Thursday, November 13, 2008

FDA Warns Public of Extortion Scam by FDA Impersonators

and you thought all you had to worry about was e-mails from dethroned Nigerian princes...

FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

link to full article

Thursday, October 30, 2008

Phillies win!! Economy doomed?

It's worth it...every 25 years or so...and this post has all the charts and graphs to prove it...

link to Drug Channels post regarding economic impacts of the Phils winning the Fall Classic

Wednesday, October 29, 2008

Only 59% of Pharma Companies...

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

link to full article

link to report download

Tuesday, October 28, 2008

Diabetes drug costs soaring, top $12B last year

I think they've found the new blockbuster...

Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion.

Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin — an inexpensive generic used reliably for decades — may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said Dr. David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

link to full article

Thursday, October 23, 2008

China arrests 6 for role in contaminating milk

How many points in this story make no sense?...the over-under is 4...

BEIJING – China arrested three people Thursday for allegedly adding a toxic chemical to fresh milk to mask the fact that it was watered down and three others for selling the chemical.

The practice of adding melamine, a nitrogen-rich substance used in making plastics and fertilizers, to milk supplies is blamed for killing four babies in China and sickening tens of thousands.

The babies were sickened by powdered infant formula that authorities believe was made from tainted fresh milk. Melamine has also been found in other Chinese dairy products, including yogurt, candy and cream cookies.

More than 3,654 Chinese children remain hospitalized for kidney stones or other symptoms caused by ingesting melamine, the Health Ministry said Thursday. Three were in serious condition.

The official Xinhua News Agency said all six suspects arrested Thursday worked in Inner Mongolia, a region of sprawling grasslands that has become China's dairy heartland. Countless small dairy farms dot the grasslands, with milk collected at stations and then sold to large dairy companies.

One suspect, identified by Xinhua only by his surname Cui, ran a collection station and allegedly confessed to mixing about 25 gallons of water to 544 gallons of fresh milk. He then added 21 ounces — about three or four cups — of fake protein, which contained melamine, to hide the fact that it was diluted.

link to full article

Wednesday, October 22, 2008

Many biological medicines draw safety warnings

Why does follow-on monitoring for safety seem like such a strange idea?...

WASHINGTON, Oct 21 (Reuters) - About a quarter of biological medicines approved in the United States and Europe since 1995 have triggered safety warnings in the years after entering the market, Dutch researchers said on Tuesday.

Immune system disorders, infusion reactions, infections and cancer concerns were among the reasons for safety warnings for biological medicines, which are made with proteins derived from living cells rather than the chemicals used in typical drugs.

These medicines, called biologics or biologicals, are typically injected and treat a range of conditions including anemia, rheumatoid arthritis, hepatitis and cancer.

Thijs Giezen of Utrecht University in the Netherlands and colleagues tracked safety-related regulatory actions involving 174 biological medicines approved in the United States or the European Union between January 1995 and June 2007.

link to full article

Monday, October 20, 2008

Counterfeiters can get life in jail under new US Act

US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.

The passing of the Prioritizing Resources and Organization for Intellectual Property Act of 2007 (PRO IP) strengthens the US court’s power to punish those convicted of counterfeiting; a measure big pharma has been calling for.

By increasing its maximum penalty the US has brought its punishment more closely into line with China, which sentenced a man to life in prison for causing 14 deaths by using a fake ingredient in human immunoglobulin.

The sentence for inflicting serious bodily harm as a result of counterfeit products has also been increased and can now result in up to 20 years in jail. Both sentences can also carry a fine.

In addition to increasing the punishments for trafficking counterfeit goods the new legislation also ramps up US preventative powers.

link to full article

Friday, October 17, 2008

Chinese government summons major dairy companies

to buy up the plants of the company that produced contaminated milk...somehow these facilties have "great value"???...

BEIJING – China summoned five of its major dairy companies to a meeting Friday over the fate of Sanlu Group Co., the company at the center of a tainted milk scandal that has sickened thousands and led to the deaths of four children, state media reported.

The five companies were brought to Beijing to discuss the purchase of the company, the 21st Century Business Herald, a major business daily, reported Friday.

The government is trying to revive its dairy industry and contain the fallout after baby formula contaminated with melamine was blamed for the deaths of four infants and the sickening of about 54,000 other children in China.

