And we still don't know what it might do to someone who is immunocompromised by HIV or by drugs,
The gene encodes a protein that is similar to molecular transporters that have been implicated in drug resistance.
and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted.
Healthy victims of swine flu should not routinely be given antiviral drugs, the World health organization useantivirals 20090820/en/index. html>warns.
WHO antiviralresistance 20090708/en/index. html>says the three incidences of drug resistant H1n1 to date are sporadic cases of resistance.
for example we invest heavily in public-private partnerships for developing new drugs, new diagnostic techniques, new vaccines.
for example malaria, every case could be cured with existing drugs, yet most people don't get them.
There's a researchable question in why 70%of the people who need the drugs for malaria don't get them.
a new antimalarial was launched as a licensed drug recently. It was a paediatric version of artemether-lumefantrine,
Kawaoka's team also confirmed that some commercially available antiviral drugs, including oseltamivir (marketed by Roche as Tamiflu)
are effective against the new pandemic virus in human cells grown in the lab. These drugs are already being used to treat some infected patients.
People infected with the H1n1 swine flu virus who are otherwise healthy should not routinely be given antiviral drugs,
THE WHO did recommend giving drugs to those presenting with severe illness, to children under five and to pregnant women (see http://tiny. cc/WHOH1N1).
the US Food and Drug Administration (FDA) halted plans for the world's first clinical trial of a therapy generated from human embryonic stem cells.
Drug development: Eli lilly abandoned development of its osteoporosis drug arzoxifene, after results from an advanced clinical trial suggested it did not offer sufficient benefit over currently available treatments.
The monoclonal antibody gained recommendations from an advisory committee at the Food and Drug Administration on 14 august,
Researchers will study drug development, bioengineering and imaging technologies at the two campuses. The chance to test therapies on different populations makes the collaboration particularly attractive for physicians.
Lawrence Deyton (pictured) was appointed to direct the new Center for Tobacco Products in Silver Spring, Maryland, part of the Food and Drug Administration (FDA.
and Drug Administration (FDA) to approve a device to repair damaged knees against the recommendations of its own scientists,
and women from Thailand found that a combination of two older drugs, which had failed to work individually, together reduced the risk of contracting HIV by nearly a third.
Business Drug deal: The drug company Abbott laboratories in Abbott Park, Illinois, is to buy Solvay Group's pharmaceutical business for  4. 5 billion (US$6. 6 billion.
Movetis has European approval to market a constipation drug, prucalopride (Resolor). Market watch Amazonian nations will be the early winners in any market for forest carbon credits,
Drug-maker Glaxosmithkline (GSK) was aware of cardiac risks associated with its diabetes drug Avandia (rosiglitazone) years before they became public
Two senators also challenged Margaret Hamburg, the commissioner of the US Food and Drug Administration (FDA),
to justify an ongoing trial that compares Avandia with a competing drug. The finance committee released documents from the FDA where an advisory committee voted in 2007 to keep Avandia on the market in
London-based pharma giant Glaxosmithkline revealed plans on 4 february to shut down early-stage research into pain and depression medications,
to treat multiply drug-resistant tuberculosis simply isn't a good idea. The reason the problem arises at all is
Soil bacteria could yield drug to treat roundworm: Nature Newsa bacterial protein used in a common pesticide kills intestinal parasitic roundworms in mice
Compared to the best drugs people have developed to treat human parasitic worms this natural protein is at least three times better,
Nearly all of the current drugs to treat nematode diseases were invented for veterinary purposes, he says,
give me the best vet drug you have for treating my condition? he says. This is the only disease
biochemistry and pharmacology. go. nature. com/Errfze 27-29 april The Cambridge Healthtech Institute's Drug Discovery Chemistry conference is held in San diego, California,
with programmes on antibacterial drug development and protein-protein interactions as drug targets. www. drugdiscoverychemistry. com 28-29 april A symposium hosted by the Zoological Society of London examines the link between the conservation of biodiversity
and for conducting clinical trials of its drugs. Pfizer said it paid out US$35 million in the last six months of 2009.
It was required to post much of the data by an agreement settling a US government investigation into the company's promotion of its drugs for off-label use.
after the Food and Drug Administration began an investigation into whether the kits require regulatory approval.
based in New york. The US firm is known best for its anticancer drug erlotinib (Tarceva). Business watch Investors are losing confidence in Monsanto,
On 24 may, the US Food and Drug Administration (FDA) fined Genzyme US$175 million for poor oversight at one of its manufacturing plants.
to clean the plant will cause shortages of three drugs, including one used to treat thyroid cancer.
