-on-behalf-of-a-drug tells his story in the New York Times Magazine, and it's an illuminating, behind-the-scenes look at how Dr. Daniel Carlat (photo) became Dr. Drug Rep.

And Finally… In a major study, transcranial magnetic stimulation proved effective in treating major depression. Report

ALSO NOTED: NPS sells facility; NICE backs Tysabri; Xolair gets black box warning;and much more...

Tue, 03 Jul 2007 00:01:30 -0400

> As part of its restructuring, NPS Pharmaceuticals has sold its Salt Lake City facility to the University of Utah for $21 million. Report

> The National Institute for Health and Clinical Excellence in England has endorsed Tysabri for MS patients. Release

> The FDA has added a black box warning to Genentech's Xolair for asthma. Report

> Novartis says it will increase its U.S. supply of Fluvirin flu vaccine by 30 percent to 40 percent. Report

> The FDA has approved Tamiflu in 30 mg and 45 mg. Report

> Patients with inoperable non-small cell lung cancer who receive an initial high dose of chemotherapy before their treatment begins can expect an increase in overall survival, according to a new study. Release

> In a remarkable breakthrough for weight research, scientists have reported the discovery of a neurochemical pathway that stimulates the accumulation of fat in animals laboring under chronically high stress and exposed to a diet of junk food. Report

> The heart drug propranolol can be used to interfere with the way the brain stores memories, offering a new approach to treating people with post traumatic stress disorder. Report

And Finally... The first half of 2007 has been tough for biotech stocks. Report

CDC offers advice in combating a pandemic

Thu, 01 Feb 2007 19:01:35 -0500

With experimental vaccines in short supply, the CDC has outlined a series of public responses to a flu pandemic. Saying the U.S. needs to prepare for a "Category 5" pandemic, the agency suggests that schools should be closed and public events should be canceled to help slow the spread of a dangerous outbreak. In addition, the CDC is suggesting that business shifts should be staggered and entire families should stay home if one of them is sick. But the CDC is warning against closing state borders or disrupting transportation, noting that such a strategy would interrupt the flow of emergency supplies. The U.S. government, like many around the world, has been stockpiling Tamiflu, although resistant strains of H5N1 have already emerged.

- check out the CDC's plans
- here's the article on pandemic preparations

PLUS: HHS has triggered a provision giving vaccine makers immunity from product liability suits. The agency called it a precautionary step in light of new cases of avian flu in Asia and Nigeria. Report (WSJ sub. req.)

Related Articles:
New CDC guidelines target drug-resistant infections. Report
HHS issues contracts for pandemic vaccine research. Report
WHO recommends dual therapy for avian flu. Report

SPOTLIGHT: New bird flu strain emerges

Wed, 17 Jan 2007 19:01:33 -0500

The World Health Organization says that two Egyptians were infected by a new strain of bird flu that is resistant to Tamiflu. They don't know how the strain developed, but noted that it is worrying as Tamiflu remains the primary protection against the H5N1 version of avian flu. Report

ALSO NOTED: EU committee recommends Parkinson's therapy; Actavis to close warehouse; and much more...

Thu, 16 Nov 2006 19:01:30 -0500

> The European Committee for Medical Products for Human Use has recommended that Schwarz Pharma's Neupro patch be approved for use against Parkinson's. Report

> The CHMP has recommended Novartis AG's Exforge hypertension drug and Lucentis treatment for blindness. Report

> The Committee for Medicinal Products for Human Use also concluded that Tamiflu does not pose a health risk. Report

> Actavis Group is closing a warehouse in Maryland. Report

And Finally...The CDC has significantly revamped the way it cares for lab animals. Article

ALSO NOTED: Dr. Reddy's raising $260M; Alexion wins priority review; new data supports orencia; and much more...

Mon, 13 Nov 2006 19:01:30 -0500

> The generic drug maker Dr. Reddy's Laboratories plans to raise $260 million through an issue of 13.5 million American Depositary Shares. The Indian company has been on an acquisition spree, acquiring Germany's Betapharm in March as it pursued a strategy of expanding in the European market. Report

> The FDA has agreed to provide a priority review of Alexion Pharmaceuticals' anemia drug eculizumab. Report

> Bristol-Myers Squibb is touting new data that shows orencia helped improve a form of arthritis in children. Report

> Regeneron Pharmaceuticals, which is researching new therapies for cancer and eye and inflammatory diseases, plans to offer 7.6 million common shares. Release

> Roche's Tamiflu will carry new warnings about delirium. Report

> Cancer diagnostic company Zila has signed agreements for a $40 million private placement. Release

> DeCODE genetics is proposing to make an offering of 3.5% senior convertible notes due 2011. Release

> Spectrum Pharmaceuticals announced that it has settled a patent dispute with Glaxo over a generic version of Imitrex injection. Report