The Health Ministry said Wednesday that 5,800 children were still hospitalized — six of them in serious condition. In Hong Kong, the Department of Health said Friday two more children have developed kidney stones after drinking melamine-laced milk, bringing to 10 the total number of children with milk-related kidney stones.

Sanlu, a majority state-owned company whose products were the most heavily tainted, is now largely defunct, with companies looking to scoop up its assets.

link to full article

Wednesday, October 15, 2008

Results are In: Pharma Favors Obama

I don't normally discuss politics at work, but...

an interesting post over at Pharma Marketing blog...

Tuesday, October 14, 2008

US proposes country-of-origin labelling

A good start...we have to start protecting ourselves...

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.

This proposal covers both active pharmaceutical ingredients (APIs) and excipients present in prescription or over-the-counter (OTC) products.

Including excipients under the bill differentiates it from the proposal in the draft of the US Food and Drug Administration (FDA) Globalization Act, which was released in April.

Under the proposal the country-of-origin of each active and inactive ingredient would be listed in descending order based upon the quantity in the finished dose.

It appears that it will not be necessary to include the country of origin of all raw materials and intermediates, or the nation in which every step in the synthesis process occurs.

This would provide a more comprehensive view of the origins of an API or excipient but is not mentioned in the bill, probably due to the complexity of implementing such a measure.

link to full article

China orders more testing for liquid milk, powder

BEIJING - China is ordering all liquid and powdered milk manufactured before Sept. 14 to be taken off the shelves for melamine testing, a news report said Tuesday, the first time Beijing has issued a blanket recall of products since the tainted dairy scandal broke last month.

It is the latest in a series of measures China has taken to allay worries over the quality of Chinese products and restore consumer confidence since four babies died and tens of thousands of children were sickened after drinking tainted milk.

Authorities have blamed dairy suppliers for the crisis, saying they added the industrial chemical melamine to watered-down milk to fool quality control tests and make the product appear rich in protein.

Melamine can cause kidney stones as the body tries to eliminate it and, in extreme cases, lead to life-threatening kidney failure.

Citing a notice jointly approved by six government ministries and administrations, the official Xinhua News Agency said Tuesday that all milk powder and liquid milk produced before Sept. 14 must be subject to testing nationwide by manufacturers.

link to full article

Thursday, October 09, 2008

Opportunity Knocks for Big Pharma in Credit Crunch

A good article regarding the impacts of the economic situation on the Pharma market over at FierceBiotech...

The primary consequence of the credit crunch for non-financial companies is the loss of access to cheap debt

LONDON, Oct. 8, 2008- The key impact of the credit crunch on the corporate world is the abrupt loss of cheap debt. During the late 1990s and 2000s companies across all industries have exploited easy access to cheap debt to amplify or ‘leverage' their return to investors. However, triggered by the sub-prime crisis and the subsequent collapse of big name financial institutions, banks have no choice but to protect their own capital and stop lending - turning off this supply of cheap debt.

This leaves those companies that have taken on debt in the extremely uncomfortable position of having to either rapidly pay off their debts (‘deleveraging') or re-secure new debt at much higher interest rates - potentially threatening the viability of the firm. Datamonitor believes that large pharmaceutical companies have wisely stayed out of the cheap debt game and as a result, the credit crunch will actually play out as a net positive for an industry much in need of good news, according to Datamonitor head of company analysis Dr. Chris Phelps. "Pharma companies are not only expected to weather the financial storm successfully but to also use this period to exploit their unique cash strength by embarking on an acquisition spree."

link to full article

Monday, October 06, 2008

China detains 6 more suspects in milk scandal

You can't "check Quality into" a product...

Maybe you can "arrest Quality into" a product...

BEIJING - China pledged to improve food safety after authorities detained six more people in the country's contaminated milk scandal as the government increases efforts to restore public trust in Chinese-made food products.

The head of China's quality watchdog said the country is also stepping up checks on its exports to ensure they conformed to the food safety standards of recipient countries, the official Xinhua News Agency reported.

The Chinese government has been scrambling to show it is tackling the problem of melamine-contaminated milk powder and products blamed for killing four babies and sickening more than 54,000 children with kidney stones and other illnesses in China.