Last year, a US Food and Drug Administration committee recommended that the drug be approved for certain patients,
Analysts predict multibillion-dollar annual sales for the drug. Pharma R&d shuffle: Astrazeneca has hired Pfizer's research and development (R&d) chief, Martin Mackay,
Mackay became head of R&d at Pfizer, the world's biggest drug maker, in 2007,
and drug resistance hadn't developed. We have been aided by pure good luck she said. Research Student gene-testing dropped:
The chief executive of India's biggest drug maker, Ranbaxy, resigned unexpectedly last week, citing differences of opinion with parent company Daiichi Sankyo,
a major player in the generic drugs market and headquartered in Gurgaon, for little more than a year.
and Drug Administration accused the company of falsifying safety data. Ranbaxy announced net profits of 3. 3 billion rupees (US$71 million) for the year's second quarter, down 50%on the previous year but above analysts'expectations.
Generic drugs maker Aspen Pharmacare, based in Durban, South africa, will buy the drugs manufacturing unit of Australian company Sigma Pharmaceuticals for Aus$900 million (US$806 million).
Aspen, which is owned 19 by pharmaceutical giant Glaxosmithkline, headquartered in London, and is Africa's largest drugs manufacturer,
wanted to expand its position in the Australian generics market. It announced the deal on 16 august.
Business watch A generation of drugs with the potential to cure hepatitis C is set to flood the market.
and drug behemoth Merck, headquartered in Whitehouse Station, New jersey, both released promising results from late-stage clinical trials of their leading drugs against the hepatitis C virus (HCV).
Merck's drug boceprevir and Vertex's telaprevir both block HCV's protease enzyme and 墉 combined with the standard treatment 墉 cured 66%and 72%of patients respectively in phase
If the drugs are approved by mid-2011, as their manufacturers hope, they will take the early lead in an HCV-drug field that could grow to be worth US$15 billion by 2017, according to Irena Melnikova, a life-sciences analyst at TVM Capital in Boston, Massachusetts.
whether a drug is likely to work or not, the hospital tests patients for some 150 mutations in more than a dozen cancer-causing genes,
These data could reveal how drugs targeting one molecular pathway are affected by mutations in another gene
African innovation Africa is struggling to turn local discoveries into drugs and other health-care inventions
including several drug candidates and a dipstick test for schistosomiasis. Scientists have no incentive to commercialize results,
a drug-development programme of up to US$500 million authorized in this year's health-care reform law.
and Drug Administration broad new food-policing powers. The agency would also have to identify the most significant contaminants
Red wine drug Drug company Glaxosmithkline (GSK) has halted all development of a proprietary formulation of resveratrol a chemical found in red wine
Business Orphan drugs European spending on research and development (R&d) of'orphan'drugs for rare diseases jumped from ¢ 158 million (US$207 million) in 2000 to nearly ¢Â
In that same period, global R&d spending on orphan drugs grew from ¢ 305 million to ¢ 1. 9 billion
French drug reform France's health minister Xavier Bertrand last week pledged to reform the country's drug-regulation system in the wake of a damning official report into why the weight-loss drug Mediator
The french state body that approves drugs for marketing, banned the drug only in 2009, even though questions were raised about its impact on heart disease more than a decade ago,
a delay that the report says may have contributed to some 500 premature deaths. The AFSSAPS will now investigate 76 other products,
Of this, some $60 million should be used to boost research activities including developing classes of antimalarials to replace the artemisinins, currently the most potent antimalaria drugs.
Published last week, THE WHO's plan for containing resistance to the drugs also calls for increased monitoring,
as only 31 of the 75 countries that should be routinely testing the drugs'efficacy did so in 2010.
Business watch In 2011 and 2012, the drug industry will face the worst effects of its'patent cliff'
as several major drugs face competition from generics. The world's best-selling drug 墉 Pfizer's cholesterol-lowering medication Lipitor (atorvastatin) 墉 may face competition from generics maker Ranbaxy of Gurgaon, India.
Other blockbusters due to come off patent include Sanofi-aventis's anti-clotting drug Plavix (clopidogrel) and Eli lilly's schizophrenia drug Zyprexa (olanzapine.
Research Plant catalogue A working list of known land plant species 墉 a key tool for conservation efforts 墉 was released at the end of 2010 (see www. theplantlist. org.
%.And funding for organizations that manage private public partnerships to develop drugs dropped by 8. 6,
Business Obesity drug upset US regulators have rejected another obesity drug, despite an earlier recommendation from advisers to conditionally approve it.