> Huifeng Bio-Pharmaceutical announced today that it has agreed to purchase two production lines of a Chinese corporation in exchange for 2 million newly issued shares of Huifeng restricted stock. Release

And Finally… Researchers in Sweden provided free junk food to students to test the effects of a high-fat diet. They gained weight, but their bodies swiftly adjusted to the change. Article

Roche's Tamiflu ads spark criticism

Maureen Martino — Wed, 01 Nov 2006 12:55:12 -0500

If Roche has its way, a gaggle of happy penguins will charm consumers into stocking up on flu drug Tamiflu. Using penguin characters from a current children's feature as a theme, Roche Pharmaceuticals has developed a multi-million dollar ad campaign to create demand for the costly medication. Tamiflu, which has attracted international attention as a possible stopgap in the war against bird flu, is designed to slow flu progression and minimize symptoms. The ads, which come just before the start of flu season, don't mention Tamiflu specifically. Critics say the promotion is irresponsible. Dr. Jerry Avorn, a Harvard Medical School professor, argues that the drug's benefits are minimal. Worse, he suggests that if consumers use Tamiflu heavily, Americans will develop a resistance to the drug and won't benefit from it if and when bird flu does become a pandemic. The drug is already proving to be a bonanza for Roche. The pharmaco reported that Tamiflu sales rose to $1.3 billion during the third quarter of this year, an increase of 88 percent over the Q3 '05. Report

ALSO NOTED: India funds training centers; Memory gains milestone;and much more...

Tue, 31 Oct 2006 19:01:30 -0500

> India is funding clinical research training centers around the country to help spur the country's involvement in drug research. Report

> Memory Pharmaceuticals has received a $2 million milestone for MEM 3454. Release

> VWR International has established a wholly owned subsidiary in Bangalore, India. Release

> EntreMed has begun a Phase II trial of Panzem for ovarian cancer. Release

> Regulators have approved Watson Pharmaceuticals' acquisition of Andrx. Report

> Researchers have grow a miniature liver from stem cells. Report

> Roche's Tamiflu ad campaign featuring penguins (picture) has sparked criticism. Report

And Finally... A new study that concludes a brain abnormality could be behind sudden infant death syndrome points may help researchers develop a new therapy. Article

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

Novartis wins $220M flu vaccine contract

Wed, 03 May 2006 20:01:37 -0400

Novartis has won a $220 million contract to supply cell culture-derived flu vaccine to the Department of Health and Human Services. The deal will help support seasonal flu programs as well as preparation efforts for a possible bird flu pandemic and the biopharma giant announced plans to create a new manufacturing site in the country using a biotech process to make vaccines. "We will be investing additional resources in highly skilled researchers to set up one of the first flu cell culture manufacturing sites in the US. This plant will contribute to America's vaccine infrastructure for seasonal flu and support the US government's ability to respond quickly to a potential pandemic, with access to new technologies to ensure sufficient capacity," said Novartis CEO Dr. Daniel Vasella.

- read the release on the contract

PLUS: A new study indicates the ideal dosage of Tamiflu for fighting bird flu. Article

ALSO: Noted virologist Robert Webster says that cultural prohibitions on autopsies in Asian countries are hampering scientific efforts to understand bird flu. Report

Gilead banking $1.3B for new deals

Wed, 26 Apr 2006 20:01:36 -0400

Analysts are bullish on Gilead Sciences, which recently sold $1.3 billion in debentures to fund new licensing deals and acquisitions. Gilead, which is receiving a substantial revenue stream from Roche for Tamiflu, has a deal to buy the remaining shares of Corus Pharma following Phase III data.

- read the Forbes report for more information

PLUS: Bristol-Myers Squibb and Gilead have filed for approval of a once-daily HIV treatment that combines Sustiva and Truvada. Report

U.S. unprepared to stop flu pandemic

Wed, 26 Apr 2006 20:01:35 -0400

A new report out in Nature concludes that the U.S. is no position to slow down the spread of a flu pandemic that is likely to afflict one third of the population if it hits. And if the government quickly stockpiles antivirals, it can still only cut that figure to 28 percent. The bottom line: There is no silver bullet to protect people from a pandemic, according to the computer modeling done by the Department of Infectious Disease Epidemiology at Imperial College in London. Tamiflu and school closings may help slow the spread of a pandemic, say the researchers. But efforts to stop the spread of a pandemic into the U.S. is likely to only delay its arrival by a couple of weeks. The U.S. has enough medicine on hand to treat about 1.7 percent of the population, far below the 25 percent needed to blunt the impact of the disease.

- here's the CNN 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

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: Chiron pulls MMR vaccine off the market; Targacept sets IPO price; and much more...