"Food safety concerns not only the health of the public, but also the life of business," said Wang Yong, the director of the General Administration of Quality Supervision, Inspection and Quarantine, the agency responsible for ensuring that China's food supply chain is safe.

Wang, who replaced Li Changjiang, the former director who resigned last month in the wake of the scandal, vowed to make "a substantial change in the production and distribution of dairy products."

link to full article

Thursday, October 02, 2008

Candy with chemical in Chinese milk found in Conn.

And now we have to deal with it...

But look closely at Paragrapgh 9...when does it change from a few rogue companies contaiminating a product to "Standard Operating Procedure"???...

HARTFORD, Conn. - An industrial chemical blamed for sickening thousands of infants in China was found in candy in four Connecticut stores this week, a state official said Wednesday.

Days after contaminated White Rabbit Creamy Candy was found in California, Connecticut Consumer Protection Commissioner Jerry Farrell Jr. said tests found melamine in bags of the candy sold at two New Haven stores, a West Hartford market and an East Haven store.

"We're concerned, obviously, there may have been bags sold of these before we got to them," Farrell said.

Anyone who has the candy should destroy it, Farrell said.

The contamination has been blamed for the deaths of four children and kidney ailments among 54,000 others. More than 13,000 children have been hospitalized and 27 people arrested in connection with the tainting.

Melamine, which is high in nitrogen, is used to make plastics and fertilizers and experts say some amount of the chemical may be transferred from the environment during food processing. But in China's case, suppliers trying to boost output are believed to have diluted their milk, adding melamine because its nitrogen content can fool tests aimed at verifying protein content.

Melamine can cause kidney stones, leading to kidney failure. Infants are particularly vulnerable.

Melamine has been associated with contaminated infant formula and other Chinese products containing milk protein.

On Wednesday, the Chinese government identified 15 more Chinese dairy companies as producing milk products contaminated with melamine, bringing the total to 20 companies. At least 100 batches of milk powder have been found to contain the chemical, according to data on the food safety administration's Web site.

link to full article

Monday, September 29, 2008

FDA faulted for produce oversight

Who plans a "foodborne illness outbreak"???...

WASHINGTON (Reuters) - Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Friday.

The agency is also unclear on what it plans to do to shape up, the Government Accountability Office said.

"While FDA has considered fresh produce safety a priority for many years, resource constraints and other work -- including counterterrorism efforts and unplanned events such as foodborne illness outbreaks -- have caused FDA to delay key produce safety activities," the GAO report reads.

"FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending."

It said the FDA spent at least $20 million or about 3 percent of its food safety dollars on fresh produce in 2007.

The fresh produce industry has indicated it would welcome stronger regulation, especially after outbreaks of Salmonella carried by peppers from Mexico and that sickened 1,400 people from April to August of this year and an E. coli epidemic in 2006, traced to California spinach, that killed three.

link to full article

Tuesday, September 23, 2008

Rest of Sanofi's contaminated Lovenox recalled

The heparin saga continues...

PARIS, Sept 23 (Reuters) - French drugmaker Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) has recalled remaining batches of contaminated blood thinner Lovenox, a heparin, which were distributed before May 2008, French drug regulator Afssaps said.

Earlier this year, high levels of contamination with an oversulphated chondroitin sulphate in different types of heparin -- derived from pig intestines and used to prevent and treat blood clots -- were linked with serious side effects and deaths.

No such side effects were observed with Sanofi's Lovenox and the European Medicines Agency said in June doctors in Europe could continue to use the drug despite low levels of contamination found in some batches of the product.

link to full article

Monday, September 22, 2008

China's food safety chief quits over tainted milk

Four children dead, over 50,000 sick...this helps how?

BEIJING - The head of the Chinese agency that monitors food and product safety has resigned, state media announced Monday, pushed out by a scandal over tainted baby formula that killed four babies and sickened nearly 53,000.

Beijing authorities also said that China's biggest producer of powdered milk had known for months that its baby formula was tainted with the industrial chemical melamine. There were complaints about infant formula sold by the Sanlu Group Co. as early as December, 2007, China Central Television reported, citing an investigation by the State Council, China's Cabinet.