On 1 february, the Food and Drug Administration (FDA) told Orexigen Therapeutics of La jolla, California, that concerns about the possible cardiovascular risks of the drug Contrave (naltrexone/bupropion) outweighed its weight-loss benefit.
It asked for further clinical trials. Orexigen's share price fell by 72%following the news. Last year,
member states of the World health organization (WHO) will send samples of flu virus to laboratories and drug makers around the world,
Business Hepatitis approvals As expected, the US Food and Drug Administration has approved what is only the second drug to directly target the hepatitis C virus. Telaprevir (Incivek),
Takeda drug deal Japanese drug giant Takeda will buy Swiss drug maker Nycomed for ¢ 9. 6 billion (US$13. 6 billion),
Global drug safety Pronouncing itself at the centre of a global bazaar, the US Food and Drug Administration (FDA) has announced its intention to assemble an international coalition of regulatory agencies to strengthen product safety worldwide.
In a report released on 20 june, the FDA says that it will build a global data network that will allow regulators to proactively share real-time information.
the report notes, for example, that 80%of the active ingredients in medications sold in the United states come from elsewhere.
Drug-approval race Since 2003 the US Food and Drug Administration (FDA) has approved more cancer drugs than the European Medicines Agency (EMA),
and approved those drugs more quickly, according to a report in Health Affairs on 16 june. Up to the end of March 2010, the US agency had approved 32 new anticancer drugs,
whereas the EMA had approved 26. The median time from submission to approval was 182 days in the United states and 350 days in Europe.
Janet Woodcock, the FDA's top drug-approval official, says that the difference extends to all categories of drug.
See go. nature. com/ouxsup for more. UK health research The UK government has promised that medical research will receive greater attention in its revised proposals for reforming the country's public health service,
because the bacteria are thought to respond to the medication by increasing production of the Shiga toxin,
Research targeting mosquito control is compared grossly underfunded with that on malaria drugs and vaccines she adds,
Nature Newsthe first drug to show signs of not just halting multiple sclerosis (MS), but actually reversing the nerve damage caused by the condition,
Ludwig Kappos, chair of neurology at the University Hospital of Basel in Switzerland, who has been involved in several MS drug trials,
the drug tackles the mechanisms that cause damage to cells by effectively resetting the immune system.
The drug brings an increased risk of autoimmune diseases. In the trial, 18.1%of people taking alemtuzumab experienced thyroid-related autoimmune responses,
The drug is approved already in many countries as a treatment for some forms of leukaemia and lymphoma, under the name Campath.
it is legal to prescribe any drug for off-label use, and so patients have started already using it to treat MS,
But it is not just MS patients who have been holding their breath over this drug,
and a range of other therapies, was acquired by Paris-based drug-maker Sanofi. The value of the deal for Genzyme's shareholders is contingent on the success of alemtuzumab in treating MS;
the first milestone is for the drug to gain approval from the US Food and Drug Administration before the end of March 2014.
BUSINESSVIOXX fines Drug-maker Merck will pay US$950 million to settle investigations into how it marketed the painkiller Vioxx,
had to pull the blockbuster arthritis drug from the market in 2004, after five years of sales.
Lipitor patent ends The world's best-selling drug, Pfizer's cholesterol-lowering medication Lipitor (atorvastatin) now faces competition from generics,
The drug has brought in more than US$100 billion in sales for the pharma company, based in New york,
The US Food and Drug Administration had planned to mandate graphic health warnings on packets from September 2012,
Business Avandia fine Drug giant Glaxosmithkline (GSK) announced on 3 november that it has agreed to pay US$3 billion to settle a bevy of US federal investigations into the way it has developed
and marketed some of its biggest-selling drugs. Foremost among these is Avandia (rosiglitazone), a once-dominant diabetes drug, sales
of which were banned in Europe and restricted in the United states last year after concerns that it increased risks of heart attack and stroke.
when a US Senate committee concluded that GSK had known about the drug's heart risks for more than a decade without reporting them to regulators.
and Fermilab in Batavia, Illinois. Policy Drug approvals rise The US Food and Drug Administration approved more innovative drugs this year than in any year of the past decade,
except for 2009, the agency said last week. In the US government's fiscal year 2011,
¢â presents recommendations for avoiding future food crises. ccafs. cgiar. org/commission Number crunch $131 bn Lifetime sales of Pfizer's cholesterol-lowering drug
Preventing HIV Pharmaceutical firm Gilead Sciences wants to sell anti-HIV drugs to healthy people,
and Drug Administration to sell its two-in-one antiretroviral medication Truvada (emtricitabine/tenofovir disoproxil fumarate) to people not infected with HIV.