Wed, 15 Mar 2006 19:00:50 -0500

> Chiron is pulling Morupar, its vaccine for measles, mumps and rubella, off of the market after determining that it was linked to a higher rate of adverse effects than other vaccines. Chiron revised its projected earnings for 2005 down three cents a share as a result. Adverse reactions include fever, swelling of the glands and allergic responses. Sales of Morupar were $10 million last year, a tiny fraction of the company's overall revenue. Report

> Targacept set its planned IPO at 5 million shares at $11 to $13 a share. Report

> Roche says that its capacity to produce Tamiflu now exceeds government orders for the drug, which is seen as a possible protection against bird flu. Report

> Researchers say that a new type of immune cell found in the lungs of asthma patients offers a new target for drug makers looking for more effective therapies. Report

> The FDA wants stronger warnings on the risk of side effects posed by ADHD drugs. Report

> South San Francisco-based Titan Pharmaceuticals says it will raise $10 million in a stock offering. Release

> Chutes & Ladders: La Jolla Pharmaceuticals has named Deirdre Y. Gillespie, M.D. as its new CEO in the wake of the resignation of Steven Engle. Report

> Conor Medsystems has licensed pimecrolimus from Novartis Pharma for use with Conor's vascular drug delivery technologies. Release

> Metabasis Therapeutics reviewed Phase II results for the oral antiviral pradefovir. Report

And Finally… A new study found that seniors benefit more from antidepressants than psychotherapy when recovering from depression. Article

ALSO NOTED: Takeda licenses Hematide; Lectus garners £8.2M; YM shares gain on fast-track announcement;and much more...

Sun, 12 Feb 2006 19:00:50 -0500

> Takeda Pharmaceuticals has agreed to pay $27 million in an upfront payment and direct investment and up to $75 million in milestone payments in exchange for the commercial rights to Affymax's anemia therapy Hematide in Japan. Report

> The UK's Lectus Therapeutics has rounded up £8.2 million in its first round of venture capital. Report

> Shares of YM Biosciences rose on the news that the FDA had put its lead breast cancer therapy on its regulatory fast track review program. Report

> A leading dermatology group says the FDA program to steer pregnant women from the acne drug Accutane is a "disaster." Article

> Chugai Pharmaceuticals, a subsidiary of Roche, is preparing to ramp up production of Tamiflu for the Japanese market. Report

> American Pharmaceutical Partners has received FDA approval for a generic version of Novartis' Sandostatin. Report

> BioXell and Lay Line Genomics have inked a licensing deal for the development of MNAC13, a humanized monoclonal antibody that binds to TrkA receptors, blocking the action of Nerve Growth Factor, a key mediator of pain. Release

> Myogen announced positive top line results of the AMB-222 study, an open-label study of ambrisentan in patients with pulmonary arterial hypertension. Release

> Biovitrum and Amgen have expanded their licensing deal to develop Biovitrum's small molecule 11beta-HSD1 enzyme inhibitors for the treatment of metabolic diseases. Release

And Finally… A host of Canadian pharmacies report a sharp spike in the number of seizures of drug shipments to patients south of the border. Article

Sanofi sells out of Tamiflu in one day

Sun, 05 Feb 2006 19:01:38 -0500

It took less than a day for Sanofi Pasteur to sell the 50 million doses of Tamiflu it plans to make for the 2006-2007 flu season. Sanofi has been inundated with orders for Tamiflu, which may help fight the deadly H5N1 virus that has killed dozens of people in Turkey and Asia. Fears have grown that the virus, which spreads from birds to people, may mutate into a disease that can spread from person to person.

- read this report from the Pocono Record

PLUS: The U.S. government has ordered an extra $50 million of experimental bird flu vaccine from Sanofi-Aventis to stockpile against a potential flu pandemic. That's on top of the $100 million order made by the U.S. in September. Report

ALSO: Local health authorities say that very little real planning is underway in the U.S. for a pandemic and few new funds are being made available to change that anytime soon. Article

Roche reports profit surge, drug delay

Tue, 31 Jan 2006 19:01:37 -0500

With demand for Tamiflu soaring, Roche reported pre-tax profits surged 36 percent in 2005, hitting $7 billion. That was well ahead of market expectations. The bulk of Roche's growth was concentrated in its pharmaceutical division. Perhaps the biggest news from Roche today, though, was that it would delay filing for approval for its anti-anemia drug CERA until 2009. Some analysts had been expecting it to head for the FDA as early as 2007. That news helped buoy Amgen, which markets a rival anti-anemia therapy.

- read this Financial Times report for more on its profits
- see this report on CERA

EU approves Tamiflu for children

Mon, 30 Jan 2006 19:01:38 -0500

The European Union has approved the use of Tamiflu to prevent flu in children. The antiviral drug was cleared by the FDA for children in December. The twin approvals are aimed at giving doctors another weapon to stop the spread of influenza. Children are much more likely than seniors to contract and die from the flu. Governments around the world have also been stockpiling Tamiflu in the hope that it would help protect people in the event of a worldwide bird flu pandemic.

- read this report from the Financial Times

ALSO: A 15-year-old Iraqi girl has died of avian flu, marking the spread of the virus to another country. Report