"During these eight months, the company did not inform the government and did not take proper measures, therefore making the situation worse," CCTV said.

Melamine, which can cause kidney stones and kidney failure in babies, has since been found in infant formula and other milk products from 22 of China's dairy companies.

link to full article

Thursday, September 18, 2008

Australia issues first license to clone human embryos

Is this the beginning of the Brave New World?...

SYDNEY (Reuters) - The Australian government has issued its first license allowing scientists to create cloned human embryos to try and obtain embryonic stem cells.

The in vitro-fertilization firm Sydney IVF was granted the license and reportedly has access to 7,200 human eggs for its research.

If the firm is successful it would be a world first, the Australian government's National Health and Medical Research Council (NHMRC), which granted the license, said on Wednesday.

Scientists in other countries have made stem cells they believe are similar to embryonic cells using a variety of techniques, but none have been able to extract embryonic stem cells from cloned human embryos.

link to full article

Wednesday, September 17, 2008

6,200 Chinese babies ill, 3 die from tainted milk

and so it continues...

BEIJING - The government was dispatching thousands of inspectors to monitor producers as officials reported Wednesday that the number of babies sick from tainted milk formula had climbed dramatically to nearly 6,200 from 1,200 a day earlier.

At least three children have died and more than 1,300 others, mostly newborns, remain hospitalized with dozens suffering from acute kidney failure.

Health Minister Chen Zhu said he expected the numbers of affected babies to increase as "more and more parents take kids to the hospital."

The head of China's quality control watchdog agency, Li Changjiang, said 5,000 inspectors will be sent out nationwide to monitor companies after government testing showed that 20 percent of the companies producing milk powder had dairy products with melamine.

link to full article

Monday, September 15, 2008

Thursday, September 11, 2008

New GMP Regs

The FDA has responded to industry comments with some new rules...

FDA publishes final rule on cGMP amendments

Tuesday, September 09, 2008

Biologists on the Verge of Creating New Form of Life

A team of biologists and chemists is closing in on bringing non-living matter to life.

It's not as Frankensteinian as it sounds. Instead, a lab led by Jack Szostak, a molecular biologist at Harvard Medical School, is building simple cell models that can almost be called life.

Szostak's protocells are built from fatty molecules that can trap bits of nucleic acids that contain the source code for replication. Combined with a process that harnesses external energy from the sun or chemical reactions, they could form a self-replicating, evolving system that satisfies the conditions of life, but isn't anything like life on earth now, but might represent life as it began or could exist elsewhere in the universe.

While his latest work remains unpublished, Szostak described preliminary new success in getting protocells with genetic information inside them to replicate at the XV International Conference on the Origin of Life in Florence, Italy, last week. The replication isn't wholly autonomous, so it's not quite artificial life yet, but it is as close as anyone has ever come to turning chemicals into biological organisms.

"We've made more progress on how the membrane of a protocell could grow and divide," Szostak said in a phone interview. "What we can do now is copy a limited set of simple [genetic] sequences, but we need to be able to copy arbitrary sequences so that sequences could evolve that do something useful."

By doing "something useful" for the cell, these genes would launch the new form of life down the Darwinian evolutionary path similar to the one that our oldest living ancestors must have traveled. Though where selective pressure will lead the new form of life is impossible to know.

"Once we can get a replicating environment, we're hoping to experimentally determine what can evolve under those conditions," said Sheref Mansy, a former member of Szostak's lab and now a chemist at Denver University.

Protocellular work is even more radical than the other field trying to create artifical life: synthetic biology. Even J. Craig Venter's work to build an artificial bacterium with the smallest number of genes necessary to live takes current life forms as a template. Protocell researchers are trying to design a completely novel form of life that humans have never seen and that may never have existed.

link to full article

Monday, September 08, 2008

FDA to List Drugs Being Investigated

Talk about "Direct to Consumer" marketing...this sound like "do it yourself" drug safety review...

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency's Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

link to full article

Friday, September 05, 2008

Meaningless genetic code helped form human hands

Genetic code once written off as meaningless is today show to have played a potential role in the evolution of the human ability to hold tools and walk upright.

The study is the latest in a long line of evidence to show that the genetics textbooks will have to be rewritten.