its products include biological drugs for rheumatoid arthritis and anaemia. SOURCE: GTM RES.//SEIAUS solar-energy installations spiked during the third quarter of 2011,
Those given the experimental monoclonal antibody pertuzumab and the widely used drug trastuzumab (Herceptin), together with chemotherapy, gained an extra 6-month lull in disease progression compared with women receiving only chemotherapy and trastuzumab.
and Drug Administration (FDA) and denied girls under 17 access to the emergency contraceptive levonorgestrel known as the morning-after pill,
Drug-makers Teva had asked that the pill be made available over the counter to girls, and FDA research had found it to be safe and effective.
Scientists contacted By nature say that basic research on such mutated strains may eventually yield insight relevant to developing pandemic countermeasures such as drugs and vaccines.
Antibiotic ban The US Food and Drug Administration is restricting some uses of a major class of antibiotic in farm animals,
which microbes acquire resistance to the drugs. On 4 january, the agency banned unapproved uses of cephalosporins in cattle, pigs,
See go. nature. com/qjoqfn for more on hepatitis C drugs. Teva rethink Israeli pharmaceutical firm Teva, the world's largest maker of generic drugs, may shift its focus towards branded medicines after it announced a new chief executive.
Jeremy Levin, former head of strategy and alliances at Bristol-myers squibb in New york city, has a reputation for making external partnerships
and Drug Administration (FDA) is now moving to protect key antibiotics known as cephalosporins, which are used in humans to treat a range of infections,
because overuse of the drugs is"likely to contribute to cephalosporin-resistant strains of certain bacterial pathogens.
"doctors may have to use drugs that are not as effective, or that have greater side effects.
In animals not listed in the FDA order, such as ducks or rabbits, vets will have more discretion to use the drugs.
It is reviewing comments on rules that would prohibit the use of any antimicrobial drug to promote animal growth
"We would support greater veterinary oversight of antimicrobial drugs, says Christine Hoang, assistant director of scientific activities at the American Veterinary Medical Association in Schaumburg, Illinois. The European union (EU),
and to develop new antimicrobial drugs. Antimicrobial resistance is also this year s top priority for the intergovernmental World organisation for Animal health (OIE),
The three organizations plan to urge governments to put vets in charge of allocating the drugs
BUSINESS Biosimilars rules Drug-makers keen to sell generic forms of branded biological drugs such as enzymes and antibodies were excited to finally see draft guidance on the matter emerge from the US Food and Drug
so it is much harder to copy drugs based on them than small-molecule drugs (see Nature 449,274-276;
has rejected, as expected a US$5. 7-billion takeover bid by drug giant Roche, based in Basel, Switzerland.
and drug regulatory agencies should consider adopting deep-sequencing techniques to screen herbal medicines; his team has applied for a grant to test its methods on supplements that are on the market in Australia.
In 2010 the European union (EU) banned most flukocide drugs because they leave toxic residues in milk.
The milk from cows that receive the remaining two allowed drugs is undrinkable for three days after treatment.
"Weed resistance is a game changer for agriculture in the same way that drug resistance has been a game changer for the health-care industry,
while the US Food and Drug Administration (FDA) works out how to regulate them. Exemplar Genetics
they are desirable models for drug testing and for studying the disease process. However, as the first company to seek approval for a disease model in a GE animal that could, in theory,
Nonetheless, Swart is worried about the regulatory process for new animal drugs (NAD), which applies to all GE animals,
whether they re bred to produce food, drugs or, in Swart s case, disease.""The NAD process doesn t fit us real well,
Moreover, without approval, Exemplar cannot promote the pig models for drug testing based on what the researchers find.
whether a drug will work.""It s critical to figure out how to do this right with the FDA,
and donors seeking to use anti-malaria drugs as prophylactics in African children, and the analysis pinpoints where the strategy would be most effective,
malaria burden, predicted malaria seasonality and the efficacy of the drug combination sulphadoxine, pyrimethamine and amodiaquine (SP-AQ.
when drugs are taken as a prophylaxis, which is why THE WHO requires that people on SP-AQ take different medications
if they acquire the disease. At about US$1. 50 for up to four monthly treatments, a season's worth of SP-AQ would cost less than malarone or mefloquine,
That's because in addition to procuring the drugs, Nahlen says, countries will need to pay health workers to distribute the medicine,
Gene therapy Europe s drugs regulator has recommended for the first time a gene therapy for approval. Glybera, a treatment for a rare disease in which patients cannot produce enough lipoprotein lipase (an enzyme crucial for breaking down fat),
Second obesity pill Just weeks after it approved its first weight-loss drug in 13 years,
the US Food and Drug Administration on 17 Â July gave the green light to a second obesity treatment:
although it carries a warning that those taking the drug should have monitored their heart rates. See go. nature. com/vtcifa for more.
But the case was reopened after two separate patents covering a way to determine drug dosage, from Prometheus Laboratories in San diego,
Pharma fines Drug giant Glaxosmithkline will pay US$3 billion in fines for enormous health-care fraud.
Obesity pill The US Food and Drug Administration (FDA) approved a new weight-loss drug on 27 june
The agency rejected the drug two years ago because of safety concerns, but after additional tests it is now allowing Belviq s use in obese adults
and the two firms will share profits and losses from Amylin s drugs pipeline. G. WOOD/AFP/GETTY IMAGESCARBON tax Australia introduced a carbon tax on 1 Â July, in
such as measures to speed up approval of generic versions of protein-based drugs. See page 13 for more. UK science chief Mark Walport will be the United kingdom s next chief scientific adviser
Drug-discovery split Irish pharmaceutical company Elan is to split into two, completely separating its drug-discovery work from the main business.
The firm which is based in Dublin, plans to spin off its research work into a small separate company called Neotope Biosciences,
Elan itself will keep ownership of assets such as its stake in multiple-sclerosis drug Tysabri (natalizumab.
A. DI MEO/EPA/CORBISITALIAN dog-breeding facility at risk One of the largest suppliers of beagles (pictured) for mandatory drug testing in Europe could struggle to survive after an Italian court ordered its temporary closure
Gene-test regulation Personal-genetics company 23andme announced on 30 Â July that it was seeking approval from the US Food and Drug Administration (FDA) for its genetic tests related to health
Alzheimer s setback Research has been halted on a keenly watched experimental drug aimed at treating Alzheimer s disease after it failed two late-stage clinical trials.
and one on 6 august the drug did not prevent cognitive decline. Source: Thomson Reuters/Sciencewatchresearch papers with a single author are becoming a rare breed,
and expense off the drug-development process, says Garry Neil, head of Transcelerate and a former vice-president of science and technology at Johnson & johnson. Smaller companies are invited to join the team.
and the US Food and Drug Administration released reports that found inorganic arsenic in rice products.
Walter P. Reuther Library, Wayne State Univ. AZT-maker dies Jerome Horwitz, the chemist who inadvertently created the first antiretroviral drug for AIDS,
but he shelved the drug after it showed little efficacy against the disease. A company that later became part of Glaxosmithkline patented AZT in the 1980s
But culturing mammalian cells is currently the only way to make some complex protein drugs.
and the high production costs mean that the drugs can cost hundreds of thousands of dollars a year.
In May, the US Food and Drug Administration approved Elelyso (taliglucerase alfa) a drug for the lysosomal storage disorder Gaucher disease which is produced in cultured carrot cells.
And drugs made in duckweed safflower and tobacco have progressed as far as clinical trials. However, making proteins with certain sugar patterns using these systems is still difficult or impossible.
But there is a long way to go before maize-made drugs reach the market, says Kermode.
however, maize may one day become the go-to way to make complex protein drugs
His FDA has slowed the drug development process and inserted requirements that drive up the cost of developing new antibiotics.
I signed the most comprehensive reform of our nation s food safety laws in more than 70 years â oe giving the Food and Drug Administration the resources,
The US Food and Drug Administration has collected not routinely data on acrylamide in food since 2006,
Diet-pill concern Europe s drug regulators have recommended against approving a diet pill recently cleared for sale in the United states. The European Medicines Agency s Committee for Medicinal Products for Human Use
But some 3. 7%of new TB cases are now multi-drug resistant. In some countries in Eastern europe and Central asia, multi-drug resistance occurs in more than 20%of cases (see chart.
Because of incorrect diagnoses and a shortage of data in some places, even this is probably an underestimate.
but rarely funds proposals to produce drugs or vaccines in the milk of transgenic livestock.
where advocates of GE animal research aired their frustrations with the US Food and Drug Administration (FDA),
A brief history of some of the genetically engineered food animals submitted to the US Food and Drug Administration (FDA) for review.
The FDA evaluates animals as strictly as it does drugs. In the 17 Â years that the salmon has been under review
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