It underlines how, even though the human genetic code was read letter by letter for the first time in 2000, geneticists are still struggling to figure out what it means almost a decade later.

When scientists refer to genes, they mean stretches of DNA code that contain the instructions to make the proteins that build and operate the body.

When the genome was first unveiled, it was thought all human genes resided in only around 1.5 per cent of the cell's DNA, prompting some scientists so dismiss the other 98.5 per cent as "junk".

link to full article

Tuesday, September 02, 2008

Building boom meets maturing biotechs’ needs

Looking for biotech work?...go west, young man/ lady...

Even with some 1 million square feet of biotech office or R&D space on the Peninsula’s leasing market today, developers plan on bringing another 2.3 million square feet to the market over the next year or two.

The reason, say developers, brokers and biotech leaders, is simple: There’s still a need for space to match a maturing Bay Area biotech community. Still, developers are moving cautiously, building mostly to suit tenants and not getting too far in front of an industry known for stunning successes and equally brilliant burnouts.

“There’s always opportunity out there,” said Jennifer Von der Ahe, a project manager for Chamberlain Associates, which is developing more than 185,000 square feet in South San Francisco for neurological drugs maker Elan Corp.

“Biotech is not going away.”

link to full article

Wednesday, August 27, 2008

Producing heparin without the heartache

or without the Chinese deliberatley substtituing chemical contamination in lieu of actually producing the product they were paid to produce...but, hey, who's quiblling over details...

US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.

The breakthrough was presented at the ACS (American Chemical Society) National Meeting and Exposition in Philadelphia, US, earlier this week and described how Escherichia coli (E. coli) bacteria could be harnessed to synthesise the widely-used anticoagulant that has global annual sales of around $4bn (€2.7bn).

Heparin is produced by extraction from pig intestines and contaminated batches of the drug have been linked by the US FDA (Food and Drug Administration) to more than 80 deaths and hundreds of allergic reactions among patients treated with the drug during heart surgery and kidney dialysis.

The contaminated heparin was traced by the FDA to various batches imported from small, family-run workshops in China which supply about 70 per cent of the world’s supply.

While regulators called for greater cooperation and joint inspections of overseas active pharmaceutical ingredient (API) manufacturing plants, Professor Robert Linhardt of the Rensselaer Polytechnic Institute, US, and Associate Professor Jian Liu of the University of North Carolina, US, to search for an alternative method of production.

Prof. Linhardt was part of the team that identified the suspected contaminant as a structurally similar carbohydrate called oversulfated chondroitin sulfate.

"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," said Prof. Linhardt.

Researchers have been trying for years to develop a synthetic production method for the drug, however the first total synthesis described in 2003 by researchers from the Massachusetts Institute of Technology (MIT), US, produced only minute batches at a time and could not be economically scaled-up for commercial production.

The synthesis developed by Prof. Linhardt’s team uses a patented biosynthesis that uses enzymes expressed in E. coli bacteria to replicate the normal biosynthesis of natural heparin.

While the team has only used the technique to create the drug on a laboratory scale, scaling the process up should prove no more difficult than scaling-up the production of any other biological drug.

The group plans to begin the necessary preclinical and clinical trials needed to bring the synthetic heparin to market. If successful, the new heparin could be on the market in two to five years.

link to full article

Tuesday, August 26, 2008

FDA seizes drugs worth $74,000

How come we can't get this level of enforcement on real drugs??...

The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).

SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.

Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.

“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”

link to full article

Monday, August 25, 2008

Gene found for rare and deadly childhood cancer

News out of CHOP...

WASHINGTON (Reuters) - Researchers have found a gene that causes most inherited forms of neuroblastoma, a rare and deadly form of childhood cancer, and say the discovery points to new treatments.

Mutations in a gene called ALK were strongly linked to neuroblastoma, the researchers from the United States, Italy and Belgium reported on Sunday. They said several companies already are working on drugs that target this gene, which is also mutated in some cases of lung cancer and lymphoma.

"This discovery enables us to offer the first genetic tests to families affected by the inherited form of this disease," said Dr. Yael Mosse of The Children's Hospital of Philadelphia, who worked on the study.

"Furthermore, because there already are drugs in development that target the same gene in adult cancers, we can soon begin testing those drugs in children with neuroblastoma."

link to full article